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MDCG 2021-17
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MDCG 2021-17
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
July 2021
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
applicable for MDR IVDR
Applied-for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/745 (MDR)
| Name of the national authority responsible for notified bodies (DA) | |
|---|---|
| Name of the applicant conformity assessment body (CAB) and, if applicable, notified body's identification number | |
| Address of the CAB | |
| Date of application | |
I Codes reflecting the design and intended purpose of the device
Please mark the selected types of products and conformity assessment activities with a cross (X) in the grey coloured columns below. The different lists of codes are in accordance with the Implementing Regulation on the list of codes. Conformity assessment activities are identified by the corresponding reference to the Annex of the MDR.
The products and activities selected below will constitute the applied-for scope of application and therefore should be linked to the conformity assessment body's competence. Conditions, such as limitations must be included when applicable (e.g. when the competence cannot be justified for the whole code).
ACTIVE DEVICES
| MDA CODE | Active implantable devices | Annexes | Conditions | ||||
|---|---|---|---|---|---|---|---|
| IX(I) | IX(II) | X | XI(A) | XI(B) | |||
| 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 | ||||||
| MDA CODE | Active non-implantable devices for imaging, monitoring and / or diagnosis | Annexes | Conditions | ||||
| IX(I) | IX(II) | X | XI(A) | XI(B) | |||
| 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 | ||||||
| MDA CODE | Active non-implantable therapeutic devices and general active non-implantable devices | Annexes | Conditions | ||||
| IX(I) | IX(II) | X | XI(A) | XI(B) | |||
| 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 | ||||||
NON-ACTIVE DEVICES
| MDN CODE | Non-active implants and long term surgically invasive devices | Annexes | Conditions | ||||
|---|---|---|---|---|---|---|---|
| IX(I) | IX(II) | X | XI(A) | XI(B) | |||
| 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 | ||||||
| MDN CODE | Non-active non-implantable devices | Annexes | Conditions | ||||
|---|---|---|---|---|---|---|---|
| IX(I) | IX(II) | X | XI(A) | XI(B) | |||
| 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
Please mark the selected horizontal areas and technologies in the grey coloured columns below. The different lists of codes are in accordance with the Implementing Regulation on the list of codes.
The areas and technologies selected will be part of the applied-for scope of application and therefore each of these areas should be linked to the conformity assessment body's competence. Conditions, such as limitations must be included when applicable (e.g. when the competence cannot be justified for the whole code).
| MDS CODE | Devices with specific characteristics | Select | Conditions |
|---|---|---|---|
| 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 | ||
| MDS 1005 | Devices in sterile condition | Please indicate which of the following processes are covered: | |
| aseptic processing | |||
| ethylene oxide gas sterilisation (EOG) | |||
| low temperature steam and formaldehyde sterilisation | |||
| moist heat sterilisation | |||
| radiation sterilisation (gamma, x-ray, electron beam) | |||
| sterilisation with hydrogen peroxide | |||
| sterilisation with liquid chemical sterilising agents | |||
| thermic sterilisation with dry heat | |||
| Other sterilisation processes, please specify: If designation is sought also for other processes, these need to be specified. | |||
| 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 | ||
| MDT CODE | Devices for which specific technologies or processes are used | Select | Conditions |
|---|---|---|---|
| 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 |