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).