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Document 52013AP0428
Amendments adopted by the European Parliament on 22 October 2013 on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 — C7-0318/2012 — 2012/0266(COD))
Amendments adopted by the European Parliament on 22 October 2013 on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 — C7-0318/2012 — 2012/0266(COD))
Amendments adopted by the European Parliament on 22 October 2013 on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 — C7-0318/2012 — 2012/0266(COD))
IO C 208, 10.6.2016, p. 310–473
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
10.6.2016 |
EN |
Official Journal of the European Union |
C 208/310 |
P7_TA(2013)0428
Medical devices ***I
Amendments adopted by the European Parliament on 22 October 2013 on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 — C7-0318/2012 — 2012/0266(COD)) (1)
(Ordinary legislative procedure: first reading)
(2016/C 208/20)
Amendment 1
Proposal for a regulation
Recital 1 a (new)
Text proposed by the Commission |
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Amendment 2
Proposal for a regulation
Recital 2
Text proposed by the Commission |
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Amendment 3
Proposal for a regulation
Recital 2 a (new) — sentence 1 (new)
Text proposed by the Commission |
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Amendment 4
Proposal for a regulation
Recital 2 a (new) — sentence 2 (new)
Text proposed by the Commission |
Amendment |
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Directive 2010/63/EU of the European Parliament and of the Council (3) states that tests on vertebrate animals must be replaced, restricted or refined. |
Amendment 5
Proposal for a regulation
Recital 3
Text proposed by the Commission |
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Amendment 6
Proposal for a regulation
Recital 3 a (new)
Text proposed by the Commission |
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Amendment 7
Proposal for a regulation
Recital 7
Text proposed by the Commission |
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Amendment 8
Proposal for a regulation
Recital 7 a (new)
Text proposed by the Commission |
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Amendment 9
Proposal for a regulation
Recital 8
Text proposed by the Commission |
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Amendment 10
Proposal for a regulation
Recital 11 a (new)
Text proposed by the Commission |
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Amendment 11
Proposal for a regulation
Recital 12
Text proposed by the Commission |
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Amendment 12
Proposal for a regulation
Recital 12 a (new)
Text proposed by the Commission |
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Amendment 13
Proposal for a regulation
Recital 12 b (new)
Text proposed by the Commission |
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Amendment 14
Proposal for a regulation
Recital 13
Text proposed by the Commission |
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Amendment 15
Proposal for a regulation
Recital 13 a (new)
Text proposed by the Commission |
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Amendment 16
Proposal for a regulation
Recital 15 a (new)
Text proposed by the Commission |
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Amendment 17
Proposal for a regulation
Recital 19
Text proposed by the Commission |
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Amendment 18
Proposal for a regulation
Recital 19 a (new)
Text proposed by the Commission |
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Amendment 19
Proposal for a regulation
Recital 21 a (new)
Text proposed by the Commission |
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Amendment 20
Proposal for a regulation
Recital 24
Text proposed by the Commission |
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Amendment 21
Proposal for a regulation
Recital 25 a (new)
Text proposed by the Commission |
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Amendment 22
Proposal for a regulation
Recital 27
Text proposed by the Commission |
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Amendment 24
Proposal for a regulation
Recital 31 a (new)
Text proposed by the Commission |
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Amendment 25
Proposal for a regulation
Recital 32
Text proposed by the Commission |
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Amendment 26
Proposal for a regulation
Recital 33
Text proposed by the Commission |
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Amendment 27
Proposal for a regulation
Recital 34
Text proposed by the Commission |
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Amendment 28
Proposal for a regulation
Recital 35
Text proposed by the Commission |
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Amendment 29
Proposal for a regulation
Recital 36
Text proposed by the Commission |
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Amendment 30
Proposal for a regulation
Recital 37
Text proposed by the Commission |
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Amendment 31
Proposal for a regulation
Recital 39
Text proposed by the Commission |
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Amendment 32
Proposal for a regulation
Recital 39a (new)
Text proposed by the Commission |
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Amendment 33
Proposal for a regulation
Recital 39 b (new)
Text proposed by the Commission |
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Amendment 34
Proposal for a regulation
Recital 40
Text proposed by the Commission |
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Amendment 35
Proposal for a regulation
Recital 42
Text proposed by the Commission |
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deleted |
Amendments 363 and 370
Proposal for a regulation
Recital 42 a (new)
Text proposed by the Commission |
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Amendment 379
Proposal for a regulation
Recital 42 b (new)
Text proposed by the Commission |
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Amendment 364
Proposal for a regulation
Recital 42 c (new)
Text proposed by the Commission |
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Amendment 38
Proposal for a regulation
Recital 45
Text proposed by the Commission |
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Amendment 39
Proposal for a regulation
Recital 47
Text proposed by the Commission |
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Amendment 40
Proposal for a regulation
Recital 47 a (new)
Text proposed by the Commission |
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Amendment 41
Proposal for a regulation
Recital 48 a (new)
Text proposed by the Commission |
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Amendment 43
Proposal for a regulation
Recital 50
Text proposed by the Commission |
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Amendment 44
Proposal for a regulation
Recital 51 a (new)
Text proposed by the Commission |
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Amendment 45
Proposal for a regulation
Recital 52
Text proposed by the Commission |
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Amendment 46
Proposal for a regulation
Recital 53
Text proposed by the Commission |
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Amendment 47
Proposal for a regulation
Recital 54
Text proposed by the Commission |
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Amendment 48
Proposal for a regulation
Recital 54 a (new)
Text proposed by the Commission |
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Amendment 49
Proposal for a regulation
Recital 56
Text proposed by the Commission |
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Amendment 50
Proposal for a regulation
Recital 57
Text proposed by the Commission |
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Amendment 51
Proposal for a regulation
Recital 57 a (new)
Text proposed by the Commission |
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Amendment 52
Proposal for a regulation
Recital 58
Text proposed by the Commission |
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Amendment 53
Proposal for a regulation
Recital 58 a (new)
Text proposed by the Commission |
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Amendment 54
Proposal for a regulation
Recital 59
Text proposed by the Commission |
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Amendment 55
Proposal for a regulation
Recital 61
Text proposed by the Commission |
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Amendment 56
Proposal for a regulation
Recital 63
Text proposed by the Commission |
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Amendment 57
Proposal for a regulation
Recital 64
Text proposed by the Commission |
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Amendment 58
Proposal for a regulation
Recital 68
Text proposed by the Commission |
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Amendment 59
Proposal for a regulation
Article 1 — paragraph 1 — subparagraph 1
Text proposed by the Commission |
Amendment |
This Regulation establishes rules to be complied with by medical devices and accessories to medical devices that are placed on the market or put into service in the Union for human use . |
This Regulation establishes rules to be complied with by medical devices for human use, accessories to medical devices and medical devices for aesthetic purposes that are placed on the market or put into service in the Union. |
Amendment 60
Proposal for a regulation
Article 1 — paragraph 1 — subparagraph 2
Text proposed by the Commission |
Amendment |
For the purposes of this Regulation, medical devices and accessories to medical devices shall hereinafter be referred to as ‘devices’. |
For the purposes of this Regulation, medical devices, accessories to medical devices and devices for aesthetic purposes shall hereinafter be referred to as ‘devices’. |
Amendment 61
Proposal for a regulation
Article 1 — paragraph 2 — point f
Text proposed by the Commission |
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Amendment 62
Proposal for a regulation
Article 1 — paragraph 4 — subparagraph 1
Text proposed by the Commission |
Amendment |
Where a device, when placed on the market or used in accordance with the manufacturer's instructions, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in Article 1(10) of that Directive, with action ancillary to that of the device, that device shall be assessed and authorised in accordance with this Regulation. |
Where a device, when placed on the market or used in accordance with the manufacturer's instructions, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in Article 1(10) of that Directive, with action ancillary to that of the device, that device shall be assessed and authorised in accordance with this Regulation following consultation with the national medicine agency or with the EMA . |
Amendment 63
Proposal for a regulation
Article 1 — paragraph 5 a (new)
Text proposed by the Commission |
Amendment |
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5a. This Regulation shall not impede the continued application of measures within Directive 2002/98/EC and its five Daughter Directives setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components. |
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Articles 10 (Personnel), 14 (Traceability), 15 (Notification of serious adverse events and reactions), 19 (Examination of donors) and 29 (Technical requirements and their adaptation to technical and scientific progress) of Directive 2002/98/EC ensure donor and patient safety and as such those existing standards shall be maintained. |
Amendment 64
Proposal for a regulation
Article 1 — paragraph 7 a (new)
Text proposed by the Commission |
Amendment |
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7a. The regulation of medical devices at Union level shall not interfere with the freedom of Member States to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation. |
Amendment 65
Proposal for a regulation
Article 2 — paragraph 1 — point 1 — introductory part
Text proposed by the Commission |
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Amendment 66
Proposal for a regulation
Article 2 — paragraph 1 — point 1 — indent 1
Text proposed by the Commission |
Amendment |
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Amendment 67
Proposal for a regulation
Article 2 — paragraph 1 — point 1 — paragraph 2
Text proposed by the Commission |
Amendment |
The implantable or other invasive products, intended to be used for human beings, which are listed in Annex XV shall be considered medical devices, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose. |
The implantable or other invasive products, as well as products using external physical agents, intended to be used for human beings, which are listed on a non-exhaustive basis in Annex XV, shall be considered medical devices for the purposes of this Regulation , regardless of whether or not they are intended by the manufacturer to be used for a medical purpose. |
Amendment 68
Proposal for a regulation
Article 2 — paragraph 1 — point 2
Text proposed by the Commission |
Amendment |
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Amendment 69
Proposal for a regulation
Article 2 — paragraph 1 — point 2 a (new)
Text proposed by the Commission |
Amendment |
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Tattooing products and piercings shall not be considered devices for aesthetic purposes. |
Amendment 70
Proposal for a regulation
Article 2 — paragraph 1 — point 3
Text proposed by the Commission |
Amendment |
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However, mass-produced devices which need to be adapted to meet the specific requirements of a doctor of medicine, a dental practitioner or any other professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of doctors of medicine, dental practitioners or any other authorised person shall not be considered to be custom-made devices; |
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Amendment 71
Proposal for a regulation
Article 2 — paragraph 1 — point 4 — paragraph 1
Text proposed by the Commission |
Amendment |
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Amendment 72
Proposal for a regulation
Article 2 — paragraph 1 — point 4 — paragraph 2
Text proposed by the Commission |
Amendment |
Stand alone software shall be considered an active device; |
deleted |
Amendment 73
Proposal for a regulation
Article 2 — paragraph 1 — point 8 — paragraph 1
Text proposed by the Commission |
Amendment |
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Amendment 357
Proposal for a regulation
Article 2 — paragraph 1 — point 8 a (new)
Text proposed by the Commission |
Amendment |
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Amendment 75
Proposal for a regulation
Article 2 — paragraph 1 — point 9
Text proposed by the Commission |
Amendment |
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deleted |
Amendment 354
Proposal for a regulation
Article 2 — paragraph 1 — point 10
Text proposed by the Commission |
Amendment |
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Amendment 76
Proposal for a regulation
Article 2 — paragraph 1 — point 16
Text proposed by the Commission |
Amendment |
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Amendment 77
Proposal for a regulation
Article 2 — paragraph 1 — point 24
Text proposed by the Commission |
Amendment |
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Amendment 78
Proposal for a regulation
Article 2 — paragraph 1 — point 27
Text proposed by the Commission |
Amendment |
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Amendment 79
Proposal for a regulation
Article 2 — paragraph 1 — point 31 a (new)
Text proposed by the Commission |
Amendment |
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Amendment 80
Proposal for a regulation
Article 2 — paragraph 1 — point 31 b (new)
Text proposed by the Commission |
Amendment |
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Amendment 82
Proposal for a regulation
Article 2 — paragraph 1 — point 32
Text proposed by the Commission |
Amendment |
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Amendment 83
Proposal for a regulation
Article 2 — paragraph 1 — point 33 — paragraph 1 a (new)
Text proposed by the Commission |
Amendment |
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Clinical investigations for medical devices, where made compulsory in accordance with this Regulation, shall include clinical investigations in the appropriate target population and well-controlled investigations. |
Amendment 84
Proposal for a regulation
Article 2 — paragraph 1 — point 36 — introductory part
Text proposed by the Commission |
Amendment |
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Amendment 86
Proposal for a regulation
Article 2 — paragraph 1 — point 37
Text proposed by the Commission |
Amendment |
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Amendment 87
Proposal for a regulation
Article 2 — paragraph 1 — point 37 a (new)
Text proposed by the Commission |
Amendment |
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Amendment 88
Proposal for a regulation
Article 2 — paragraph 1 — point 37 b (new)
Text proposed by the Commission |
Amendment |
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Amendment 89
Proposal for a regulation
Article 2 — paragraph 1 — point 39 — indent 2 — point iii
Text proposed by the Commission |
Amendment |
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Amendment 90
Proposal for a regulation
Article 2 — paragraph 1 — point 39 — indent 3
Text proposed by the Commission |
Amendment |
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Amendment 91
Proposal for a regulation
Article 2 — paragraph 1 — point 40
Text proposed by the Commission |
Amendment |
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Amendment 92
Proposal for a regulation
Article 2 — paragraph 1 — point 48 a (new)
Text proposed by the Commission |
Amendment |
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Amendment 93
Proposal for a regulation
Article 3
Text proposed by the Commission |
Amendment |
1. The Commission may, at the request of a Member State or on its own initiative , by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). |
1. The Commission may on its own initiative or shall at the request of a Member State, by means of implementing acts on the basis of the opinions of the MDCG and the MDAC referred to in Articles 78 and 78a respectively , determine whether or not a specific product, or category or group of products, including borderline products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). |
2. The Commission shall ensure the sharing of expertise between Member States in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products in order to determine the appropriate regulatory status of a product, or category or group of products. |
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Amendment 256
Proposal for a regulation
Chapter II — title
Text proposed by the Commission |
Amendment |
Making available of devices, obligations of economic operators, reprocessing, CE marking, free movement |
Amendment 94
Proposal for a regulation
Article 4 — paragraph 4
Text proposed by the Commission |
Amendment |
4. Devices that are manufactured and used within a single health institution shall be considered as being put into service. The provisions regarding CE marking referred to in Article 18 and the obligations laid down in Articles 23 to 27 shall not apply to those devices, provided that manufacture and use of those devices occur under the health institution's single quality management system. |
4. Devices that are manufactured and used within a single health institution shall be considered as being put into service. The provisions regarding CE marking referred to in Article 18 and the obligations laid down in Articles 23 , 26 and 27 shall not apply to those devices, provided that manufacture and use of those devices occur under the health institution's single quality management system. |
Amendment 95
Proposal for a regulation
Article 4 — paragraph 5
Text proposed by the Commission |
Amendment |
5. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing, in the light of technical progress and considering the intended users or patients, the general safety and performance requirements set out in Annex I, including the information supplied by the manufacturer. |
deleted |
Amendment 96
Proposal for a regulation
Article 5 — paragraph 1
Text proposed by the Commission |
Amendment |
1. A device offered by means of information society services as defined in Article 1(2) of Directive 98/34/EC to a natural or legal person established in the Union shall comply with this Regulation at the latest when the device is placed on the market. |
1. A device offered by means of information society services as defined in Article 1(2) of Directive 98/34/EC to a natural or legal person established in the Union shall comply with this Regulation at the latest by the day on which the device is placed on the market. |
Amendment 97
Proposal for a regulation
Article 5 — paragraph 2 a (new)
Text proposed by the Commission |
Amendment |
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Amendment 98
Proposal for a regulation
Article 5 — paragraph 2 b (new)
Text proposed by the Commission |
Amendment |
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2b. There shall be a prohibition on the marketing, placing in use, distribution, delivery and making available of products whose names, labelling or instructions for use may mislead with regard to the product’s characteristics and effects by: |
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Promotional materials, presentations and information about the products may not mislead in the manner referred to in the first subparagraph. |
Amendment 99
Proposal for a regulation
Article 7 — paragraph 1
Text proposed by the Commission |
Amendment |
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficient , the Commission shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post-market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3). |
1. Where no harmonised standards exist or where there is a need to address public health concerns , the Commission, after having consulted the MDCG and the MDAC , shall be empowered to adopt common technical specifications (CTS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annex II or the clinical evaluation and post-market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3). |
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1a. Before adopting CTS referred to in paragraph 1, the Commission shall ensure that the CTS have been developed with the appropriate support of the relevant stakeholders and that they are coherent with the European and international standardisation system. CTS are coherent if they do not conflict with European standards, meaning they cover areas where no harmonised standards exist, the adoption of new European standards is not envisaged within a reasonable period, where existing standards have not gained market uptake or where those standards have become obsolete or have been demonstrated as clearly insufficient according to vigilance or surveillance data, and where the transposition of the technical specifications into European standardisation deliverables is not envisaged within a reasonable period. |
Amendment 100
Proposal for a regulation
Article 8 — paragraph 2 — subparagraph 2
Text proposed by the Commission |
Amendment |
The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing, in the light of technical progress, the elements in the technical documentation set out in Annex II. |
deleted |
Amendment 101
Proposal for a regulation
Article 8 — paragraph 6 — subparagraph 2
Text proposed by the Commission |
Amendment |
If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures. |
If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures , including immediate notification to Eudamed as established by Article 27 . |
Amendment 102
Proposal for a regulation
Article 8 — paragraph 8
Text proposed by the Commission |
Amendment |
8. Manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that product into conformity, withdraw it or recall it, as appropriate. They shall inform the distributors and, where applicable, the authorised representative accordingly. |
8. Manufacturers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that product into conformity, withdraw it or recall it, as appropriate. They shall inform the distributors , the importers and, where applicable, the authorised representative accordingly. |
Amendment 103
Proposal for a regulation
Article 8 — paragraph 9 — subparagraph 1 a (new)
Text proposed by the Commission |
Amendment |
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If a competent authority considers or has reason to believe that a device has caused damages, it shall ensure, where this is not already foreseen by national litigation or judicial proceedings, that the potentially harmed user, the user's successor in title, the user's health insurance company or other third parties affected by the damage caused to the user may request the information referred to in the first subparagraph from the manufacturer or his authorised representative while ensuring due respect to the intellectual property rights. |
Amendment 104
Proposal for a regulation
Article 8 — paragraph 10 a (new)
Text proposed by the Commission |
Amendment |
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10a. Before placing a medical device on the market, manufacturers shall ensure they are covered by an appropriate liability insurance covering any damages to patients or users that can be directly attributed to a manufacturing defect of the same medical device, with a level of coverage proportionate to the potential risk associated with the medical device produced, and in accordance with Council Directive 85/374/EEC (9) . |
Amendment 105
Proposal for a regulation
Article 11 — paragraph 2 — subparagraph 1 — point -a (new)
Text proposed by the Commission |
Amendment |
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Amendment 106
Proposal for a regulation
Article 11 — paragraph 2 — subparagraph 1 — point f a (new)
Text proposed by the Commission |
Amendment |
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Amendment 107
Proposal for a regulation
Article 11 — paragraph 7
Text proposed by the Commission |
Amendment |
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and his authorised representative and, if appropriate, take the necessary corrective action to bring that device into conformity, withdraw or recall it. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 45 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken . |
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and his authorised representative and, if appropriate, ensure that the necessary corrective action to bring that device in conformity, withdraw or recall it , is taken and, implement that action . Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 45 for the device in question, giving details, in particular, of the non-compliance and of any corrective action they have implemented . |
Amendment 108
Proposal for a regulation
Article 12 — paragraph 2 — subparagraph 1 — point c
Text proposed by the Commission |
Amendment |
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Amendment 109
Proposal for a regulation
Article 12 — paragraph 4
Text proposed by the Commission |
Amendment |
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non-compliance and of any corrective action taken. |
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure , within the scope of their respective activities, that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non-compliance and of any corrective action taken. |
Amendment 110
Proposal for a regulation
Article 13
Text proposed by the Commission |
Amendment |
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Person responsible for regulatory compliance |
Person responsible for regulatory compliance |
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1. Manufacturers shall have available within their organisation at least one qualified person who possesses expert knowledge in the field of medical devices. The expert knowledge shall be demonstrated by either of the following qualifications: |
1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications: |
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Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate their expert knowledge referred to in the first subparagraph by at least two years of professional experience within the relevant field of manufacture. |
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate their expert knowledge referred to in the first subparagraph by at least two years of professional experience within the relevant field of manufacture. |
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This paragraph shall not apply to manufacturers of custom-made devices who are micro-enterprises as defined by Commission Recommendation 2003/361/EC. |
This paragraph shall not apply to manufacturers of custom-made devices who are micro-enterprises as defined by Commission Recommendation 2003/361/EC. |
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2. The qualified person shall at least be responsible for ensuring the following matters: |
2. The person responsible for regulatory compliance shall at least be responsible for ensuring the following matters: |
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If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1 and 2, their respective areas of responsibility shall be stipulated in writing. |
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3. The qualified person shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his duties. |
3. The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his duties. |
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4. Authorised representatives shall have available within their organisation at least one qualified person who possesses expert knowledge regarding the regulatory requirements for medical devices in the Union. The expert knowledge shall be demonstrated by either of the following qualifications: |
4. Authorised representatives shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications: |
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Amendment 111
Proposal for a regulation
Article 14 — paragraph 1 — subparagraph 1 a (new)
Text proposed by the Commission |
Amendment |
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A distributor, importer or other natural or legal person shall assume the obligations incumbent on the manufacturer under paragraph 1(a) only if the device in question was manufactured outside the Union. In the case of devices manufactured within the Union, the manufacturer’s proof of compliance with this Regulation shall suffice. |
Amendment 112
Proposal for a regulation
Article 14 — paragraph 4
Text proposed by the Commission |
Amendment |
4. Prior to making the relabelled or repackaged device available, the distributor or importer referred to in paragraph 3 shall inform the manufacturer and the competent authority of the Member State where he plans to make the device available and, upon request, shall provide them with a sample or a mock-up of the relabelled or repackaged device, including any translated label and instructions for use. He shall submit to the competent authority a certificate, issued by a notified body referred to in Article 29, designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system complies with the requirements laid down in paragraph 3. |
4. At least 28 calendar days prior to making the relabelled or repackaged device available, the distributor or importer referred to in paragraph 3 shall inform the manufacturer and the competent authority of the Member State where he plans to make the device available and, upon request, shall provide them with a sample of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 calendar days, he shall submit to the competent authority a certificate, issued by a notified body referred to in Article 29, designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system complies with the requirements laid down in paragraph 3. |
Amendment 113
Proposal for a regulation
Article 15
Text proposed by the Commission |
Amendment |
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Article 15 |
deleted |
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Single-use devices and their reprocessing |
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1. Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation. |
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2. Only single-use devices that have been placed on the Union market in accordance with this Regulation, or prior to [date of application of this Regulation] in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed. |
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3. In the case of reprocessing of single-use devices for critical use, only reprocessing that is considered safe according to the latest scientific evidence may be carried out. |
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4. The Commission, by means of implementing acts, shall establish and regularly update a list of categories or groups of single-use devices for critical use which may be reprocessed in accordance with paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). |
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5. The name and address of the legal or natural person referred to in paragraph 1 and the other relevant information in accordance with Section 19 of Annex I shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device. |
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The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device. |
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6. A Member State may maintain or introduce national provisions prohibiting, within its territory, on grounds of protection of public health specific to that Member State the following: |
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Member States shall notify the Commission and the other Member States of the national provisions and the grounds for introducing them. The Commission shall keep the information publicly available. |
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Amendment 257
Proposal for a regulation
Chapter VI a (new)
Text proposed by the Commission |
Amendment |
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Chapter VIa (**) Labelling and safe reprocessing of medical devices |
Amendment 358
Proposal for a regulation
Article 15 a (new)
Text proposed by the Commission |
Amendment |
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Article 15a |
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General principles on safe reprocessing |
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1. Any natural or legal person, including health institutions as specified in Article 4(4), who wishes to reprocess a single-use device to make it suitable for further use within the Union, and who can provide scientific evidence that such a device could be safely reprocessed shall be considered to be the manufacturer of its reprocessed device and shall be held liable for its reprocessing activities. The natural or legal person shall ensure the traceability of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, with the exception of obligations linked to the conformity assessment procedure. |
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2. Only reusable devices that have been placed on the Union market in accordance with this Regulation, or prior to [date of application of this Regulation] in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed. |
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3. Unless they are placed on the list of single-use devices referred to in Article 15b, medical devices shall be considered as suitable for reprocessing and reusable devices in accordance with the provisions laid down in Article 15c, and providing the highest level of patient safety is guaranteed. |
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4. A Member State may maintain or introduce national provisions prohibiting, within its territory, on grounds of protection of public health specific to that Member State the following: |
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Member States shall notify the Commission and the other Member States of the national provisions and the grounds for introducing them. The Commission shall keep the information publicly available. |
Amendment 359
Proposal for a regulation
Article 15 b (new)
Text proposed by the Commission |
Amendment |
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Article 15b |
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List of single-use devices unsuitable for reprocessing |
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1. In accordance with Article 15a(3), the Commission, after the mandatory consultation of the MDAC shall establish, by means of delegated acts, a list of medical devices or types of medical device which are unsuitable for reprocessing. The Commission shall regularly update that list, including by adding or removing items. A first list shall be established no later than six months before the date of entry into force of this Regulation. |
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2. The decision to include or remove any device or type of device from the list shall be made in particular by taking into account: |
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3. The delegated acts referred to in paragraph 1 shall be adopted in accordance with Article 89. |
Amendment 118
Proposal for a regulation
Article 15 c (new)
Text proposed by the Commission |
Amendment |
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Article 15c |
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Reprocessing of medical devices labelled as reusable |
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1. Any natural or legal person, including health institutions as specified in Article 4(4), who reprocesses a device labelled as ‘reusable’ shall: |
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2. The Commission shall, by means of implementing acts, and in collaboration with the International Medical Devices Regulatory Forum and international standardisation bodies, define a clear set of high quality and safety standards for reprocessing of single use devices, including specific requirements for the manufacturers of reprocessed devices. |
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3. In drawing up these quality and safety standards, the Commission shall notably include: |
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These standards shall be consistent with the latest scientific evidence and guarantee the highest level of quality and safety, in accordance with the severity of the condition, as reflected in European standards from the European standardisation organisations, where the latter take into account the provisions of relevant international standards, in particular those of ISO and IEC, or any other international technical standards able to guarantee, at the very least, a higher level of quality, safety and performance than ISO and IEC standards. |
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3. The natural or legal person referred to in paragraph 1 shall comply with EU standards referred to in paragraph 1 to ensure the quality of the reprocessing of medical devices labelled as ‘reusable’ and the safety of reprocessed devices. |
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4. Where no harmonised standards exist or where relevant harmonised standards are not sufficient, the Commission shall be empowered to adopt CTS, as referred to in Article 7(1). |
Amendment 377
Proposal for a regulation
Article 15 d (new)
Text proposed by the Commission |
Amendment |
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Article 15d |
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Report on the functioning of the system |
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No later than four years after the date of application of this Regulation, the Commission shall assess and draw up an evaluation report. The report shall be submitted to the European Parliament and the Council. Where appropriate, the report shall be accompanied by a legislative proposal. |
Amendment 120
Proposal for a regulation
Article 16
Text proposed by the Commission |
Amendment |
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Implant card |
Implant card and information about implantable devices |
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1. The manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device. |
1. The manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the healthcare professional implanting the device who shall be responsible for: |
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The implant card shall also be made available by the manufacturer in an electronic format and Member States shall ensure that hospitals and clinics keep an electronic version on record. |
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The following implants shall be exempted from this obligation: sutures, staples, dentals implants, screws and plates. |
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The Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing this list of exempted implants. |
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2. This card shall contain the following: |
2. This card shall contain the following: |
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Member States may introduce national provisions requiring that the implant card includes also information on post-operative follow-up care measures. |
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The information shall be written in a way that is readily understood by a lay person. |
The information shall be written in a way that is readily understood by a lay person. |
Amendment 121
Proposal for a regulation
Article 21 — paragraph 1
Text proposed by the Commission |
Amendment |
1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device without significantly changing its performance or safety characteristics, shall ensure that the article does not adversely affect the safety and performance of the device. Substantiating evidence shall be kept available to the competent authorities of the Member States. |
1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device without changing its performance or safety characteristics, shall ensure that the article does not adversely affect the safety and performance of the device. When the article is a part of an implantable device, the natural or legal person who makes it available on the market shall cooperate with the manufacturer of the device to ensure its compatibility with the functioning part of the device in order to avoid the replacement of the whole device and its consequences for patient safety. Substantiating evidence shall be kept available to the competent authorities of the Member States. |
Amendment 122
Proposal for a regulation
Article 21 — paragraph 2
Text proposed by the Commission |
Amendment |
2. An article that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics of the device shall be considered a device. |
2. An article that is intended specifically to replace a part or component of a device and that changes the performance or safety characteristics of the device shall be considered as a device and shall meet the requirements laid down in this Regulation. |
Amendment 258
Proposal for a regulation
Chapter III — title
Text proposed by the Commission |
Amendment |
Identification and traceability of devices, registration of devices and of economic operators, European databank on medical devices |
Amendment 123
Proposal for a regulation
Article 24 — paragraph 1 — introductory part
Text proposed by the Commission |
Amendment |
1. For devices, other than custom-made and investigational devices, a system for Unique Device Identification shall be put in place in the Union. The UDI system shall allow the identification and traceability of devices and shall consist of the following: |
1. For devices, other than custom-made and investigational devices, a single system for Unique Device Identification (UDI) shall be put in place in the Union. The UDI system shall allow the identification and traceability of devices , be coherent if possible with the global regulatory approach for UDI in medical devices, and shall consist of the following: |
Amendment 124
Proposal for a regulation
Article 24 — paragraph 1 a (new)
Text proposed by the Commission |
Amendment |
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1a. The UDI system shall be updated with the results of the post-market clinical follow-up evaluation report referred to in Section 3 of Part B of Annex XIII. |
Amendment 125
Proposal for a regulation
Article 24 — paragraph 2 — point e — point i
Text proposed by the Commission |
Amendment |
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Amendment 126
Proposal for a regulation
Article 24 — paragraph 8 — point b
Text proposed by the Commission |
Amendment |
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Amendment 127
Proposal for a regulation
Article 24 — paragraph 8 — point e a (new)
Text proposed by the Commission |
Amendment |
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Amendment 128
Proposal for a regulation
Article 24 — paragraph 8 — point e b (new)
Text proposed by the Commission |
Amendment |
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Amendment 129
Proposal for a regulation
Article 25 — paragraph 2 — subparagraph 1 a (new)
Text proposed by the Commission |
Amendment |
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Steps shall be taken to ensure that no additional national registration procedures are necessary. |
Amendment 261
Proposal for a regulation
Chapter II a (new)
Text proposed by the Commission |
Amendment |
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Chapter IIa (****) Conformity assessment |
Amendment 130
Proposal for a regulation
Article 26
Text proposed by the Commission |
Amendment |
Summary of safety and clinical performance |
Safety and clinical performance report |
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance. It shall be written in a way that is clear to the intended user . The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 42 and shall be validated by that body. |
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a report on the safety and clinical performance of the device based on the full information collected during the clinical investigation. The manufacturer shall also draw up a summary of that report which shall be written in a way that is easy for a lay person to understand in the official language(s) of the country where the medical device is made available on the market . The draft report shall be part of the documentation to be submitted to and validated by the special notified body involved in the conformity assessment in accordance with Article 43a . |
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1a. The summary referred to in paragraph 1 shall be made available to the public through Eudamed in accordance with provisions under point (b) of Article 27(2) and point 18 of Annex V Part A. |
2. The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance . Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(2). |
2. The Commission may, by means of implementing acts, set out the format of the presentation of the data elements to be included in both the report and the summary referred to in paragraph 1 . Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(2). |
Amendment 131
Proposal for a regulation
Article 27
Text proposed by the Commission |
Amendment |
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1. The Commission shall develop and manage the European databank on medical devices (Eudamed) for the following purposes: |
1. The Commission shall develop, and manage the European databank on medical devices (Eudamed) for the following purposes: |
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2. Eudamed shall include the following as integral parts: |
2. Eudamed shall include the following as integral parts: |
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3. The data shall be entered into Eudamed by the Member States, notified bodies, economic operators and sponsors as specified in the provisions concerning the electronic systems referred to in paragraph 2. |
3. The data shall be entered into Eudamed by the Commission, the Member States, notified bodies, economic operators, sponsors and healthcare professionals as specified in the provisions concerning the electronic systems referred to in paragraph 2. |
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4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent defined in the provisions referred to in paragraph 2. |
4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors, healthcare professionals and the public to the extent defined in the provisions referred to in paragraph 2. |
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5. Eudamed shall contain personal data only insofar as this is necessary for the electronic systems referred to in paragraph 2 to collate and process the information in accordance with this Regulation. Personal data shall be kept in a form which permits identification of the data subjects for no longer than the periods referred to in Article 8(4). |
5. Eudamed shall contain personal data only insofar as this is necessary for the electronic systems referred to in paragraph 2 to collate and process the information in accordance with this Regulation. Personal data shall be kept in a form which permits identification of the data subjects for no longer than the periods referred to in Article 8(4). |
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6. The Commission and the Member States shall ensure that the data subjects may effectively exercise their rights to information, to access, to rectify and to object in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall ensure that the data subjects may effectively exercise the right of access to data relating to them, and the right to have inaccurate or incomplete data corrected and erased. Within their respective responsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data is deleted, in accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as possible, but no later than within 60 days after a request is made by a data subject. |
6. The Commission and the Member States shall ensure that the data subjects may effectively exercise their rights to information, to access, to rectify and to object in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall ensure that the data subjects may effectively exercise the right of access to data relating to them, and the right to have inaccurate or incomplete data corrected and erased. Within their respective responsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data is deleted, in accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as possible, but no later than within 60 days after a request is made by a data subject. |
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7. The Commission shall, by means of implementing acts, lay down the modalities necessary for the development and management of Eudamed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). |
7. The Commission shall, by means of implementing acts, lay down the modalities necessary for the development and management of Eudamed. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). |
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7a. The information contained in the European Databank shall be robust, transparent and user-friendly, enabling the public and healthcare professionals to compare information on registered devices, economic operators, clinical investigations, vigilance data and market-surveillance activities. |
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When developing and managing Eudamed, the Commission shall, in consultation with relevant stakeholders including patient and consumer organisations, ensure that all publicly accessible parts of Eudamed are presented in a user-friendly format. |
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8. In relation to its responsibilities under this Article and the processing of personal data involved therein, the Commission shall be considered controller of Eudamed and its electronic systems. |
8. In relation to its responsibilities under this Article and the processing of personal data involved therein, the Commission shall be considered controller of Eudamed and its electronic systems. |
Amendment 259
Proposal for a regulation
Chapter IV — title
Text proposed by the Commission |
Amendment |
Notified bodies |
Amendment 132
Proposal for a regulation
Article 28 — paragraphs 5 to 8
Text proposed by the Commission |
Amendment |
5. The national authority responsible for notified bodies shall safeguard the confidentiality of the information it obtains. However, it shall exchange information on a notified body with other Member States and the Commission. |
5. The national authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains. However, it shall exchange information on a notified body with other Member States and the Commission. |
6. The national authority responsible for notified bodies shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks. |
6. The national authority responsible for notified bodies shall have a sufficient number of permanent and competent personnel ‘in house’ , for the proper performance of its tasks. Compliance with that requirement shall be assessed in the peer-review referred to in paragraph 8. |
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In particular, the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out product related reviews shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3.2.5. of Annex VI. |
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Similarly, the personnel of the national authority responsible for auditing the work of personnel of notified bodies in charge of carrying out audits of the manufacturer's quality management system shall have proven qualifications equivalent to those of the personnel of the notified bodies as laid down in point 3.2.6. of Annex VI. |
Without prejudice to Article 33(3), where a national authority is responsible for the designation of notified bodies in the field of products other than medical devices, the competent authority for medical devices shall be consulted on all aspects specifically related to medical devices. |
Where a national authority is responsible for the designation of notified bodies in the field of products other than medical devices, the competent authority for medical devices shall be consulted on all aspects specifically related to medical devices. |
7. Member States shall provide the Commission and the other Member States with information on their procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto. |
7. The ultimate responsibility for the notified bodies and the national authority responsible for notified bodies lies with the Member State in which they are located. The Member State is required to check that the designated national authority responsible for notified bodies performs its work on the assessment, designation and notification of conformity assessment bodies and for the monitoring of the notified bodies properly and that the designated national authority responsible for notified bodies works impartially and objectively. Member States shall provide the Commission and the other Member States with all information they request on their procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and of any changes thereto. Such information shall be publicly available subject to provisions under Article 84. |
8. The national authority responsible for notified bodies shall be peer-reviewed every second year. The peer-review shall include an on-site visit to a conformity assessment body or a notified body under the responsibility of the reviewed authority. In the case referred to in the second subparagraph of paragraph 6, the competent authority for medical devices shall participate in the peer-review. |
8. The national authority responsible for notified bodies shall be peer-reviewed every second year. The peer-review shall include an on-site visit to a conformity assessment body or a notified body under the responsibility of the reviewed authority. In the case referred to in the second subparagraph of paragraph 6, the competent authority for medical devices shall participate in the peer-review. |
The Member States shall draw up the annual plan for the peer-review, ensuring an appropriate rotation in respect of reviewing and reviewed authorities, and submit it to the Commission. The Commission may participate in the review. The outcome of the peer-review shall be communicated to all Member States and to the Commission and a summary of the outcome shall be made publicly available. |
The Member States shall draw up the annual plan for the peer-review, ensuring an appropriate rotation in respect of reviewing and reviewed authorities, and submit it to the Commission. The Commission shall participate in the review. The outcome of the peer-review shall be communicated to all Member States and a summary of the outcome shall be made publicly available. |
Amendment 133
Proposal for a regulation
Article 29 — paragraph 1
Text proposed by the Commission |
Amendment |
1. Notified bodies shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this Regulation. Minimum requirements to be met by notified bodies are set out in Annex VI. |
1. Notified bodies shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil their tasks for which they are designated in accordance with this Regulation. In this respect, permanent in-house administrative, technical and scientific personnel, with medical, technical and where needed pharmacological knowledge shall be ensured. Permanent in-house personnel shall be used, but notified bodies may hire external experts on an ad hoc and temporary basis as and when needed. Minimum requirements to be met by notified bodies are set out in Annex VI. In particular, in accordance with point 1.2. of Annex VI, the notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities and avoid conflict of interests. |
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The notified body shall publish a list of its staff responsible for the conformity assessment and certification of medical devices. This list shall at least contain the qualifications, curriculum vitae and declaration of interests for each member of staff. The list shall be sent to the national authority responsible for notified bodies which shall check that the staff satisfies the requirements of this Regulation. The list shall also be sent to the Commission. |
Amendment 134
Proposal for a regulation
Article 30
Text proposed by the Commission |
Amendment |
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-1. Notified bodies shall have permanent in-house competent personnel and expertise, both in technical fields linked with the assessment of the performance of the devices, and in the medical field. They shall have the capacity to evaluate in house the quality of subcontractors. |
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Contracts may be awarded to external experts for the assessment of medical devices or technologies in particular where clinical expertise is limited. |
1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the relevant requirements set out in Annex VI and shall inform the national authority responsible for notified bodies accordingly. |
1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the relevant requirements set out in Annex VI and shall inform the national authority responsible for notified bodies accordingly. |
2. Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries. |
2. Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries. |
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2a. Notified bodies shall make publicly available the list of subcontractors or subsidiaries, the specific tasks for which they are responsible and the declarations of interest of their personnel. |
3. Conformity assessment activities may be subcontracted or carried out by a subsidiary only with the agreement of the legal or natural person that applied for conformity assessment. |
3. Conformity assessment activities may be subcontracted or carried out by a subsidiary only with the explicit agreement of the legal or natural person that applied for conformity assessment. |
4. Notified bodies shall keep at the disposal of the national authority responsible for notified bodies the relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation. |
4. At least once a year , notified bodies shall submit to the national authority responsible for notified bodies the relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation. |
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4a. The annual assessment of notified bodies as provided for in Article 35(3) shall include verification of the compliance of the subcontractor(s) or the subsidiary/ies of notified bodies with the requirements set out in Annex VI. |
Amendment 135
Proposal for a regulation
Article 30 a (new)
Text proposed by the Commission |
Amendment |
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Article 30a |
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Electronic system on registration of subsidiaries and subcontractors |
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1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process information on subcontractors and subsidiaries, as well as on the specific tasks for which they are responsible. |
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2. Before subcontracting can effectively take place, the notified body which intends to subcontract specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, shall register their name(s) together with their specific tasks. |
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3. Within one week of any change occurring in relation to the information referred to in paragraph 1, the relevant economic operator shall update the data in the electronic system. |
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4. The data contained in the electronic system shall be accessible to the public. |
Amendment 136
Proposal for a regulation
Article 31 — paragraph 1 — subparagraph 1 a (new)
Text proposed by the Commission |
Amendment |
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In case a conformity assessment body wants to be notified for devices referred to in Article 43a(1), it shall indicate so and submit an application for notification to the EMA in accordance with Article 43a. |
Amendment 137
Proposal for a regulation
Article 32 — paragraphs 3 to 6
Text proposed by the Commission |
Amendment |
3. Within 14 days of the submission referred to in paragraph 2, the Commission shall designate a joint assessment team made up of at least two experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies. The list shall be drawn up by the Commission in cooperation with the MDCG. At least one of these experts shall be a representative of the Commission who shall lead the joint assessment team. |
3. Within 14 days of the submission referred to in paragraph 2, the Commission shall designate a joint assessment team made up of at least three experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies and free of conflicts of interest with the applicant conformity assessment body. The list shall be drawn up by the Commission in cooperation with the MDCG. At least one of these experts shall be a representative of the Commission, and at least one other shall come from a Member State other than the one in which the applicant conformity assessment body is established. The Commission representative shall lead the joint assessment team. In case the conformity assessment body has asked to be notified for devices referred to in Article 43a(1), the EMA shall also be part of the joint assessment team. |
4. Within 90 days after designation of the joint assessment team, the national authority responsible for notified bodies and the joint assessment team shall review the documentation submitted with the application in accordance with Article 31 and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or sub-contractor, located inside or outside the Union, to be involved in the conformity assessment process. Such on-site assessment shall not cover requirements for which the applicant conformity assessment body has received a certificate delivered by the national accreditation body as referred to in Article 31(2), unless the Commission representative mentioned in Article 32(3) requests the on-site assessment. |
4. Within 90 days after designation of the joint assessment team, the national authority responsible for notified bodies and the joint assessment team shall review the documentation submitted with the application in accordance with Article 31 and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or sub-contractor, located inside or outside the Union, to be involved in the conformity assessment process. Such on-site assessment shall not cover requirements for which the applicant conformity assessment body has received a certificate delivered by the national accreditation body as referred to in Article 31(2), unless the Commission representative mentioned in Article 32(3) requests the on-site assessment. |
Findings regarding non-compliance of a body with the requirements set out in Annex VI shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team with a view to finding common agreement with respect to the assessment of the application. Divergent opinions shall be identified in the assessment report of the national authority responsible. |
Findings regarding non-compliance of a n applicant conformity assessment body with the requirements set out in Annex VI shall be raised during the assessment process and discussed between the national authority responsible for notified bodies and the joint assessment team. The national authority shall set out in the assessment report the measures that the notify body shall take to ensure compliance of that applicant conformity assessment body with the requirements set out in Annex VI. In the event of a disagreement, a separate opinion drawn up by the assessment team setting out its reservations regarding notification shall be appended to the assessment report of the national authority responsible. |
5. The national authority responsible for notified bodies shall submit its assessment report and its draft notification to the Commission which shall immediately transmit those documents to the MDCG and to the members of the joint assessment team. Upon request by the Commission, those documents shall be submitted by the authority in up to three official Union languages. |
5. The national authority responsible for notified bodies shall submit its assessment report and its draft notification to the Commission which shall immediately transmit those documents to the MDCG and to the members of the joint assessment team. If the assessment team draws up a separate opinion, this too shall be submitted to the Commission for forwarding to the MDCG. Upon request by the Commission, those documents shall be submitted by the authority in up to three official Union languages. |
6. The joint assessment team shall provide its opinion regarding the assessment report and the draft notification within 21 days of receipt of those documents and the Commission shall immediately submit this opinion to the MDCG. Within 21 days after receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft notification which the relevant national authority shall duly take into consideration for its decision on the designation of the notified body. |
6. The joint assessment team shall provide its final opinion regarding the assessment report, the draft notification and, where appropriate, the separate opinion drawn up by the assessment team, within 21 days of receipt of those documents and the Commission shall immediately submit this opinion to the MDCG. Within 21 days after receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft notification . The relevant national authority shall base its decision on the designation of the notified body on the recommendation by the MDCG. In case where its decision differs from the MDCG recommendation, the relevant national authority shall provide the MDCG in writing with all the necessary justification for its decision. |
Amendment 138
Proposal for a regulation
Article 33 — paragraphs 2 to 4 and 8 to 9
Text proposed by the Commission |
Amendment |
2. Member States may notify only conformity assessment bodies which satisfy the requirements set out in Annex VI. |
2. Member States shall notify only conformity assessment bodies which satisfy the requirements set out in Annex VI and for which the application assessment procedure has been completed in accordance with Article 32. |
3. Where a national authority responsible for notified bodies is responsible for designation of notified bodies in the field of products other than medical devices, the competent authority for medical devices shall provide, prior to the notification, a positive opinion on the notification and its scope. |
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4. The notification shall clearly specify the scope of the designation indicating the conformity assessment activities, the conformity assessment procedures and the type of devices which the notified body is authorised to assess. |
4. The notification shall clearly specify the scope of the designation indicating the conformity assessment activities, the conformity assessment procedures, the risk class and the type of devices which the notified body is authorised to assess. |
The Commission may, by means of implementing acts, set up a list of codes and the corresponding types of devices to define the scope of the designation of notified bodies which the Member States shall indicate in their notification. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(2). |
The Commission may, by means of implementing acts, set up a list of codes and the corresponding risk-classes and types of devices to define the scope of the designation of notified bodies which the Member States shall indicate in their notification. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 88(2). |
8. When a Member State or the Commission raises objections in accordance with paragraph 7, the effect of the notification shall be suspended. In this case, the Commission shall bring the matter before the MDCG within 15 days after expiry of the period referred to in paragraph 7. After consulting the parties involved, the MDCG shall give its opinion at the latest within 28 days after the matter has been brought before it. If the notifying Member State does not agree with the opinion of the MDCG, it may request the Commission to give its opinion. |
8. When a Member State or the Commission raises objections in accordance with paragraph 7, the effect of the notification shall be immediately suspended. In this case, the Commission shall bring the matter before the MDCG within 15 days after expiry of the period referred to in paragraph 7. After consulting the parties involved, the MDCG shall give its opinion at the latest within 28 days after the matter has been brought before it. If the notifying Member State does not agree with the opinion of the MDCG, it may request the Commission to give its opinion. |
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially , the Commission shall publish the notification accordingly. |
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully, the Commission shall publish the notification accordingly. |
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The Commission shall also enter information on the notification of the notified body into the electronic system referred to in Article 27(2). That information shall be accompanied by the final assessment report of the national authority responsible for notified bodies, the opinion of the joint assessment team and the recommendation of the MDCG, as referred to in this article. |
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The full details of the notification, including the class and the typology of devices, as well as the annexes, shall be made publicly available. |
Amendment 139
Proposal for a regulation
Article 34 — paragraph 1
Text proposed by the Commission |
Amendment |
1. The Commission shall assign an identification number to each notified body for which the notification is accepted in accordance with Article 33. It shall assign a single identification number even when the body is notified under several Union acts. |
1. The Commission shall assign an identification number to each notified body for which the notification is accepted in accordance with Article 33. It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully renotified, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to them. |
Amendment 140
Proposal for a regulation
Article 34 — paragraph 2
Text proposed by the Commission |
Amendment |
2. The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified, accessible to the public. The Commission shall ensure that the list is kept up to date. |
2. The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified, easily accessible to the public. The Commission shall ensure that the list is kept up to date |
Amendment 141
Proposal for a regulation
Article 35
Text proposed by the Commission |
Amendment |
1. The national authority responsible for notified bodies shall continuously monitor the notified bodies to ensure ongoing compliance with the requirements set out in Annex VI. The notified bodies shall, on request, supply all relevant information and documents, required to enable the authority to verify compliance with those criteria. |
1. The national authority responsible for notified bodies , and where applicable the EMA, shall continuously monitor the notified bodies to ensure ongoing compliance with the requirements set out in Annex VI. The notified bodies shall, on request, supply all relevant information and documents, required to enable the authority to verify compliance with those criteria. |
Notified bodies shall, without delay, inform the national authority responsible for notified bodies of any changes, in particular regarding their personnel, facilities, subsidiaries or subcontractors, which may affect compliance with the requirements set out in Annex VI or their ability to conduct the conformity assessment procedures relating to the devices for which they have been designated. |
Notified bodies shall, without delay, and within 15 days at the latest, inform the national authority responsible for notified bodies of any changes, in particular regarding their personnel, facilities, subsidiaries or subcontractors, which may affect compliance with the requirements set out in Annex VI or their ability to conduct the conformity assessment procedures relating to the devices for which they have been designated. |
2. Notified bodies shall respond without delay to requests relating to conformity assessments they have carried out, submitted by their or another Member State's authority or by the Commission. The national authority responsible for notified bodies of the Member State in which the body is established shall enforce requests submitted by authorities of any other Member State or by the Commission unless there is a legitimate reason for not doing so in which case both sides may consult the MDCG. The notified body or their national authority responsible for notified bodies may request that any information transmitted to the authorities of another Member State or to the Commission shall be treated confidential. |
2. Notified bodies shall respond without delay, and within 15 days at the latest, to requests relating to conformity assessments they have carried out, submitted by their or another Member State's authority or by the Commission. The national authority responsible for notified bodies of the Member State in which the body is established shall enforce requests submitted by authorities of any other Member State or by the Commission. Where there is a legitimate reason for not doing so, the notified bodies shall explain these reasons in writing and shall consult the MDCG , which shall then issue a recommendation. The national authority responsible for notified bodies shall comply with the MDCG's recommendation. |
3. At least once a year, the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in Annex VI. This assessment shall include an on-site visit to each notified body. |
3. At least once a year, the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in Annex VI , including an assessment of whether its subcontractor(s) and subsidiary/-ies satisfy these requirements. This assessment shall include an unannounced inspection through an on-site visit to each notified body , and to each subsidiary or subcontractor within or outside the Union, if relevant . |
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The assessment shall also include a review of samples of the design dossier assessments carried out by the notified body to determine the ongoing competence of the notified body and quality of its assessments, in particular the notified body's ability to evaluate and assess clinical evidence. |
4. Three years after notification of a notified body, and again every third year thereafter, the assessment to determine whether the notified body still satisfies the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established and a joint assessment team designated in accordance with the procedure described in Article 32(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body with the requirements set out in Annex VI. |
4. Two years after notification of a notified body, and again every second year thereafter, the assessment to determine whether the notified body and its subsidiaries and subcontractors still satisfy the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established and a joint assessment team designated in accordance with the procedure described in Article 32(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body, or a subsidiary or subcontractor of a notified body, with the requirements set out in Annex VI. |
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For special notified bodies under Article 43a, the assessment referred to in this paragraph shall be performed every year. |
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The comprehensive results of the assessments shall be published. |
5. The Member States shall report to the Commission and to the other Member States, at least once a year, on their monitoring activities. This report shall contain a summary which shall be made publicly available. |
5. The Member States shall report to the Commission and to the other Member States, at least once a year, on their monitoring activities. This report shall contain a summary which shall be made publicly available. |
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5a. Every year, the notified bodies shall forward an annual activity report setting out the information referred to in point 3.5 of Annex VI to the competent authority and to the Commission, which shall forward it to the MDCG. |
Amendment 142
Proposal for a regulation
Article 35 a (new)
Text proposed by the Commission |
Amendment |
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Article 35a |
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Penalties |
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Member States shall ensure they have a system of penalties in place in case notified bodies do not fulfil the minimum requirements. This system should be transparent and proportionate to the nature and level of the non-compliance. |
Amendment 143
Proposal for a regulation
Article 36
Text proposed by the Commission |
Amendment |
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1. The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification. The procedures described in Article 32(2) to (6) and in Article 33 shall apply to changes where they entail an extension of the scope of the notification. In all other cases, the Commission shall immediately publish the amended notification in the electronic notification tool referred to in Article 33(10). |
1. The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification. The procedures described in Article 32(2) to (6) and in Article 33 shall apply to changes where they entail an extension of the scope of the notification. In all other cases, the Commission shall immediately publish the amended notification in the electronic notification tool referred to in Article 33(10). |
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2. Where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VI, or that it is failing to fulfil its obligations, the authority shall suspend, restrict, or fully or partially withdraw the notification, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period . Where the notified body has ceased its activity, the national authority responsible for notified bodies shall withdraw the notification. |
2. Where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VI, or that it is failing to fulfil its obligations, the authority shall suspend, restrict, or fully or partially withdraw the notification, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. Suspension shall apply until a decision to annul the suspension has been reached by the MDCG, which shall follow an assessment by a joint assessment team designated in accordance with the procedure described in Article 32(3). Where the notified body has ceased its activity, the national authority responsible for notified bodies shall withdraw the notification. |
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The national authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a notification. |
The national authority responsible for notified bodies shall immediately and within 10 days at the latest, inform the Commission, the other Member States and the relevant manufacturers and health professionals of any suspension, restriction or withdrawal of a notification. |
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3. In the event of restriction, suspension or withdrawal of a notification, the Member State shall take appropriate steps to ensure that the files of the notified body concerned are either processed by another notified body or kept available for the national authorities responsible for notified bodies and for market surveillance at their request. |
3. In the event of restriction, suspension or withdrawal of a notification, the Member State shall inform the Commission and shall take appropriate steps to ensure that the files of the notified body concerned are either processed by another notified body or kept available for the national authorities responsible for notified bodies and for market surveillance at their request. |
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4. The national authority responsible for notified bodies shall assess whether the reasons which gave rise to the change to the notification have an impact on the certificates issued by the notified body and, within three months after having notified the changes to the notification, shall submit a report on its findings to the Commission and the other Member States. Where necessary to ensure the safety of devices on the market, that authority shall instruct the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued. If the notified body fails to do so within the determined period of time, or has ceased its activity, the national authority responsible for notified bodies itself shall suspend or withdraw the certificates unduly issued. |
4. The national authority responsible for notified bodies shall assess whether the reasons which gave rise to the suspension, restriction or withdrawal of the notification have an impact on the certificates issued by the notified body and, within three months after having notified the changes to the notification, shall submit a report on its findings to the Commission and the other Member States. Where necessary to ensure the safety of devices on the market, that authority shall instruct the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, and at the latest 30 days after the publication of the report, any certificates which were unduly issued. If the notified body fails to do so within the determined period of time, or has ceased its activity, the national authority responsible for notified bodies itself shall suspend or withdraw the certificates unduly issued. |
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With a view to verifying whether the reasons for the suspension, restriction or withdrawal of the notification have implications for the certificates issued, the national authority responsible shall ask the relevant manufacturers to supply evidence of conformity at notification, and the manufacturers shall have 30 days in which to respond to that request. |
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5. The certificates, other than those unduly issued, which were issued by the notified body for which the notification has been suspended, restricted or withdrawn shall remain valid in the following circumstances: |
5. The certificates, other than those unduly issued, which were issued by the notified body for which the notification has been suspended, restricted or withdrawn shall remain valid in the following circumstances: |
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The authority or the notified body assuming the functions of the notified body affected by the change of notification shall immediately inform the Commission, the other Member States and the other notified bodies thereof. |
The authority or the notified body assuming the functions of the notified body affected by the change of notification shall immediately and within 10 days at the latest, inform the Commission, the other Member States and the other notified bodies thereof. |
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The Commission shall immediately and within 10 days at the latest enter information on the changes to the notification of the notified body into the electronic system referred to in Article 27(2). |
Amendment 144
Proposal for a regulation
Article 37 — paragraph 3 — subparagraph 1
Text proposed by the Commission |
Amendment |
Where the Commission ascertains that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification if necessary. |
Where the Commission ascertains that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification if necessary. The Commission shall make a report with the opinions of Member States publicly available after the assessment. |
Amendment 145
Proposal for a regulation
Article 39 — paragraph 1
Text proposed by the Commission |
Amendment |
The Commission shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. |
The Commission , in consultation with the MDCG, shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices. This group shall meet on a regular basis and at least twice a year. |
Amendment 146
Proposal for a regulation
Article 39 — paragraph 2 a (new)
Text proposed by the Commission |
Amendment |
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The Commission or the MDCG may request the participation of any notified body. |
Amendment 147
Proposal for a regulation
Article 39 — paragraph 2 b (new)
Text proposed by the Commission |
Amendment |
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The Commission may, by means of implementing acts, adopt measures setting out the modalities for the functioning of the coordination group of notified bodies as set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3). |
Amendment 148
Proposal for a regulation
Article 40
Text proposed by the Commission |
Amendment |
Fees |
Fees for the activities of national authorities |
1. The Member State where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation. |
1. The Member State where the bodies are established shall levy fees on applicant conformity assessment bodies and on notified bodies. These fees shall, wholly or partly, cover the costs relating to the activities exercised by the national authorities responsible for notified bodies in accordance with this Regulation. |
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 setting out the structure and the level of the fees referred to in paragraph 1, taking into account the objectives of protection of human health and safety, support of innovation and cost-effectiveness. Particular attention shall be paid to the interests of notified bodies that submitted a valid certificate delivered by the national accreditation body as referred to in Article 31(2) and notified bodies that are small and medium-sized enterprises as defined by Commission Recommendation 2003/361/EC. |
2. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 setting out the structure and the level of the fees referred to in paragraph 1, taking into account the objectives of protection of human health and safety, support of innovation, cost-effectiveness and the need to create a level-playing field across Member States. Particular attention shall be paid to the interests of notified bodies that submitted a valid certificate delivered by the national accreditation body as referred to in Article 31(2) and notified bodies that are small and medium-sized enterprises as defined by Commission Recommendation 2003/361/EC. |
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These fees shall be proportionate and consistent with national standards of living. The level of fees shall be made public. |
Amendment 149
Proposal for a regulation
Article 40 a (new)
Text proposed by the Commission |
Amendment |
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Article 40 a |
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Transparency on fees charged by notified bodies for conformity assessment activities |
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1. Member States shall adopt provisions on standard fees for notified bodies. |
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2. Fees shall be comparable across Member States. The Commission shall provide guidelines to facilitate comparability of those fees within 24 months from the date of entry into force of this Regulation. |
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3. Member States shall transmit their list of standard fees to the Commission. |
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4. The national authority shall ensure that the notified bodies make the lists of standard fees for the conformity assessment activities publicly available. |
Amendment 260
Proposal for a regulation
Chapter V — title
Text proposed by the Commission |
Amendment |
Classification of medical devices |
Amendment 150
Proposal for a regulation
Article 41 — paragraph 2 — subparagraph 2
Text proposed by the Commission |
Amendment |
At least 14 days prior to any decision, the competent authority shall notify the MDCG and the Commission of its envisaged decision. |
At least 14 days prior to any decision, the competent authority shall notify the MDCG and the Commission of its envisaged decision. The final decision shall be made publically available in the Eudamed. |
Amendment 151
Proposal for a regulation
Article 41 — paragraph 3 — subparagraph 1
Text proposed by the Commission |
Amendment |
The Commission may, at the request of a Member State or on its own initiative, by means of implementing acts, decide on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices, with a view to determining their classification. |
The Commission may, at the request of a Member State or on its own initiative, by means of implementing acts, decide on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices, with a view to determining their classification. Such decision should in particular be taken in order to resolve diverging decisions between Member States. |
Amendment 152
Proposal for a regulation
Article 41 — paragraph 3 — subparagraph 2
Text proposed by the Commission |
Amendment |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). |
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). Before adopting implementing acts, the Commission shall consult with relevant stakeholders and take into account their suggestions. |
Amendment 153
Proposal for a regulation
Article 41 — paragraph 4 — introductory part
Text proposed by the Commission |
Amendment |
4. In the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 as regards the following: |
4. In the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission , having consulted relevant stakeholders, including organisations of healthcare professionals, shall be empowered to adopt delegated acts in accordance with Article 89 as regards the following: |
Amendment 154
Proposal for a regulation
Article 42 — paragraph 4
Text proposed by the Commission |
Amendment |
4. Manufacturers of devices classified as class IIa, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance as specified in Annex VIII, except for its Chapter II, with assessment of the design documentation within the technical documentation on a representative basis. Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annex II coupled with a conformity assessment based on product conformity verification as specified in Section 7 of Part A or Section 8 of Part B of Annex X. |
4. Manufacturers of devices classified as class IIa, other than custom-made or investigational devices, shall be subject to a conformity assessment based on full quality assurance as specified in Annex VIII, except for its Chapter II, with assessment of the prototype and the design documentation within the technical documentation on a representative basis. Alternatively, the manufacturer may choose to draw up the technical documentation set out in Annex II coupled with a conformity assessment based on product conformity verification as specified in Section 7 of Part A or Section 8 of Part B of Annex X. |
Amendment 155
Proposal for a regulation
Article 42 — paragraph 10 — subparagraph 1 — introductory part
Text proposed by the Commission |
Amendment |
The Commission may , by means of implementing acts, specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects: |
The Commission shall , by means of implementing acts, specify the modalities and the procedural aspects with a view to ensuring harmonised application of the conformity assessment procedures by the notified bodies for any of the following aspects: |
Amendment 156
Proposal for a regulation
Article 42 — paragraph 10 — subparagraph 1 — indent 2
Text proposed by the Commission |
Amendment |
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deleted |
Amendment 157
Proposal for a regulation
Article 42 — paragraph 10 a (new)
Text proposed by the Commission |
Amendment |
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10a. Unannounced inspections, in terms of their nature and extent, may be counted as regular inspections, with offsetting of economic operators’ costs resulting from unannounced inspections, provided that no significant non-conformities are recorded during unannounced inspections. Account must be taken at all times, when ordering unannounced inspections and carrying them out, of the proportionality principle, with due regard, in particular, for the risk potential of each individual product. |
Amendment 158
Proposal for a regulation
Article 42 — paragraph 11
Text proposed by the Commission |
Amendment |
11. In the light of technical progress and any information which becomes available in the course of the designation or monitoring of notified bodies set out in Articles 28 to 40, or of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the conformity assessment procedures set out in Annexes VIII to XI. |
deleted |
Amendment 159
Proposal for a regulation
Article 43 — title and paragraph 1
Text proposed by the Commission |
Amendment |
Involvement of notified bodies |
Involvement of notified bodies in conformity assessment procedures |
1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of his choice, provided that the body is notified for the conformity assessment activities, the conformity assessment procedures and the devices concerned. An application may not be lodged in parallel with more than one notified body for the same conformity assessment activity. |
1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer of devices other than those listed in Article 43a(1) may apply to a notified body of his choice, provided that the body is notified for the conformity assessment activities, the conformity assessment procedures and the devices concerned. Where a manufacturer applies to a notified body located in a Member State other than the one where it is registered, the manufacturer shall inform its national authority responsible for the notified bodies of the application. An application may not be lodged in parallel with more than one notified body for the same conformity assessment activity. |
Amendment 160
Proposal for a regulation
Article 43 — paragraph 2
Text proposed by the Commission |
Amendment |
2. The notified body concerned shall inform the other notified bodies of any manufacturer who withdraws his application prior to the notified body's decision regarding the conformity assessment. |
2. The notified body concerned shall inform the other notified bodies of any manufacturer who withdraws his application prior to the notified body's decision regarding the conformity assessment. It shall also inform all of the competent national bodies without delay. |
Amendment 161
Proposal for a regulation
Chapter V — Section 2 a (new) — title (new)
Text proposed by the Commission |
Amendment |
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Amendments 360 and 371
Proposal for a regulation
Article 43 a (new)
Text proposed by the Commission |
Amendment |
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Article 43a |
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Involvement of the special notified bodies in the conformity assessment procedures of high-risk devices |
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1. Only special notified bodies shall be entitled to conduct conformity assessments for the following devices: |
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2. Applicant special notified bodies which consider they fulfil the requirements for special notified bodies referred to in Annex VI, point 3.6, shall submit their application to the EMA. |
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3. The application shall be accompanied by the fee payable to the EMA to cover the costs relating to the examination of the application. |
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4. The EMA shall designate the special notified body or bodies in accordance with requirements listed in Annex VI, and adopt its opinion on the authorisation to perform conformity assessments for devices listed in paragraph 1 within 90 days and send it to the Commission. |
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5. The Commission shall then publish the notification accordingly and the name of the special notified body or bodies. |
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6. This notification shall become valid the day after its publication in the database of notified bodies developed and managed by the Commission. The published notification shall determine the scope of lawful activity of the special notified body. |
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This notification shall be valid for five years and subject to renewal every five years, following a new application to the EMA. |
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7. The manufacturer of devices listed in paragraph 1 may apply to a special notified body of his choice, whose name appears in the electronic system of Article 43b (new). |
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8. An application may not be lodged in parallel with more than one special notified body for the same conformity assessment activity. |
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9. The special notified body shall notify the Commission of applications for conformity assessments for devices listed in paragraph 1. |
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10. Article 43 (2), (3) and (4) apply to special notified bodies. |
Amendment 372
Proposal for a regulation
Article 43 b (new)
Text proposed by the Commission |
Amendment |
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Article 43b |
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Electronic system on special notified bodies |
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1. The Commission shall establish and regularly update an electronic registration system for: |
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2. The information collated and processed in the electronic system which relates to the application process for special notified bodies shall be entered into the electronic registration system by the EMA. |
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3. The information collated and processed in the electronic system and which relates to special notified bodies shall be accessible to the public. |
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4. The Commission shall regularly update the system. |
Amendments 361 and 373
Proposal for a regulation
Article 43 c (new)
Text proposed by the Commission |
Amendment |
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Article 43c |
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Network of special notified bodies |
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1. The Commission and the MDCG shall establish, host, coordinate and manage the network of special notified bodies. |
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2. The network shall have the following objectives: |
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3. Meetings of the network shall be convened whenever requested by at least two of its members or by the EMA. It shall meet at least twice a year. |
Amendment 165
Proposal for a regulation
Article 44
Text proposed by the Commission |
Amendment |
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Article 44 |
deleted |
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Mechanism for scrutiny of certain conformity assessments |
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1. Notified bodies shall notify the Commission of applications for conformity assessments for devices classified as class III, with the exception of applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG. |
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2. Within 28 days of receipt of the information referred to in paragraph 1, the MDCG may request the notified body to submit a summary of the preliminary conformity assessment prior to issuing a certificate. Upon suggestion by any of its members or by the Commission, the MDCG shall decide on making such request in accordance with the procedure set out in Article 78(4). In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file for submission of a summary of the preliminary conformity assessment. When selecting a specific file for submission, the principle of equal treatment shall be duly taken into account. |
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Within 5 days after receipt of the request by the MDCG, the notified body shall inform the manufacturer thereof. |
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3. The MDCG may submit comments on the summary of the preliminary conformity assessment at the latest 60 days after submission of this summary. Within that period and at the latest 30 days after submission, the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the notified body's preliminary conformity assessment. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this subparagraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments. |
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4. The notified body shall give due consideration to any comments received in accordance with paragraph 3. It shall convey to the Commission an explanation of how they have been taken into consideration, including any due justification for not following the comments received, and its final decision regarding the conformity assessment in question. The Commission shall immediately transmit this information to the MDCG. |
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5. Where deemed necessary for the protection of patient safety and public health, the Commission, may determine, by means of implementing acts, specific categories or groups of devices, other than devices of class III, to which paragraphs 1 to 4 shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). |
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Measures pursuant to this paragraph may be justified only by one or more of the following criteria: |
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6. The Commission shall make a summary of the comments submitted in accordance with paragraph 3 and the outcome of the conformity assessment procedure accessible to the public. It shall not disclose any personal data or information of commercially confidential nature. |
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7. The Commission shall set up the technical infrastructure for the data-exchange by an electronic means between notified bodies and MDCG for the purposes of this Article. |
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8. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the summary of the preliminary conformity assessment in accordance with paragraphs 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). |
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Amendment 374/REV
Proposal for a regulation
Article 44 a (new)
Text proposed by the Commission |
Amendment |
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Article 44a |
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Assessment procedure in specific cases |
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1. Special notified bodies shall notify the Commission of applications for conformity assessments for implantable Class III devices, Class IIb devices intended to administer and/or remove a medicinal product, as referred to in Article 1(5) and point 5.3. of Annex VII (Rule 11), and devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or are rendered non-viable with the exception of applications to renew or supplement existing certificates and devices for which specifications referred to in Articles 6 and 7 have been published for the clinical evaluation and the post-market clinical follow-up. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification the special notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the Medical Device Coordination Group (MDCG) for an opinion. In making its opinion, the MDCG may seek a clinical assessment from the relevant experts of the Assessment Committee for Medical Devices (ACMD), referred to in Article 78. |
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2. Within 20 days of receipt of the information referred to in paragraph 1, the MDCG may decide to request the special notified body to submit the following documents prior to issuing a certificate: |
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The members of the MDCG shall decide on making such a request only on the basis of the following criteria: |
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In the light of technical progress and any information which becomes available, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing these criteria. |
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In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file. |
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In the absence of request from the MDCG within 20 days of receipt of the information referred to in paragraph 1, the special notified body may continue with the conformity assessment procedure. |
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3. The MDCG, following the consultation of the ACMD shall issue a MDCG opinion on the documents referred to in paragraph 2 at the latest 60 days after its submission. Within that period and at the latest 30 days after submission, the ACMD through the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the documents referred to in paragraph 2. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this paragraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments. |
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4. In its opinion the MDCG shall take into account the clinical assessment of the ACMD. The MDCG may recommend modifications of the documents referred to in paragraph 2. |
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5. The MDCG shall immediately inform the Commission, the special notified body and the manufacturer of its opinion. |
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6. Within 15 days after receipt of the opinion referred to in paragraph 5, the special notified body shall indicate whether or not it agrees with the opinion of the MDCG. In the latter case, it may give written notice to the MDCG. that it wishes to request a re-examination of the opinion. In that case, the special notified body shall forward to the MDCG the detailed grounds for the request within 30 days after receipt of the opinion. The MDCG shall immediately transmit this information to the ACMD and the Commission. |
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Within 30 days following receipt of the grounds for the request, the MCDG shall re-examine its opinion, after consultation of the ACMD where necessary. The reasons for the conclusion reached shall be annexed to the final opinion. |
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7. Immediately after its adoption, the MCDG shall send its final opinion to the Commission, the special notified body and the manufacturer. |
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8. In the case of a favourable opinion MDCG opinion, the special notified body may proceed with the certification. |
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However if the favourable MDCG opinion is dependent on the application of specific measures (e.g. adaptation of the post-market clinical follow-up plan, certification with a time limit), the special notified body shall issue the certificate of conformity only on the conditions that those measures are fully implemented. |
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Following the adoption of a favourable opinion, the Commission shall always explore the possibility of adopting, common technical standards for the device of group of devices concerned and adopt them where possible (in accordance with Article 7). |
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In the case of an unfavourable MDCG opinion, the special notified body shall not yet deliver the certificate of conformity. Nevertheless, the special notified body may submit new information in response to the explanation included in the MDCG assessment. If the new information is substantially different to that which has been previously submitted the MDCG shall reassess the application. |
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At the request of the manufacturer, the Commission shall organise a hearing allowing discussion on the scientific grounds for the unfavourable scientific assessment and any action that the manufacturer may take or data that may be submitted to address the MDCG concerns. |
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9. Where deemed necessary for the protection of patient safety and public health, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 to determine, specific categories or groups of devices, other than devices referred to in paragraph 1, to which paragraphs 1 to 8 shall apply during a predefined period of time. |
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Measures pursuant to this paragraph may be justified only by one or more of the criteria referred to in paragraph 2. |
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10. The Commission shall make a summary of the opinion referred to in paragraph 6 and 7 accessible to the public. It shall not disclose any personal data or information of commercially confidential nature. |
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11. The Commission shall set up the technical infrastructure for the data-exchange by electronic means between the MDCG, the special notified bodies and the ACMD, and between the ACMD and itself for the purposes of this Article. |
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12. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the documentation provided in accordance with this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). |
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13. The company concerned shall not be charged for the additional cost due to this assessment. |
Amendment 369
Proposal for a regulation
Article 44 b (new)
Text proposed by the Commission |
Amendment |
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Article 44b |
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Five years after the entry into force of this Regulation, the Commission shall publish a report on the experience acquired as a result of the operation of the procedure referred to in Article 44a. The report shall assess in particular how many products were subject to an additional assessment, what factors triggered the assessment and what was the final decision on the products. It shall also analyse the effects of the full impact of the new rules on special notified bodies vis-a-vis the additional assessments. |
Amendment 167
Proposal for a regulation
Article 45 — paragraph 1
Text proposed by the Commission |
Amendment |
1. The certificates issued by the notified bodies in accordance with Annexes VIII, IX and X shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates is set out in Annex XII. |
1. Before issuing a certificate, the notified conformity assessment body shall take into account any findings set out in the clinical investigation report referred to in Article 59(4). The certificates issued by the notified bodies in accordance with Annexes VIII, IX and X shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates is set out in Annex XII. |
Amendment 168
Proposal for a regulation
Article 45 — paragraph 3
Text proposed by the Commission |
Amendment |
3. Where a notified body finds that requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision. |
3. Where a notified body finds that requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision and shall notify them to the competent authorities of the Member States in which the medical device is manufactured and placed on the market, the Commission and the MDCG. |
Amendment 169
Proposal for a regulation
Article 46 — paragraph 2 a (new)
Text proposed by the Commission |
Amendment |
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2a. It shall notify the competent authorities of the Member States affected by the manufacture and placing on the market of the relevant medical device, the Commission and the MDCG. |
Amendment 170
Proposal for a regulation
Article 47 — paragraph 1
Text proposed by the Commission |
Amendment |
1. By way of derogation from Article 42, any competent authority may authorise, on duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in Article 42 have not been carried out and use of which is in the interest of public health or patient safety. |
1. By way of derogation from Article 42, any competent authority may authorise, on duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in Article 42 have not been carried out and use of which is in the interest of public health or patient safety , provided that the MDCG has authorised it . This derogation shall be possible only if the manufacturer submits the requisite clinical data to the competent authority within the prescribed period. |
Amendment 171
Proposal for a regulation
Article 47 — paragraph 2
Text proposed by the Commission |
Amendment |
2. The Member State shall inform the Commission and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient. |
2. The Member State shall inform the Commission , the notified body responsible for assessing the relevant medical device, the MDCG and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient. |
Amendment 262
Proposal for a regulation
Chapter VI — title
Text proposed by the Commission |
Amendment |
Clinical evaluation and clinical investigations |
Amendment 172
Proposal for a regulation
Article 49 — paragraph 3
Text proposed by the Commission |
Amendment |
3. Where demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performances intended and the claims of the manufacturer. The adequacy of demonstration of conformity with the general safety and performance requirements based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, has to be duly substantiated in the technical documentation referred to in Annex II. |
3. Except for class III devices, where demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performances intended and the claims of the manufacturer. The adequacy of demonstration of conformity with the general safety and performance requirements based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, has to be duly substantiated in the technical documentation referred to in Annex II. |
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Exemption from demonstration of conformity with general safety and performance requirements based on clinical data under the first subparagraph shall be subject to prior approval by the competent authority. |
Amendment 173
Proposal for a regulation
Article 49 — paragraph 5 — subparagraph 1 a (new)
Text proposed by the Commission |
Amendment |
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For devices classified as class III and implantable devices, the summary of safety and clinical performance referred to in Article 26(1) shall be updated at least annually with clinical evaluation reports. |
Amendment 174
Proposal for a regulation
Article 50 — paragraph 1 — point a
Text proposed by the Commission |
Amendment |
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Amendment 175
Proposal for a regulation
Article 50 — paragraph 1 — point b
Text proposed by the Commission |
Amendment |
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Amendment 177
Proposal for a regulation
Article 51 — paragraph 2
Text proposed by the Commission |
Amendment |
2. The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the investigation is to be conducted accompanied by the documentation referred to in Chapter II of Annex XIV. Within six days after receipt of the application, the Member State concerned shall notify the sponsor whether the clinical investigation falls within the scope of this Regulation and whether the application is complete. |
2. The sponsor of a clinical investigation shall submit an application to the Member State(s) in which the investigation is to be conducted accompanied by the documentation referred to in Chapter II of Annex XIV. Within 14 days after receipt of the application, the Member State concerned shall notify the sponsor whether the clinical performance study falls within the scope of this Regulation and whether the application is complete. |
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In case of more than one Member State concerned, where a Member State disagrees with the coordinating Member State on whether the clinical investigation should be approved, on grounds other than intrinsically national, local or ethical concerns, the Member States concerned shall make an attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision after having consulted the Member States concerned, and if appropriate, having taken advice from the MDCG. In case where the concerned Member States object the clinical investigation for intrinsically national, local or ethical concerns the clinical investigation should not take place in the Member States concerned. |
Where the Member State has not notified the sponsor within the time period referred to in the first subparagraph, the clinical investigation shall be considered as falling within the scope of this Regulation and the application shall be considered complete. |
Where the Member State has not notified the sponsor within the time period referred to in the first subparagraph, the clinical investigation shall be considered as falling within the scope of this Regulation and the application shall be considered complete. |
Amendment 178
Proposal for a regulation
Article 51 — paragraph 3 — subparagraph 3
Text proposed by the Commission |
Amendment |
Where the Member State has not notified the sponsor according to paragraph 2 within three days following receipt of the comments or of the completed application, the clinical investigation shall be considered as falling within the scope of this Regulation and the application shall be considered complete. |
Where the Member State has not notified the sponsor according to paragraph 2 within six days following receipt of the comments or of the completed application, the clinical investigation shall be considered as falling within the scope of this Regulation and the application shall be considered complete. |
Amendment 179
Proposal for a regulation
Article 51 — paragraph 5 — point c
Text proposed by the Commission |
Amendment |
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Amendment 180
Proposal for a regulation
Article 51 — paragraph 6
Text proposed by the Commission |
Amendment |
6. Member States shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor, the institution of the investigation site(s) and the investigators involved, as well as free of any other undue influence. |
6. Member States shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor, the institution of the investigation site(s) and the investigators involved, as well as free of any other undue influence. |
Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patient shall be taken into account. |
Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of patients shall be taken into account. |
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The list of the reviewers should be made available to the sponsor |
Amendment 181
Proposal for a regulation
Article 51 — paragraphs 6 a to 6 e (new)
Text proposed by the Commission |
Amendment |
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6a. Every step in the clinical investigation, from first consideration of the need and justification for the study to the publication of the results, shall be carried out in accordance with recognised ethical principles, such as those laid down in the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects adopted by the 18th World Medical Assembly in Helsinki in 1964 and last amended by the 59th World Medical Association General Assembly in Seoul in 2008. |
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6b. Authorisation by the concerned Member State for conducting a clinical investigation under this Article shall be granted only after examination and approval by an independent ethics committee in accordance with the World Medical Association's Declaration of Helsinki. |
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6c. The examination of the Ethics Committee shall cover in particular the medical justification for the clinical investigation, the consent of the test subjects participating in the clinical investigation following the provision of full information about the clinical investigation and the suitability of the investigators and investigation facilities. |
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The ethics committee shall act in accordance with the respective laws and regulations of the country or countries in which the investigation is to be conducted and must abide by all relevant international norms and standards. It shall also work with such efficiency as to enable the Member State concerned to comply with the procedural deadlines set out in this Chapter. |
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The ethics committee shall be made up of an appropriate number of members, who together are in possession of the relevant qualifications and experience in order to be able to assess the scientific, medical and ethical aspects of the clinical investigation under scrutiny. |
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The members of the Ethics Committee assessing the application for a clinical investigation shall be independent from the sponsor, the institution of the investigation site, and the investigators involved, as well as free of any other undue influence. Names, qualifications, and declaration of interest of the assessors of the application shall be made publicly available. |
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6d. Member States shall take the necessary measures to establish Ethics Committees in the field of clinical investigations where such committees do not exist, and to facilitate their work. |
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6e. The Commission shall facilitate cooperation of ethics committees and the sharing of best practices on ethical issues including the procedures and principles of ethical assessment. |
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The Commission shall develop guidelines on patient involvement in ethics committees, drawing upon existing good practices. |
Amendment 182
Proposal for a regulation
Article 52 — paragraph 1 — point g a (new)
Text proposed by the Commission |
Amendment |
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Amendment 183
Proposal for a regulation
Article 52 — paragraph 2 a (new)
Text proposed by the Commission |
Amendment |
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2a. Upon completion of the clinical investigation, the sponsor shall enter in the electronic system referred to in Article 53a summary of its results drawn up in a way that is easy for a lay person to understand. |
Amendment 184
Proposal for a regulation
Article 52 — paragraph 3 — point b
Text proposed by the Commission |
Amendment |
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Amendment 185
Proposal for a regulation
Article 53 — paragraphs 1, 2 and 2a (new)
Text proposed by the Commission |
Amendment |
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1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to create the single identification numbers for on clinical investigations referred to in Article 51(1) and to collate and process the following information: |
1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to create the single identification numbers for on clinical investigations referred to in Article 51(1) and to collate and process the following information: |
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2. When setting up the electronic system referred in paragraph 1, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article […] of Regulation (EU) No [Ref. of future Regulation on clinical trials]. With the exception of the information referred to in Article 52, the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission. |
2. When setting up the electronic system referred in paragraph 1, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article […] of Regulation (EU) No [Ref. of future Regulation on clinical trials]. With the exception of the information referred to in Article 52 and in points (d) and (da) of Article 53 , the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission. The Commission shall also ensure that healthcare professionals have access to the electronic system . |
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The information referred to in points (d) and (da) of Article 53 shall be accessible to the public in accordance with Article 52(3) and (4). |
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2a. Upon a reasoned request, all information on a specific medical device available in the electronic system shall be made accessible to the party requesting it, save where the confidentiality of all or parts of the information is justified in accordance with Article 52(3). |
Amendment 186
Proposal for a regulation
Article 55 — paragraph 2 a (new)
Text proposed by the Commission |
Amendment |
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2a. Assessment by the Member State of the request by the sponsor for a substantial modification to a clinical investigation shall be in accordance with Article 51(6). |
Amendment 187
Proposal for a regulation
Article 56 — paragraph 1
Text proposed by the Commission |
Amendment |
1. Where a Member State has refused, suspended or terminated a clinical investigation, or has called for a substantial modification or temporary halt of a clinical investigation, or has been notified by the sponsor of the early termination of a clinical investigation on safety grounds, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 53. |
1. Where a Member State has refused, suspended or terminated a clinical investigation, or has called for a substantial modification or temporary halt of a clinical investigation, or has been notified by the sponsor of the early termination of a clinical investigation on safety or efficacy grounds, that Member State shall communicate such facts and its decision and the grounds for that decision to all Member States and the Commission by means of the electronic system referred to in Article 53. |
Amendment 188
Proposal for a regulation
Article 57 — paragraph 1
Text proposed by the Commission |
Amendment |
1. If the sponsor has temporarily halted a clinical investigation on safety grounds, he shall inform the Member States concerned within 15 days of the temporary halt. |
1. If the sponsor has temporarily halted a clinical investigation on safety or efficacy grounds, he shall inform the Member States concerned within 15 days of the temporary halt. |
Amendment 189
Proposal for a regulation
Article 57 — paragraph 2
Text proposed by the Commission |
Amendment |
2. The sponsor shall notify each Member State concerned of the end of a clinical investigation in relation to that Member State, providing a justification in the event of early termination. That notification shall be made within 15 days from the end of the clinical investigation in relation to that Member State. |
2. The sponsor shall notify each Member State concerned of the end of a clinical investigation in relation to that Member State, providing a justification in the event of early termination , so that all Member States can inform sponsors conducting similar clinical investigations at the same time within the Union of the results of that clinical investigation. That notification shall be made within 15 days from the end of the clinical investigation in relation to that Member State. |
If the investigation is conducted in more than one Member State the sponsor shall notify all Member States concerned of the overall end of the clinical investigation. That notification shall be made within 15 days from the overall end of the clinical investigation. |
If the investigation is conducted in more than one Member State the sponsor shall notify all Member States concerned of the early termination in one Member State and of the overall end of the clinical investigation. Information on the reasons for the early termination of the clinical investigation shall also be provided to all Member States, so that all Member States can inform sponsors conducting similar clinical investigations at the same time within the Union of the results of that clinical investigation. That notification shall be made within 15 days from the end of the clinical investigation in one or more Member States . |
Amendment 190
Proposal for a regulation
Article 57 — paragraph 3
Text proposed by the Commission |
Amendment |
3. Within one year from the end of the clinical investigation, the sponsor shall submit to the Member States concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in Section 2.7 of Chapter I of Annex XIV. Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year, it shall be submitted as soon as it is available. In this case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XIV shall specify when the results of the clinical investigation are going to be submitted, together with an explanation. |
3. Irrespective of the outcome of the clinical investigation, within one year from the end of the clinical performance study or from its early termination , the sponsor shall submit to the Member States concerned the results of the clinical investigation in form of a clinical investigation report referred to in Section 2.7 of Chapter I of Annex XIV . It shall be accompanied by a summary presented in terms that are easily understandable to a layperson. Both the report and the summary shall be submitted by the sponsor by means of the electronic system referred to in Article 53. Where, for justified scientific reasons, it is not possible to submit the clinical investigation report within one year, it shall be submitted as soon as it is available. In this case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XIV shall specify when the results of the clinical investigation are going to be submitted, together with a justification. |
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3a. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to define the content and structure of the layperson's summary. |
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The Commission shall be empowered to adopt delegated acts in accordance with Article 89 in order to establish rules for the communication of the clinical investigation report. |
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For cases where the sponsor decides to share raw data on a voluntary basis, the Commission shall produce guidelines for the formatting and sharing of the data. |
Amendment 191
Proposal for a regulation
Article 58 — paragraph 1
Text proposed by the Commission |
Amendment |
1. By means of the electronic system referred to in Article 53, the sponsor of a clinical investigation to be conducted in more than one Member State may submit, for the purpose of Article 51, a single application that, upon receipt, is transmitted electronically to the Member States concerned. |
1. By means of the electronic system referred to in Article 53, the sponsor of a clinical investigation may submit, for the purpose of Article 51, the application that, upon receipt, is transmitted electronically to the Member States concerned. |
Amendment 192
Proposal for a regulation
Article 58 — paragraph 2
Text proposed by the Commission |
Amendment |
2. In the single application, the sponsor shall propose one of the Member States concerned as coordinating Member State. If that Member State does not wish to be the coordinating Member State, it shall agree, within six days of submission of the single application, with another Member State concerned that the latter shall be the coordinating Member State. If no other Member State accepts to be the coordinating Member State, the Member State proposed by the sponsor shall be the coordinating Member State. If another Member State than the one proposed by the sponsor becomes coordinating Member State , the deadline referred to in Article 51(2) shall start on the day following the acceptance . |
2. Concerned Member States shall agree, within six days of submission of the single application, which Member State shall be the coordinating Member State. Member States and the Commission shall agree, in the framework of the attributions of the MDCG, on clear rules for designating the coordinating Member State. |
Amendment 193
Proposal for a regulation
Article 58 — paragraph 3 — subparagraph 2 — point b
Text proposed by the Commission |
Amendment |
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Amendment 194
Proposal for a regulation
Article 58 — paragraph 5
Text proposed by the Commission |
Amendment |
5. For the purpose of Article 57(3), the sponsor shall submit the clinical performance study report to the Member States concerned by means of the electronic system referred to in Article 53. |
deleted |
Amendment 195
Proposal for a regulation
Article 59 — paragraph 1 — subparagraph 1 a (new)
Text proposed by the Commission |
Amendment |
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Information regarding incidents that are caused by user errors shall also be collected, as they are a major source of incidents with medical devices. This information shall contribute to improve the safety and knowledge of the device. |
Amendment 196
Proposal for a regulation
Article 59 — paragraph 1 — subparagraph 1 b (new)
Text proposed by the Commission |
Amendment |
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Member States shall put in place non-electronic formats of reporting to ensure that patients who do not have online access are able to report. |
Amendment 197
Proposal for a regulation
Article 59 — paragraph 4 — subparagraph 1
Text proposed by the Commission |
Amendment |
In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 58, the sponsor shall report any event as referred to in paragraph 2 by means of the electronic system referred to in Article 53. Upon receipt, this report shall be transmitted electronically to all Member States concerned. |
In the case of a clinical investigation for which the sponsor has used the single application referred to in Article 58, the sponsor shall report any event as referred to in paragraphs 1 and 2 by means of the electronic system referred to in Article 53. Upon receipt, this report shall be transmitted electronically to all Member States concerned. |
Amendment 263
Proposal for a regulation
Chapter VII — title
Text proposed by the Commission |
Amendment |
Vigilance and market surveillance |
Amendment 198
Proposal for a regulation
Article 61
Text proposed by the Commission |
Amendment |
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1. Manufacturers of devices other than custom-made or investigational devices, shall report through the electronic system referred to in Article 62 the following: |
1. Manufacturers of devices other than custom-made or investigational devices, shall report through the electronic system referred to in Article 62 the following: |
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Manufacturers shall make the report referred to in the first subparagraph without delay, and no later than 15 days after they have become aware of the event and the causal relationship with their device or that such causal relationship is reasonably possible. The time period for reporting shall take account of the severity of the incident. Where necessary to ensure timely reporting, the manufacturer may submit an initial incomplete report followed up by a complete report. |
Manufacturers shall make the report referred to in the first subparagraph without delay, and no later than 15 days after they have become aware of the event and the causal relationship with their device or that such causal relationship is reasonably possible. The time period for reporting shall take account of the severity of the incident. Where necessary to ensure timely reporting, the manufacturer may submit an initial incomplete report followed up by a complete report. |
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2. For similar serious incidents occurring with the same device or device type and for which the root cause has been identified or the field safety corrective action implemented, manufacturers may provide periodic summary reports instead of individual incident reports, on condition that the competent authorities referred to in points (a), (b) and (c) of Article 62(5) have agreed with the manufacturer on the format, content and frequency of the periodic summary reporting. |
2. For similar incidents occurring with the same device or device type and for which the root cause has been identified or the field safety corrective action implemented, manufacturers may provide periodic summary reports instead of individual incident reports, on condition that the competent authorities referred to in points (a), (b) and (c) of Article 62(5) have agreed with the manufacturer on the format, content and frequency of the periodic summary reporting. |
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3. The Member States shall take all appropriate measures to encourage healthcare professionals, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. |
3. The Member States shall take all appropriate measures, including targeted information campaigns, to encourage and enable healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected incidents referred to in point (a) of paragraph 1. They shall inform the Commission of those measures. |
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They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident . The manufacturer shall ensure the appropriate follow-up. |
The competent authorities of the Member States shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall inform the manufacturer of the device concerned without delay . The manufacturer shall ensure the appropriate follow-up. |
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The competent authority of a Member State shall notify the reports referred to in the first subparagraph to the electronic system referred to in Article 62 without delay, unless the same incident has already been reported by the manufacturer. |
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The Member States shall coordinate between them the development of standard web-based structured forms for reporting of serious incidents by healthcare professionals, users and patients. |
The Commission, in cooperation with the Member States and in consultation with the relevant stakeholders, shall develop standard forms for electronic and non-electronic reporting of incidents by healthcare professionals, users and patients. |
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4. Manufacturers of custom-made devices shall report any serious incidents and field safety corrective actions referred to in paragraph 1 to the competent authority of the Member State in which the device in question has been made available. |
4. Manufacturers of custom-made devices shall immediately report any incidents and field safety corrective actions referred to in paragraph 1 to the competent authority of the Member State in which the device in question has been made available. |
Amendment 199
Proposal for a regulation
Article 62
Text proposed by the Commission |
Amendment |
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1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information: |
1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collate and process the following information: |
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2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission and to the notified bodies. |
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission, to the notified bodies, to healthcare professionals and also to manufacturers where the information pertains to their own product . |
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3. The Commission shall ensure that healthcare professionals and the public have appropriate levels of access to the electronic system. |
3. The Commission shall ensure that the public has an appropriate level of access to the electronic system. In case where information is requested on a specific medical device, that information shall be made available without delay and within 15 days at the latest. |
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4. On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the database at the appropriate level. Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union. |
4. On the basis of arrangements between the Commission and competent authorities of third countries or international organisations, the Commission may grant those competent authorities or international organisations access to the database at the appropriate level. Those arrangements shall be based on reciprocity and make provision for confidentiality and data protection equivalent to those applicable in the Union. |
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5. The reports on serious incidents and field safety corrective actions referred to in points (a) and (b) of Article 61(1), the periodic summary reports referred to in Article 61(2), the reports on serious incidents referred to in the second subparagraph of Article 63(1) and the trend reports referred to in Article 64 shall be automatically transmitted upon receipt via the electronic system to the competent authorities of the following Member States: |
5. The reports on serious incidents and field safety corrective actions referred to in points (a) and (b) of Article 61(1), the periodic summary reports referred to in Article 61(2), the reports on incidents referred to in the second subparagraph of Article 63(1) and the trend reports referred to in Article 64 shall be automatically transmitted upon receipt via the electronic system to the competent authorities of the following Member States: |
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5a. The reports and information referred to in Article 62(5), shall also be automatically transmitted for the device in question via the electronic system to the notified body that issued the certificate in accordance with Article 45. |
Amendment 200
Proposal for a regulation
Article 63 — paragraph 1 — subparagraph 1
Text proposed by the Commission |
Amendment |
Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 61 is, at national level, evaluated centrally by their competent authority, if possible together with the manufacturer. |
Member States shall take the necessary steps to ensure that any information regarding an incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 61 is, at national level, evaluated centrally by their competent authority, if possible together with the manufacturer. The competent authority shall take into account the views of all relevant stakeholders, including patient and healthcare professionals' organisations. |
Amendment 201
Proposal for a regulation
Article 63 — paragraph 1 — subparagraph 2
Text proposed by the Commission |
Amendment |
If in the case of reports received in accordance with Article 61(3) the competent authority ascertains that the reports relate to a serious incident it shall notify without delay those reports to the electronic system referred to in Article 62, unless the same incident has already been reported by the manufacturer. |
deleted |
Amendment 202
Proposal for a regulation
Article 63 — paragraph 2
Text proposed by the Commission |
Amendment |
2. The national competent authorities shall carry out a risk assessment with regard to reported serious incidents or field safety corrective actions, taking into account criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of harm and severity of harm, clinical benefit of the device, intended and potential users, and population affected. They shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action. They shall monitor the manufacturer's investigation of the incident. |
2. The national competent authorities shall carry out a risk assessment with regard to reported incidents or field safety corrective actions, taking into account criteria such as causality, detectability and probability of recurrence of the problem, frequency of use of the device, probability of occurrence of harm and severity of harm, clinical benefit of the device, intended and potential users, and population affected. They shall also evaluate the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for and kind of any other corrective action. They shall monitor the manufacturer's investigation of the incident , as well as they shall take into account patients' opinions . |
Amendment 203
Proposal for a regulation
Article 63 — paragraph 3 — subparagraph 1
Text proposed by the Commission |
Amendment |
In the case of devices referred to in the first subparagraph of Article 1(4) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for medicinal products, or the European Medicines Agency (EMA), that was consulted by the notified body in accordance with the second subparagraph of Article 42(2). |
In the case of devices referred to in the first subparagraph of Article 1(4) and where the incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the evaluating competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for medicinal products, or the EMA, that was consulted by the notified body in accordance with the second subparagraph of Article 42(2). |
Amendment 204
Proposal for a regulation
Article 63 — paragraph 3 — subparagraph 2
Text proposed by the Commission |
Amendment |
In the case of devices covered by this Regulation in accordance with point (e) of Article 1(2) and where the serious incident or field safety corrective action may be related to the tissues or cells of human origin utilised for the manufacture of the device, the competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for human tissues and cells that was consulted by the notified body in accordance with the third subparagraph of Article 42(2). |
In the case of devices covered by this Regulation in accordance with point (e) of Article 1(2) and where the incident or field safety corrective action may be related to the tissues or cells of human origin utilised for the manufacture of the device, the competent authority or the coordinating competent authority referred to in paragraph 6 shall inform the relevant competent authority for human tissues and cells that was consulted by the notified body in accordance with the third subparagraph of Article 42(2). |
Amendment 205
Proposal for a regulation
Article 63 — paragraph 4
Text proposed by the Commission |
Amendment |
4. After carrying out the assessment, the evaluating competent authority shall, through the electronic system referred to in Article 62, inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or imposed on him to minimise the risk of recurrence of a serious incident , including information on the underlying events and the outcome of its assessment. |
4. After carrying out the assessment, the evaluating competent authority shall, through the electronic system referred to in Article 62, inform without delay the other competent authorities of the corrective action taken or envisaged by the manufacturer or imposed on him to minimise the risk of recurrence, including information on the underlying events and the outcome of its assessment. |
Amendment 206
Proposal for a regulation
Article 63 — paragraph 6 — subparagraph 1 — point a
Text proposed by the Commission |
Amendment |
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Amendment 207
Proposal for a regulation
Article 63 — paragraph 7 — subparagraph 1 — point a
Text proposed by the Commission |
Amendment |
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Amendment 208
Proposal for a regulation
Article 63 — paragraph 7 — subparagraph 1 — point b
Text proposed by the Commission |
Amendment |
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Amendment 209
Proposal for a regulation
Article 63 a (new)
Text proposed by the Commission |
Amendment |
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Article 63 a |
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Periodic safety update reports |
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1. Manufacturers of medical devices classified as class III shall report to the electronic system referred to in Article 62: |
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2. Manufacturers shall submit periodic safety update reports to the competent authorities immediately upon request or at least once a year during the first 2 years following initial placing on the market of that medical device. |
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3. The MDCG shall assess the periodic safety update reports to determine whether there are new risks or whether risks have changed, or whether there are changes to the risk-benefit ratio of the medical device. |
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4. Following the assessment of the periodic safety update reports, the MDCG shall consider whether any action regarding the medical device concerned is necessary. The MDCG shall inform the notified body in case of unfavourable scientific assessment. In this case, the notified body shall maintain, vary, suspend or revoke the authorisation as appropriate. |
Amendment 210
Proposal for a regulation
Article 64 — paragraph 1
Text proposed by the Commission |
Amendment |
Manufacturers of devices classified in class IIb and III shall report to the electronic system referred to in Article 62 any statistically significant increase in the frequency or severity of incidents that are not serious incidents or of expected undesirable side-effects that have a significant impact on the risk-benefit analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons when weighted against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents or expected undesirable side-effects in respect of the device, or category or group of devices, in question during a specific time period as established in the manufacturer's conformity assessment. Article 63 shall apply. |
Manufacturers of devices classified in class IIb and III shall report to the electronic system referred to in Article 62 any statistically significant increase in the frequency or severity of all incidents or of expected undesirable side-effects that have a significant impact on the risk-benefit analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons when weighted against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents or expected undesirable side-effects in respect of the device, or category or group of devices, in question during a specific time period as established in the manufacturer's conformity assessment. Article 63 shall apply. |
Amendment 211
Proposal for a regulation
Article 64 a (new)
Text proposed by the Commission |
Amendment |
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Article 64a |
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Medical devices which fall under legal acts of the European Union concerning the quality and safety of blood |
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1. This Regulation is without prejudice to existing and implemented provisions at European level relating to the collection, testing, processing, storage and distribution of blood and blood components. |
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2. This Regulation is without prejudice to national laws and Union legislation in the field of traceability and vigilance in the field of blood and blood components which have a higher standard than this Regulation. They should be retained in the interests of patients. |
Amendment 212
Proposal for a regulation
Article 66 — paragraph 1 — point a