02014L0053 — EN — 01.10.2023 — 003.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
DIRECTIVE 2014/53/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153 22.5.2014, p. 62) |
Amended by:
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No |
page |
date |
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REGULATION (EU) 2018/1139 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2018 |
L 212 |
1 |
22.8.2018 |
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DIRECTIVE (EU) 2022/2380 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 November 2022 |
L 315 |
30 |
7.12.2022 |
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COMMISSION DELEGATED REGULATION (EU) 2023/1717 of 27 June 2023 |
L 223 |
1 |
11.9.2023 |
DIRECTIVE 2014/53/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 April 2014
on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC
(Text with EEA relevance)
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter and scope
Article 2
Definitions
For the purposes of this Directive, the following definitions apply:
‘radio equipment’ means an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination;
‘radio communication’ means communication by means of radio waves;
‘radiodetermination’ means the determination of the position, velocity and/or other characteristics of an object, or the obtaining of information relating to those parameters, by means of the propagation properties of radio waves;
‘radio waves’ means electromagnetic waves of frequencies lower than 3 000 GHz, propagated in space without artificial guide;
‘radio interface’ means the specification of the regulated use of radio spectrum;
‘radio equipment class’ means a class identifying particular categories of radio equipment which, under this Directive, are considered similar and those radio interfaces for which the radio equipment is designed;
‘harmful interference’ means harmful interference as defined in point (r) of Article 2 of Directive 2002/21/EC of the European Parliament and of the Council ( 1 );
‘electromagnetic disturbance’ means electromagnetic disturbance as defined in point 5 of Article 3(1) of Directive 2014/30/EU;
‘making available on the market’ means any supply of radio equipment for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
‘placing on the market’ means the first making available of radio equipment on the Union market;
‘putting into service’ means the first use of radio equipment in the Union by its end-user;
‘manufacturer’ means any natural or legal person who manufactures radio equipment or has radio equipment designed or manufactured, and markets that equipment under his name or trade mark;
‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
‘importer’ means any natural or legal person established within the Union who places radio equipment from a third country on the Union market;
‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes radio equipment available on the market;
‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;
‘technical specification’ means a document that prescribes technical requirements to be fulfilled by radio equipment;
‘harmonised standard’ means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;
‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
‘conformity assessment’ means the process demonstrating whether the essential requirements of this Directive relating to radio equipment have been fulfilled;
‘conformity assessment body’ means a body that performs conformity assessment activities;
‘recall’ means any measure aimed at achieving the return of radio equipment that has already been made available to the end-user;
‘withdrawal’ means any measure aimed at preventing radio equipment in the supply chain from being made available on the market;
‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;
‘CE marking’ means a marking by which the manufacturer indicates that the radio equipment is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.
Article 3
Essential requirements
Radio equipment shall be constructed so as to ensure:
the protection of health and safety of persons and of domestic animals and the protection of property, including the objectives with respect to safety requirements set out in Directive 2014/35/EU, but with no voltage limit applying;
an adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU.
Radio equipment within certain categories or classes shall be so constructed that it complies with the following essential requirements:
radio equipment interworks with accessories other than the charging devices for the categories or classes of radio equipment, specified in Part I of Annex Ia, which are specifically referred to in paragraph 4 of this Article;
radio equipment interworks via networks with other radio equipment;
radio equipment can be connected to interfaces of the appropriate type throughout the Union;
radio equipment does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service;
radio equipment incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected;
radio equipment supports certain features ensuring protection from fraud;
radio equipment supports certain features ensuring access to emergency services;
radio equipment supports certain features in order to facilitate its use by users with a disability;
radio equipment supports certain features in order to ensure that software can only be loaded into the radio equipment where the compliance of the combination of the radio equipment and software has been demonstrated.
The Commission shall be empowered to adopt delegated acts in accordance with Article 44 specifying which categories or classes of radio equipment are concerned by each of the requirements set out in points (a) to (i) of the first subparagraph of this paragraph.
With respect to radio equipment capable of being recharged by means of wired charging, the Commission is empowered to adopt delegated acts in accordance with Article 44 to amend Part I of Annex Ia in the light of scientific and technological progress or market developments in order to ensure a minimum common interoperability between radio equipment and its charging devices, as well as to improve consumer convenience, to reduce environmental waste and to avoid market fragmentation, by:
modifying, adding or removing categories or classes of radio equipment;
modifying, adding or removing technical specifications, including references and descriptions, in relation to the charging receptacle(s) and charging communication protocol(s), for each category or class of radio equipment concerned.
The Commission shall continuously assess market developments, market fragmentation and technological progress with a view to identifying categories or classes of radio equipment capable of being recharged by means of wired charging for which the inclusion in Part I of Annex Ia would lead to significant consumer convenience and reduction of environmental waste.
The Commission shall submit a report on the assessment referred to in the third subparagraph to the European Parliament and to the Council, for the first time by 28 December 2025 and every 5 years thereafter, and shall adopt delegated acts pursuant to the second subparagraph, point (a), accordingly.
With respect to radio equipment capable of being recharged by means other than wired charging, the Commission is empowered to adopt delegated acts in accordance with Article 44 in order to amend Part I of Annex Ia in the light of scientific and technological progress or market developments in order to ensure a minimum common interoperability between radio equipment and its charging devices, as well as to improve consumer convenience, to reduce environmental waste and to avoid market fragmentation, by:
introducing, modifying, adding or removing categories or classes of radio equipment;
introducing, modifying, adding or removing technical specifications, including references and descriptions, in relation to charging interface(s) and charging communication protocol(s), for each category or class of radio equipment concerned.
The Commission shall, in accordance with Article 10(1) of Regulation (EU) No 1025/2012, and by 28 December 2024, request one or more European standardisation organisations to draft harmonised standards laying down technical specifications for the charging interface(s) and charging communication protocol(s) for radio equipment capable of being recharged by means other than wired charging. In accordance with the procedure laid down in Article 10(2) of Regulation (EU) No 1025/2012, the Commission shall consult the committee set up under Article 45(1) of this Directive. The requirements as to the content of the requested harmonised standards shall be based on an assessment carried out by the Commission of the current state of wireless charging technologies for radio equipment, covering in particular market developments, market penetration, market fragmentation, technological performance, interoperability, energy efficiency and charging performance.
When preparing the delegated acts referred to in this Article with respect to radio equipment capable of being recharged by means of wired charging, as well as with respect to radio equipment capable of being recharged by means other than wired charging, the Commission shall take into account the degree of market acceptance of the technical specifications under consideration, the resulting consumer convenience and the extent of the reduction of environmental waste and market fragmentation that can be expected from such technical specifications. Technical specifications that are based on relevant available European or international standards shall be deemed to meet the objectives set out in the previous sentence. However, where such European or international standards do not exist, or where the Commission determines, based on its technical assessment, that they do not meet those objectives in an optimal manner, the Commission may set out other technical specifications which better meet those objectives.
Article 3a
Possibility for consumers and other end-users to acquire certain categories or classes of radio equipment without a charging device
Where an economic operator offers to consumers and other end-users the possibility to acquire the radio equipment referred to in Article 3(4) together with a charging device, the economic operator shall also offer the consumers and other end-users the possibility of acquiring that radio equipment without any charging device.
Economic operators shall ensure that the information on whether or not a charging device is included with the radio equipment referred to in Article 3(4) is displayed in a graphic form using a user-friendly and easily accessible pictogram as set out in Part III of Annex Ia when such radio equipment is made available to consumers and other end-users. The pictogram shall be printed on the packaging or affixed to the packaging as a sticker. When the radio equipment is made available to consumers and other end-users, the pictogram shall be displayed in a visible and legible manner and, in the case of distance selling, close to the price indication.
The Commission is empowered to adopt delegated acts in accordance with Article 44 in order to amend Part III of Annex Ia as a consequence of amendments to Parts I and II of that Annex, or as a consequence of future amendments to labelling requirements, or in the light of technological progress, by introducing, modifying, adding or removing any graphic or textual elements.
Article 4
Provision of information on the compliance of combinations of radio equipment and software
Article 5
Registration of radio equipment types within some categories
Article 6
Making available on the market
Member States shall take appropriate measures to ensure that radio equipment is made available on the market only if it complies with this Directive.
Article 7
Putting into service and use
Member States shall allow the putting into service and use of radio equipment if it complies with this Directive when it is properly installed, maintained and used for its intended purpose. Without prejudice to their obligations under Decision No 676/2002/EC and to the conditions attached to authorisations for the use of frequencies in conformity with Union law, in particular under Article 9(3) and (4) of Directive 2002/21/EC, Member States may only introduce additional requirements for the putting into service and/or use of radio equipment for reasons related to the effective and efficient use of the radio spectrum, to the avoidance of harmful interference, to the avoidance of electromagnetic disturbances or to public health.
Article 8
Notification of radio interface specifications and assignment of radio equipment classes
Member States shall notify, in accordance with the procedure set out in Directive 98/34/EC, the radio interfaces which they intend to regulate except:
the radio interfaces which fully and without any deviation comply with the Commission decisions on the harmonised use of radio spectrum adopted pursuant to Decision No 676/2002/EC; and
the radio interfaces which, in accordance with implementing acts adopted pursuant to paragraph 2 of this Article, correspond to radio equipment which can be put into service and used without restrictions within the Union.
Article 9
Free movement of radio equipment
CHAPTER II
OBLIGATIONS OF ECONOMIC OPERATORS
Article 10
Obligations of manufacturers
Where compliance of radio equipment with the applicable requirements has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.
When deemed appropriate with regard to the risks presented by radio equipment, manufacturers shall, to protect the health and safety of end-users, carry out sample testing of radio equipment made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming radio equipment and radio equipment recalls, and shall keep distributors informed of any such monitoring.
The following information shall also be included in the instructions in the case of radio equipment intentionally emitting radio waves:
frequency band(s) in which the radio equipment operates;
maximum radio-frequency power transmitted in the frequency band(s) in which the radio equipment operates.
In the case of radio equipment referred to in Article 3(4), the instructions shall contain information on the specifications relating to the radio equipment’s charging capabilities and the compatible charging devices, as set out in Part II of Annex Ia. In addition to being included in the instructions, when the manufacturers make such radio equipment available to consumers and other end-users, the information shall be also displayed on a label, as set out in Part IV of Annex Ia. The label shall be printed in the instructions and on the packaging or affixed to the packaging as a sticker. In the absence of packaging, the sticker with the label shall be affixed to the radio equipment. When the radio equipment is made available to consumers and other end-users, the label shall be displayed in a visible and legible manner and, in the case of distance selling, close to the price indication. Where the size or nature of the radio equipment does not allow otherwise, the label may be printed as a separate document accompanying the radio equipment.
The instructions and safety information referred to in the first, second and third subparagraphs of this paragraph shall be in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
The Commission is empowered to adopt delegated acts in accordance with Article 44 in order to amend Parts II and IV of Annex Ia, as a consequence of amendments to Part I of that Annex, or as a consequence of future amendments to labelling requirements, or in the light of technological progress, by introducing, modifying, adding or removing any details in relation to the information, graphic or textual elements, as set out in this Article.
Article 11
Authorised representatives
The obligations laid down in Article 10(1) and the obligation to draw up technical documentation laid down in Article 10(3) shall not form part of the authorised representative's mandate.
An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:
keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 10 years after the radio equipment has been placed on the market;
further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of radio equipment;
cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by radio equipment covered by the authorised representative's mandate.
Article 12
Obligations of importers
Where an importer considers or has reason to believe that radio equipment is not in conformity with the essential requirements set out in Article 3, he shall not place the radio equipment on the market until it has been brought into conformity. Furthermore, where the radio equipment presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.
When making the radio equipment referred to in Article 3(4) available to consumers and other end-users, importers shall ensure that:
such radio equipment displays, or is supplied with, a label in accordance with Article 10(8), third subparagraph;
that label is displayed in a visible and legible manner and, in the case of distance selling, close to the price indication.
Article 13
Obligations of distributors
Where a distributor considers or has reason to believe that radio equipment is not in conformity with the essential requirements set out in Article 3, he shall not make the radio equipment available on the market until it has been brought into conformity. Furthermore, where the radio equipment presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.
When making the radio equipment referred to in Article 3(4) available to consumers and other end-users, distributors shall ensure that:
such radio equipment displays, or is supplied with, a label in accordance with Article 10(8), third subparagraph;
that label is displayed in a visible and legible manner and, in the case of distance selling, close to the price indication.
Article 14
Cases in which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be considered a manufacturer for the purposes of this Directive and he shall be subject to the obligations of the manufacturer under Article 10, where he places radio equipment on the market under his name or trade mark or modifies radio equipment already placed on the market in such a way that compliance with this Directive may be affected.
Article 15
Identification of economic operators
Economic operators shall, on request, identify the following to the market surveillance authorities:
any economic operator who has supplied them with radio equipment;
any economic operator to whom they have supplied radio equipment.
Economic operators shall be able to present the information referred to in the first paragraph for 10 years after they have been supplied with the radio equipment and for 10 years after they have supplied the radio equipment.
CHAPTER III
CONFORMITY OF RADIO EQUIPMENT
Article 16
Presumption of conformity of radio equipment
Radio equipment which is in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements set out in Article 3 covered by those standards or parts thereof.
Article 17
Conformity assessment procedures
Manufacturers shall demonstrate compliance of radio equipment with the essential requirements set out in ►M2 Article 3(1) and (4) ◄ using any of the following conformity assessment procedures:
internal production control set out in Annex II;
EU-type examination that is followed by the conformity to type based on internal production control set out in Annex III;
conformity based on full quality assurance set out in Annex IV.
Where, in assessing the compliance of radio equipment with the essential requirements set out in Article 3(2) and (3), the manufacturer has applied harmonised standards the references of which have been published in the Official Journal of the European Union, he shall use any of the following procedures:
internal production control set out in Annex II;
EU-type examination that is followed by the conformity to type based on internal production control set out in Annex III;
conformity based on full quality assurance set out in Annex IV.
Where, in assessing the compliance of radio equipment with the essential requirements set out in Article 3(2) and (3), the manufacturer has not applied or has applied only in part harmonised standards the references of which have been published in the Official Journal of the European Union, or where such harmonised standards do not exist, radio equipment shall be submitted with regard to those essential requirements to either of the following procedures:
EU-type examination that is followed by the conformity to type based on internal production control set out in Annex III;
conformity based on full quality assurance set out in Annex IV.
Article 18
EU declaration of conformity
The simplified EU declaration of conformity referred to in Article 10(9) shall contain the elements set out in Annex VII and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the radio equipment is placed or made available on the market. The full text of the EU declaration of conformity shall be available at the internet address referred to in the simplified EU declaration of conformity, in a language or languages required by the Member State in which the radio equipment is placed or made available on the market.
Article 19
General principles of the CE marking
Article 20
Rules and conditions for affixing the CE marking and the identification number of the notified body
The identification number of the notified body shall have the same height as the CE marking.
The identification number of the notified body shall be affixed by the notified body itself or, under its instructions, by the manufacturer or his authorised representative.
Article 21
Technical documentation
CHAPTER IV
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 22
Notification
Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Directive.
Article 23
Notifying authorities
Article 24
Requirements relating to notifying authorities
Article 25
Information obligation on notifying authorities
Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.
The Commission shall make that information publicly available.
Article 26
Requirements relating to notified bodies
A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of radio equipment which it assesses may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of that radio equipment, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
At all times and for each conformity assessment procedure and each kind or category of radio equipment in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:
personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;
descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;
procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of radio equipment technology in question and the mass or serial nature of the production process.
A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner.
The personnel responsible for carrying out conformity assessment tasks shall have the following:
sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
appropriate knowledge and understanding of the essential requirements set out in Article 3, of the applicable harmonised standards and of the relevant provisions of Union harmonisation legislation and of national legislation;
the ability to draw up EU-type examination certificates or quality system approvals, records and reports demonstrating that assessments have been carried out.
The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.
Article 27
Presumption of conformity of notified bodies
Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article 26 in so far as the applicable harmonised standards cover those requirements.
Article 28
Subsidiaries of and subcontracting by notified bodies
Article 29
Application for notification
Article 30
Notification procedure
Only such a body shall be considered a notified body for the purposes of this Directive.
Article 31
Identification numbers and lists of notified bodies
It shall assign a single such number even where the body is notified under several Union acts.
The Commission shall ensure that the list is kept up to date.
Article 32
Changes to notifications
Article 33
Challenge of the competence of notified bodies
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 45(2).
Article 34
Operational obligations of notified bodies
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the radio equipment with this Directive.
Article 35
Appeal against decisions of notified bodies
Member States shall ensure that an appeal procedure against decisions of the notified bodies is available.
Article 36
Information obligation on notified bodies
Notified bodies shall inform the notifying authority of the following:
any refusal, restriction, suspension or withdrawal of an EU-type examination certificate or a quality system approval in accordance with the requirements of Annexes III and IV;
any circumstances affecting the scope of or conditions for notification;
any request for information which they have received from market surveillance authorities regarding conformity assessment activities;
on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.
Article 37
Exchange of experience
The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.
Article 38
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Directive are put in place and properly operated in the form of a sectoral group of notified bodies.
Member States shall ensure that the bodies notified by them participate in the work of that group, directly or by means of designated representatives.
CHAPTER V
UNION MARKET SURVEILLANCE, CONTROL OF RADIO EQUIPMENT ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
Article 39
Union market surveillance and control of radio equipment entering the Union market
Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to radio equipment.
Article 40
Procedure at national level for dealing with radio equipment presenting a risk or not in compliance with essential requirements
Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the radio equipment does not comply with the requirements laid down in this Directive, they shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the radio equipment into compliance with those requirements, to withdraw the radio equipment from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe.
The market surveillance authorities shall inform the relevant notified body accordingly.
Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant radio equipment, the origin of the radio equipment, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to either of the following:
failure of the radio equipment to meet the relevant essential requirements set out in Article 3; or
shortcomings in the harmonised standards referred to in Article 16 conferring a presumption of conformity.
Article 41
Union safeguard procedure
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
Article 42
Compliant radio equipment which presents a risk
The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 45(3).
On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 45(4).
Article 43
Formal non-compliance
Without prejudice to Article 40, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 20 of this Directive;
the CE marking has not been affixed;
the identification number of the notified body, where the conformity assessment procedure set out in Annex IV is applied, has been affixed in violation of Article 20 or has not been affixed;
the EU declaration of conformity has not been drawn up;
the EU declaration of conformity has not been drawn up correctly;
technical documentation is either not available or not complete;
the pictogram as referred to in Article 3a(2), or the label as referred to in Article 10(8), has not been drawn up correctly;
the label as referred to in Article 10(8) does not accompany the radio equipment concerned;
the pictogram or the label is not affixed or displayed in accordance with Article 3a(2) or Article 10(8), respectively;
the information referred to in Article 10(6) or (7) or Article 12(3) is absent, false or incomplete;
the information referred to in Article 10(8), the EU declaration of conformity referred to in Article 10(9) or the information on usage restrictions referred to in Article 10(10) does not accompany the radio equipment;
requirements on identification of economic operators set out in Article 15 are not fulfilled;
Article 3a(1) or Article 5 is not complied with.
CHAPTER VI
DELEGATED ACTS AND IMPLEMENTING ACTS AND THE COMMITTEE
Article 44
Exercise of the delegation
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making ( 2 ).
Article 45
Committee procedure
The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.
CHAPTER VII
FINAL AND TRANSITIONAL PROVISIONS
Article 46
Penalties
Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of national law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced. Such rules may include criminal penalties for serious infringements.
The penalties provided for shall be effective, proportionate and dissuasive.
Article 47
Review and reporting
The Commission shall review the operation of this Directive and report thereon to the European Parliament and to the Council, by 12 June 2018 and every five years thereafter. The report shall cover progress on drawing up the relevant standards, as well as any problems that have arisen in the course of implementation. The report shall also outline the activities of the Telecommunication Conformity Assessment and Market Surveillance Committee, assess progress in achieving an open competitive market for radio equipment at Union level and examine how the regulatory framework for the making available on the market and putting into service of radio equipment should be developed in order to achieve the following:
ensure that a coherent system is achieved at Union level for all radio equipment;
allow for convergence of the telecommunications, audiovisual and information technology sectors;
enable regulatory measures to be harmonised at international level;
reach a high level of consumer protection;
ensure that portable radio equipment interworks with accessories, in particular with common chargers;
where radio equipment is fitted with an integral screen, allow the display of the required information on the integral screen.
Article 48
Transitional provisions
Member States shall not impede, for the aspects covered by this Directive, the making available on the market or putting into service of radio equipment covered by this Directive which is in conformity with the relevant Union harmonisation legislation applicable before 13 June 2016 and which was placed on the market before 13 June 2017.
Article 49
Transposition
They shall apply those measures from 13 June 2016.
When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.
Article 50
Repeal
Directive 1999/5/EC is repealed with effect from 13 June 2016.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VIII.
Article 51
Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 52
Addressees
This Directive is addressed to the Member States.
ANNEX I
EQUIPMENT NOT COVERED BY THIS DIRECTIVE
1. Radio equipment used by radio amateurs within the meaning of Article 1, definition 56, of the International Telecommunications Union (ITU) Radio Regulations, unless the equipment is made available on the market.
The following shall be regarded as not being made available on the market:
radio kits for assembly and use by radio amateurs;
radio equipment modified by and for the use of radio amateurs;
equipment constructed by individual radio amateurs for experimental and scientific purposes related to amateur radio.
2. Marine equipment falling within the scope of Council Directive 96/98/EC ( 3 ).
3. The following aviation equipment, where that equipment falls within the scope of Regulation (EU) 2018/1139 of the European Parliament and of the Council ( 4 ) and is intended exclusively for airborne use:
aircraft, other than unmanned aircraft, as well as associated engines, propellers, parts and non-installed equipment;
unmanned aircraft, as well as associated engines, propellers, parts and non-installed equipment, the design of which is certified in accordance with Article 56(1) of that Regulation and which are intended to operate only on frequencies allocated by the Radio Regulations of the International Telecommunications Union for protected aeronautical use.
4. Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.
ANNEX Ia
SPECIFICATIONS AND INFORMATION RELATING TO CHARGING APPLICABLE TO CERTAIN CATEGORIES OR CLASSES OF RADIO EQUIPMENT
Part I
Specifications relating to charging capabilities
1. The requirements set out in points 2 and 3 of this Part shall apply to the following categories or classes of radio equipment:
2. In so far as they are capable of being recharged by means of wired charging, the categories or classes of radio equipment referred to in point 1 of this Part shall:
be equipped with the USB Type-C receptacle, as described in the standard ►M3 EN IEC 62680-1-3:2022 ◄ ‘Universal serial bus interfaces for data and power – Part 1-3: Common components – USB Type-C® Cable and Connector Specification’, and that receptacle shall remain accessible and operational at all times;
be capable of being charged with cables which comply with the standard ►M3 EN IEC 62680-1-3:2022 ◄ ‘Universal serial bus interfaces for data and power – Part 1-3: Common components – USB Type-C® Cable and Connector Specification’.
3. In so far as they are capable of being recharged by means of wired charging at voltages higher than 5 Volts, currents higher than 3 Amperes or powers higher than 15 Watts, the categories or classes of radio equipment referred to in point 1 of this Part shall:
incorporate the USB Power Delivery, as described in the standard ►M3 EN IEC 62680-1-2:2022 ◄ ‘Universal serial bus interfaces for data and power – Part 1-2: Common components – USB Power Delivery specification’;
ensure that any additional charging protocol allows for the full functionality of the USB Power Delivery referred to in point 3.1, irrespective of the charging device used.
Part II
Information on specifications relating to charging capabilities and the compatible charging devices
In the case of radio equipment falling within the scope of Article 3(4), first subparagraph, the following information shall be indicated in accordance with the requirements set out in Article 10(8), and may be made available in addition by means of QR codes or similar electronic solutions:
in the case of all categories or classes of radio equipment which are subject to the requirements set out in Part I, a description of the power requirements of the wired charging devices that can be used with that radio equipment, including the minimum power required to charge the radio equipment, and the maximum power required to charge the radio equipment at the maximum charging speed expressed in Watts by displaying the text: ‘the power delivered by the charger must be between min [xx] Watts required by the radio equipment, and max [yy] Watts in order to achieve the maximum charging speed’. The number of Watts shall express, respectively, the minimum power required by the radio equipment, and the maximum power required by the radio equipment to achieve the maximum charging speed;
in the case of radio equipment which is subject to the requirements set out in point 3 of Part I, a description of the specifications relating to charging capabilities of the radio equipment, in so far as it is capable of being recharged by means of wired charging at voltages higher than 5 Volts or currents higher than 3 Amperes or powers higher than 15 Watts, including an indication that the radio equipment supports the USB Power Delivery charging protocol by displaying the text ‘USB PD fast charging’ and an indication of any other supported charging protocol by displaying its name in text format.
Part III
Pictogram indicating whether or not a charging device is included with the radio equipment
1. The pictogram shall have the following formats:
If a charging device is included with the radio equipment:
If no charging device is included with the radio equipment:
2. The pictogram may vary in appearance (e.g. as to its colour, solid or hollow, line thickness), provided that it remains visible and legible. If the pictogram is reduced or enlarged, the proportions set out in the drawings in point 1 of this Part shall be maintained. The dimension ‘a’ referred to in point 1 of this Part shall be greater than or equal to 7 mm, irrespective of the variation.
Part IV
Content and format of the label
1. The label shall have the following format:
2. The letters ‘XX’ shall be replaced by the figure corresponding to the minimum power required by the radio equipment to charge, which determines the minimum power that a charging device needs to supply to charge the radio equipment. The letters ‘YY’ shall be replaced by the figure corresponding to the maximum power required by the radio equipment to achieve maximum charging speed, which determines the power that a charging device needs to supply at least to achieve that maximum charging speed. The abbreviation ‘USB PD’ (USB Power Delivery) shall be displayed if the radio equipment supports that charging communication protocol. ‘USB PD’ is a protocol that negotiates the fastest delivery of current from the charging device to the radio equipment without shortening the battery lifetime.
3. The label may vary in appearance (e.g. as to its colour, solid or hollow, line thickness), provided that it remains visible and legible. If the label is reduced or enlarged, the proportions set out in the drawing in point 1 of this Part shall be maintained. The dimension ‘a’ referred to in point 1 of this Part shall be greater than or equal to 7 mm, irrespective of the variation.
ANNEX II
CONFORMITY ASSESSMENT MODULE A
INTERNAL PRODUCTION CONTROL
1. |
Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 of this Annex, and ensures and declares on his sole responsibility that the radio equipment concerned satisfies the essential requirements set out in Article 3. |
2. |
Technical documentation
The manufacturer shall establish the technical documentation in accordance with Article 21. |
3. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured radio equipment with the technical documentation referred to in point 2 of this Annex and with the relevant essential requirements set out in Article 3. |
4. |
CE marking and EU declaration of conformity
4.1. The manufacturer shall affix the CE marking in accordance with Articles 19 and 20 to each item of radio equipment that satisfies the applicable requirements of this Directive. 4.2. The manufacturer shall draw up a written EU declaration of conformity for each radio equipment type and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The EU declaration of conformity shall identify the radio equipment for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
5. |
Authorised representative
The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
ANNEX III
CONFORMITY ASSESSMENT MODULES B AND C
EU-TYPE EXAMINATION AND CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
When reference is made to this Annex, the conformity assessment procedure shall follow Modules B (EU-type examination) and C (Conformity to type based on internal production control) of this Annex.
Module B
EU-type examination
1. |
EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of the radio equipment and verifies and attests that the technical design of the radio equipment meets the essential requirements set out in Article 3. |
2. |
EU-type examination shall be carried out by assessment of the adequacy of the technical design of the radio equipment through examination of the technical documentation and supporting evidence referred to in point 3, without examination of a specimen (design type). |
3. |
The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice. The application shall include:
(a)
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
(b)
a written declaration that the same application has not been lodged with any other notified body;
(c)
the technical documentation. The technical documentation shall make it possible to assess the radio equipment's conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the radio equipment. The technical documentation shall contain, wherever applicable, the elements set out in Annex V;
(d)
the supporting evidence for the adequacy of the technical design solution. That supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied or have not been fully applied. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility. |
4. |
The notified body shall examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the radio equipment. |
5. |
The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations as provided in point 8, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer. |
6. |
Where the type meets the requirements of this Directive that apply to the radio equipment concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the aspects of the essential requirements covered by the examination, the conditions (if any) for its validity and the necessary data for identification of the assessed type. The EU-type examination certificate may have one or more annexes attached. The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured radio equipment with the examined type to be evaluated and to allow for in-service control. Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal. |
7. |
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the radio equipment with the essential requirements of this Directive or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate. |
8. |
Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued. Each notified body shall inform the Member States of EU-type examination certificates it has issued and/or additions thereto in those cases where harmonised standards the references of which have been published in the Official Journal of the European Union have not been applied or not been fully applied. The Member States, the Commission and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Member States and the Commission may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer for 10 years after the radio equipment has been assessed or until the expiry of the validity of that certificate. |
9. |
The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. |
10. |
The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate. |
Module C
Conformity to type based on internal production control
1. |
Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares that the radio equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive that apply to it. |
2. |
Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured radio equipment with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to it. |
3. |
CE marking and EU declaration of conformity
3.1. The manufacturer shall affix the CE marking in accordance with Articles 19 and 20 to each item of radio equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive. 3.2. The manufacturer shall draw up a written EU declaration of conformity for each radio equipment type and keep it at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The EU declaration of conformity shall identify the radio equipment type for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
4. |
Authorised representative
The manufacturer's obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
ANNEX IV
CONFORMITY ASSESSMENT MODULE H
CONFORMITY BASED ON FULL QUALITY ASSURANCE
1. |
Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the radio equipment concerned satisfies the requirements of this Directive that apply to it. |
2. |
Manufacturing
The manufacturer shall operate an approved quality system for design, manufacture, final radio equipment inspection and testing of the radio equipment concerned as specified in point 3 and shall be subject to surveillance as specified in point 4. |
3. |
Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the radio equipment concerned. The application shall include:
(a)
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
(b)
the technical documentation for each radio equipment type intended to be manufactured. The technical documentation shall contain, wherever applicable, the elements set out in Annex V;
(c)
the documentation concerning the quality system; and
(d)
a written declaration that the same application has not been lodged with any other notified body. 3.2. The quality system shall ensure compliance of the radio equipment with the requirements of this Directive that apply to it. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of:
(a)
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;
(b)
the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential requirements of this Directive that apply to the radio equipment will be met;
(c)
the design control and design verification techniques, processes and systematic actions that will be used when designing radio equipment pertaining to the radio equipment type covered;
(d)
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
(e)
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
(f)
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.;
(g)
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. 3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard. In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant radio equipment field and radio equipment technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.1(b) to verify the manufacturer's ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the radio equipment with those requirements. The manufacturer or his authorised representative shall be notified of the decision. The notification shall contain the conclusions of the audit and the reasoned assessment decision. 3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient. 3.5. The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. |
4. |
Surveillance under the responsibility of the notified body
4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
(a)
the quality system documentation;
(b)
the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;
(c)
the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc. 4.3. The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. 4.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out radio equipment tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. |
5. |
CE marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking in accordance with Articles 19 and 20 and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each item of radio equipment that satisfies the applicable requirements set out in Article 3. 5.2. The manufacturer shall draw up a written EU declaration of conformity for each radio equipment type and keep it at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The EU declaration of conformity shall identify the radio equipment type for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request. |
6. |
The manufacturer shall, for a period ending 10 years after the radio equipment has been placed on the market, keep at the disposal of the national authorities:
(a)
the technical documentation referred to in point 3.1;
(b)
the documentation concerning the quality system referred to in point 3.1;
(c)
the change referred to in point 3.5, as approved;
(d)
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. |
7. |
Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. |
8. |
Authorised representative
The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. |
ANNEX V
CONTENTS OF TECHNICAL DOCUMENTATION
The technical documentation shall, wherever applicable, contain at least the following elements:
a general description of the radio equipment including:
photographs or illustrations showing external features, marking and internal layout;
versions of software or firmware affecting compliance with essential requirements;
user information and installation instructions;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the radio equipment;
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements set out in Article 3, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
copy of the EU declaration of conformity;
where the conformity assessment module in Annex III has been applied, copy of the EU-type examination certificate and its annexes as delivered by the notified body involved;
results of design calculations made, examinations carried out, and other relevant similar elements;
test reports;
an explanation of the compliance with the requirement of Article 10(2) and of the inclusion or not of information on the packaging in accordance with Article 10(10).
ANNEX VI
EU DECLARATION OF CONFORMITY (No XXX) ( 5 )
1. Radio equipment (product, type, batch or serial number):
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the declaration (identification of the radio equipment allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the radio equipment):
5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:
6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared. References must be listed with their identification number and version and, where applicable, date of issue:
7. Where applicable, the notified body … (name, number) … performed … (description of intervention) … and issued the EU-type examination certificate: …
8. Where applicable, description of accessories and components, including software, which allow the radio equipment to operate as intended and covered by the EU declaration of conformity:
9. Additional information:
ANNEX VII
SIMPLIFIED EU DECLARATION OF CONFORMITY
The simplified EU declaration of conformity referred to in Article 10(9) shall be provided as follows:
ANNEX VIII
CORRELATION TABLE
Directive 1999/5/EC |
This Directive |
Article 1 |
Article 1 |
Article 2 |
Article 2 |
Article 3(1) and (2) |
Article 3(1) and (2) |
Article 3(3) and Article 15a |
Article 3(3), with the exception of Article 3(3)(i), and Article 44 |
Article 4(1) and Articles 13 to 15 |
Articles 8 and 45 |
Article 4(2) |
— |
Article 5(1) |
Article 16 |
Article 5(2) and (3) |
— |
Article 6(1) |
Article 6 |
Article 6(2) |
— |
Article 6(3) |
Article 10(8), (9) and (10) |
Article 6(4) |
— |
Article 7(1) and (2) |
Article 7 |
Article 7(3), (4) and (5) |
— |
Article 8(1) and (2) |
Article 9 |
Article 8(3) |
— |
Article 9 |
Articles 39 to 43 |
Article 10 |
Article 17 |
Article 11 |
Articles 22 to 38 |
Article 12 |
Articles 19 and 20 and Article 10(6) and (7) |
Article 16 |
— |
Article 17 |
Article 47 |
Article 18 |
Article 48 |
Article 19 |
Article 49 |
Article 20 |
Article 50 |
Article 21 |
Article 51 |
Article 22 |
Article 52 |
Annex I |
Annex I |
Annex II |
Annex II |
Annex III |
— |
Annex IV |
Annex III |
Annex V |
Annex IV |
Annex VI |
Article 26 |
Annex VII(1) to (4) |
Articles 19 and 20 |
Annex VII(5) |
Article 10(10) |
STATEMENT OF THE EUROPEAN PARLIAMENT
The European Parliament considers that only when and insofar as implementing acts in the sense of Regulation (EU) No 182/2011 are discussed in meetings of committees, can the latter be considered as ‘comitology committees’ within the meaning of Annex I to the Framework Agreement on the relations between the European Parliament and the European Commission. Meetings of committees thus fall within the scope of point 15 of the Framework Agreement when and insofar as other issues are discussed.
( 1 ) Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (OJ L 108, 24.4.2002, p. 33).
( 2 ) OJ L 123, 12.5.2016, p. 1.
( 3 ) Council Directive 96/98/EC of 20 December 1996 on marine equipment (OJ L 46, 17.2.1997, p. 25).
( 4 ) Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).
( 5 ) It is optional for the manufacturer to assign a number to the EU declaration of conformity.