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Document 32017R2185

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Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council (Text with EEA relevance. )

C/2017/7779
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OJ L 309, 24.11.2017, p. 7–17 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

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24.11.2017   

EN

Official Journal of the European Union

L 309/7


COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185

of 23 November 2017

on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (1), and in particular Articles 39(10) and 42(13) thereof,

Having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (2), and in particular Articles 35(10) and 38(13) thereof,

Whereas:

(1)

Conformity assessment of medical devices under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may require involvement of conformity assessment bodies. Only conformity assessment bodies that have been designated under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 may carry out such assessment and only for the activities related to the types of devices concerned. In order to enable specifying the scope of the designation of conformity assessment bodies notified under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 it is necessary to draw up list of codes and corresponding types of devices.

(2)

The lists of codes and corresponding types of devices should take into account various device types which can be characterised by design and intended purpose, manufacturing processes and technologies used, such as sterilisation and the use of nanomaterials. The lists of codes should provide for a multi-dimensional typology of devices which ensures that conformity assessment bodies designated as notified bodies are fully competent for the devices they are required to assess.

(3)

In accordance with Article 42(3) of Regulation (EU) 2017/745 and Article 38(3) of Regulation (EU) 2017/746, when notifying the Commission and the other Member States of the conformity assessment bodies they have designated Member States are to clearly specify, using the codes, the scope of the designation indicating the conformity assessment activities and the types of devices which the notified body is authorised to assess. In order to facilitate such notification and the assessment of the application for designation referred to in Article 38 of Regulation (EU) 2017/745 and Article 34 of Regulation (EU) 2017/746, conformity assessment bodies should use the lists of codes and corresponding types of devices set out in this Regulation when applying for designation.

(4)

Experience shows that conformity assessment bodies applying for designation in the field of in vitro diagnostic medical devices also apply for designation for medical devices under Regulation (EU) 2017/745. It is therefore appropriate, for reasons of user-friendliness, to include the lists of codes for Regulation (EU) 2017/745 and for Regulation (EU) 2017/746 in one Implementing Regulation.

(5)

As of 26 November 2017, conformity assessment bodies may submit an application for designation as a notified body under Regulation (EU) 2017/745 and Regulation (EU) 2017/746. In order to enable the conformity assessment bodies to use the codes laid down in this Regulation in the application for designation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices,

HAS ADOPTED THIS REGULATION:

Article 1

List of codes

1.   The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 is set out in Annex I to this Regulation.

2.   The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746 is set out in Annex II to this Regulation.

Article 2

Application for designation

Conformity assessment bodies shall use the lists of codes and corresponding types of devices set out in Annexes I and II to this Regulation when specifying the types of devices in the application for designation referred to in Article 38 of Regulation (EU) 2017/745 and Article 34 of Regulation (EU) 2017/746.

Article 3

Entry into force

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 23 November 2017.

For the Commission

The President

Jean-Claude JUNCKER


(1)  OJ L 117, 5.5.2017, p. 1.

(2)  OJ L 117, 5.5.2017, p. 176.


ANNEX I

The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745

I.   CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE

A.   Active devices

1.   Active implantable devices

MDA CODE

Active implantable devices

MDA 0101

Active implantable devices for stimulation/inhibition/monitoring

MDA 0102

Active implantable devices delivering drugs or other substances

MDA 0103

Active implantable devices supporting or replacing organ functions

MDA 0104

Active implantable devices utilising radiation and other active implantable devices

2.   Active non-implantable devices for imaging, monitoring and/or diagnosis

MDA CODE

Active non-implantable devices for imaging, monitoring and/or diagnosis

MDA 0201

Active non-implantable imaging devices utilising ionizing radiation

MDA 0202

Active non-implantable imaging devices utilising non-ionizing radiation

MDA 0203

Active non-implantable devices for monitoring of vital physiological parameters

MDA 0204

Other active non-implantable devices for monitoring and/or diagnosis

3.   Active non-implantable therapeutic devices and general active non-implantable devices

MDA CODE

Active non-implantable therapeutic devices and general active non-implantable devices

MDA 0301

Active non-implantable devices utilising ionizing radiation

MDA 0302

Active non-implantable devices utilising non-ionizing radiation

MDA 0303

Active non-implantable devices utilising hyperthermia/hypothermia

MDA 0304

Active non-implantable devices for shock-wave therapy (lithotripsy)

MDA 0305

Active non-implantable devices for stimulation or inhibition

MDA 0306

Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis

MDA 0307

Active non-implantable respiratory devices

MDA 0308

Active non-implantable devices for wound and skin care

MDA 0309

Active non-implantable ophthalmologic devices

MDA 0310

Active non-implantable devices for ear, nose and throat

MDA 0311

Active non-implantable dental devices

MDA 0312

Other active non-implantable surgical devices

MDA 0313

Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport

MDA 0314

Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

MDA 0315

Software

MDA 0316

Medical gas supply systems and parts thereof

MDA 0317

Active non-implantable devices for cleaning, disinfection and sterilisation

MDA 0318

Other active non-implantable devices

B.   Non-active devices

1.   Non-active implants and long term surgically invasive devices

MDN CODE

Non-active implants and long term surgically invasive devices

MDN 1101

Non-active cardiovascular, vascular and neurovascular implants

MDN 1102

Non-active osteo- and orthopaedic implants

MDN 1103

Non-active dental implants and dental materials

MDN 1104

Non-active soft tissue and other implants

2.   Non-active non-implantable devices

MDN CODE

Non-active non-implantable devices

MDN 1201

Non-active non-implantable devices for anaesthesia, emergency and intensive care

MDN 1202

Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis

MDN 1203

Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools

MDN 1204

Non-active non-implantable devices for wound and skin care

MDN 1205

Non-active non-implantable orthopaedic and rehabilitation devices

MDN 1206

Non-active non-implantable ophthalmologic devices

MDN 1207

Non-active non-implantable diagnostic devices

MDN 1208

Non-active non-implantable instruments

MDN 1209

Non-active non-implantable dental materials

MDN 1210

Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases

MDN 1211

Non-active non-implantable devices for disinfecting, cleaning and rinsing

MDN 1212

Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

MDN 1213

Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route

MDN 1214

General non-active non-implantable devices used in health care and other non-active non-implantable devices

II.   HORIZONTAL CODES

1.   Devices with specific characteristics

MDS CODE

Devices with specific characteristics

MDS 1001

Devices incorporating medicinal substances

MDS 1002

Devices manufactured utilising tissues or cells of human origin, or their derivatives

MDS 1003

Devices manufactured utilising tissues or cells of animal origin, or their derivatives

MDS 1004

Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1)

MDS 1005

Devices in sterile condition

MDS 1006

Reusable surgical instruments

MDS 1007

Devices incorporating or consisting of nanomaterial

MDS 1008

Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body

MDS 1009

Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices

MDS 1010

Devices with a measuring function

MDS 1011

Devices in systems or procedure packs

MDS 1012

Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

MDS 1013

Class III custom-made implantable devices

MDS 1014

Devices incorporating as an integral part an in vitro diagnostic device

2.   Devices for which specific technologies or processes are used

MDT CODE

Devices for which specific technologies or processes are used

MDT 2001

Devices manufactured using metal processing

MDT 2002

Devices manufactured using plastic processing

MDT 2003

Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)

MDT 2004

Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)

MDT 2005

Devices manufactured using biotechnology

MDT 2006

Devices manufactured using chemical processing

MDT 2007

Devices which require knowledge regarding the production of pharmaceuticals

MDT 2008

Devices manufactured in clean rooms and associated controlled environments

MDT 2009

Devices manufactured using processing of materials of human, animal, or microbial origin

MDT 2010

Devices manufactured using electronic components including communication devices

MDT 2011

Devices which require packaging, including labelling

MDT 2012

Devices which require installation, refurbishment

MDT 2013

Devices which have undergone reprocessing


(1)  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ L 157, 9.6.2006, p. 24).


ANNEX II

The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746

I.   CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE

1.   Devices intended to be used for blood grouping

IVR CODE

Devices intended to be used to determine markers of the specific blood grouping systems to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration

IVR 0101

Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)]

IVR 0102

Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]

IVR 0103

Devices intended to determine markers of the Kell system [Kel1 (K)]

IVR 0104

Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)]

IVR 0105

Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)]

 

Other devices intended to be used for blood grouping

IVR 0106

Other devices intended to be used for blood grouping

2.   Devices intended to be used for tissue typing

IVR CODE

Devices intended to be used for tissue typing

IVR 0201

Devices intended to be used for tissue typing (HLA A, B, DR) to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration

IVR 0202

Other devices intended to be used for tissue typing

3.   Devices intended to be used for markers of cancer and non-malignant tumours

IVR CODE

Devices intended to be used for markers of cancer and non-malignant tumours except devices for human genetic testing

IVR 0301

Devices intended to be used in screening, diagnosis, staging or monitoring of cancer

IVR 0302

Other devices intended to be used for markers of cancer and non-malignant tumours

4.   Devices intended to be used for human genetic testing

IVR CODE

Devices intended to be used for human genetic testing

IVR 0401

Devices intended to be used in screening/confirmation of congenital/inherited disorders

IVR 0402

Devices intended to be used to predict genetic disease/disorder risk and prognosis

IVR 0403

Other devices intended to be used for human genetic testing

5.   Devices intended to be used to determine markers of infections/immune status

IVR CODE

Devices intended to be used for the screening, confirmation, identification of infectious agents or determination of immune status

IVR 0501

Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents

IVR 0502

Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration

IVR 0503

Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents

IVR 0504

Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging

IVR 0505

Devices intended to be used to grow/isolate/identify and handle infectious agents

IVR 0506

Other devices intended to be used to determine markers of infections/immune status

6.   Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures

IVR CODE

Devices intended to be used for a specific disease

IVR 0601

Devices intended to be used for screening/confirmation of specific disorders/impairments

IVR 0602

Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease

IVR 0603

Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances

IVR 0604

Other devices intended to be used for a specific disease

 

Devices intended to be used to define or monitor physiological status and therapeutic measures

IVR 0605

Devices intended to be used for monitoring of levels of medicinal products, substances or biological components

IVR 0606

Devices intended to be used for non-infectious disease staging

IVR 0607

Devices intended to be used for detection of pregnancy or fertility testing

IVR 0608

Devices intended to be used for screening, determination or monitoring of physiological markers

IVR 0609

Other devices intended to be used to define or monitor physiological status and therapeutic measures

7.   Devices which are controls without a quantitative or qualitative assigned value

IVR CODE

Controls without a quantitative or qualitative assigned value

IVR 0701

Devices which are controls without a quantitative assigned value

IVR 0702

Devices which are controls without a qualitative assigned value

8.   Class A devices in sterile condition

IVR CODE

Class A devices in sterile condition

IVR 0801

Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746

IVR 0802

Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746

IVR 0803

Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746

II.   HORIZONTAL CODES

1.   In vitro diagnostic devices with specific characteristics

IVS CODE

In vitro diagnostic devices with specific characteristics

IVS 1001

Devices intended to be used for near-patient testing

IVS 1002

Devices intended to be used for self-testing

IVS 1003

Devices intended to be used as companion diagnostics

IVS 1004

Devices manufactured utilising tissues or cells of human origin, or their derivatives

IVS 1005

Devices in sterile condition

IVS 1006

Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746)

IVS 1007

Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (point 1.6 of Annex VIII to Regulation (EU) 2017/746)

IVS 1008

Instruments, equipment, systems or apparatus

IVS 1009

Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures

IVS 1010

Devices incorporating software/utilising software/controlled by software

2.   In vitro diagnostic devices for which specific technologies are used

IVT CODE

In vitro diagnostic devices for which specific technologies are used

IVT 2001

In vitro diagnostic devices manufactured using metal processing

IVT 2002

In vitro diagnostic devices manufactured using plastic processing

IVT 2003

In vitro diagnostic devices manufactured using non-metal mineral processing (e.g. glass, ceramics)

IVT 2004

In vitro diagnostic devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)

IVT 2005

In vitro diagnostic devices manufactured using biotechnology

IVT 2006

In vitro diagnostic devices manufactured using chemical processing

IVT 2007

In vitro diagnostic devices which require knowledge regarding the production of pharmaceuticals

IVT 2008

In vitro diagnostic devices manufactured in clean rooms and associated controlled environments

IVT 2009

In vitro diagnostic devices manufactured using processing of materials of human, animal or microbial origin

IVT 2010

In vitro diagnostic devices manufactured using electronic components including communication devices

IVT 2011

In vitro diagnostic devices which require packaging, including labelling

3.   In vitro diagnostic devices which require specific knowledge in examination procedures for the purpose of product verification

IVP CODE

In vitro diagnostic devices which require specific knowledge in examination procedures

IVP 3001

In vitro diagnostic devices which require knowledge regarding agglutination tests

IVP 3002

In vitro diagnostic devices which require knowledge regarding biochemistry

IVP 3003

In vitro diagnostic devices which require knowledge regarding chromatography

IVP 3004

In vitro diagnostic devices which require knowledge regarding chromosomal analysis

IVP 3005

In vitro diagnostic devices which require knowledge regarding coagulometry

IVP 3006

In vitro diagnostic devices which require knowledge regarding flow cytometry

IVP 3007

In vitro diagnostic devices which require knowledge regarding immunoassays

IVP 3008

In vitro diagnostic devices which require knowledge regarding lysis based testing

IVP 3009

In vitro diagnostic devices which require knowledge regarding measurement of radioactivity

IVP 3010

In vitro diagnostic devices which require knowledge regarding microscopy

IVP 3011

In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS)

IVP 3012

In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry

IVP 3013

In vitro diagnostic devices which require knowledge regarding spectroscopy

IVP 3014

In vitro diagnostic devices which require knowledge regarding tests of cell function

4.   In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification

IVD CODE

In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification

IVD 4001

In vitro diagnostic devices which require knowledge regarding bacteriology

IVD 4002

In vitro diagnostic devices which require knowledge regarding clinical chemistry/biochemistry

IVD 4003

In vitro diagnostic devices which require knowledge regarding detection of transmissible agents (without organisms or viruses)

IVD 4004

In vitro diagnostic devices which require knowledge regarding genetics

IVD 4005

In vitro diagnostic devices which require knowledge regarding haematology/haemostasis, including coagulation disorders

IVD 4006

In vitro diagnostic devices which require knowledge regarding histocompatibility and immunogenetics

IVD 4007

In vitro diagnostic devices which require knowledge regarding immunohistochemistry/histology

IVD 4008

In vitro diagnostic devices which require knowledge regarding immunology

IVD 4009

In vitro diagnostic devices which require knowledge regarding molecular biology/diagnostics

IVD 4010

In vitro diagnostic devices which require knowledge regarding mycology

IVD 4011

In vitro diagnostic devices which require knowledge regarding parasitology

IVD 4012

In vitro diagnostic devices which require knowledge regarding virology


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