Medical Devices - Sector

Guidance - MDCG endorsed documents and other guidance

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This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. They are drafted in collaboration with interested parties represented in the various groups and denominated by the following format: “MDCG Year-Number-revision”.

The documents on this page are not legally binding. They present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonised implementation of the legislation.

MDCG work in progress

Ongoing guidance documents

Borderline and Classification

Reference Title Publication

Helsinki Procedure

 Helsinki Procedure for borderline and classification under MDR & IVDR September 2021

Clinical investigation and evaluation

Reference Title Publication

MDCG 2021-20

 Instructions for generating CIV-ID for MDR Clinical Investigations July 2021

MDCG 2021-8

 Clinical investigation application/notification documents May 2021

MDCG 2021-6

 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation April 2021

MDCG 2020-13 - Word version

 Clinical evaluation assessment report template July 2020
MDCG 2020-10/2

MDCG 2020-10/1

 Guidance on safety reporting in clinical investigations
Appendix: Clinical investigation summary safety report form		 May 2020
May 2020
MDCG 2020-8 Guidance on PMCF evaluation report template April 2020
MDCG 2020-7 Guidance on PMCF plan template April 2020
MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices April 2020
MDCG 2020-5 Guidance on clinical evaluation – Equivalence April 2020
MDCG 2019-9 Summary of safety and clinical performance August 2019

COVID-19

Reference Title Publication
MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices August 2021
MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices May 2021
MDCG 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests March 2021
COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 February 2021
Conformity assessment procedures for protective equipment July 2020
How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context May 2020
Guidance on regulatory requirements for medical face masks June 2020
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context April 2020
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19 April 2020
MDCG 2020-9 Regulatory requirements for ventilators and related accessories April 2020

Custom-Made Devices

Reference Title Publication
MDCG 2021-3 Questions and Answers on Custom-Made Devices March 2021

EUDAMED

Reference Title Publication
MDCG 2021-13 Rev. 1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR July 2021
MDCG 2021-1 Rev. 1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional May 2021
MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States August 2020
MDCG 2019-5 Registration of legacy devices in EUDAMED April 2019
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED April 2019

European Medical Device Nomenclature (EMDN)

Reference Title Publication
MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN) June 2021
The EMDN – The nomenclature of use in EUDAMED January 2020
The CND nomenclature – Background and general principles January 2020

Implant cards

Reference Title Publication
MDCG 2021-11 Guidance on Implant Card – Device types May 2021
MDCG 2019-8 v2 Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices March 2020

In Vitro Diagnostic medical devices (IVD)

Reference Title Publication
MDCG 2021-22 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 August 2021
MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 April 2021
MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 November 2020

New technologies

Reference Title Publication
Infographic Is your software a Medical Device? March 2021
MDCG 2020-1 Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software March 2020
MDCG 2019-16 rev.1 Guidance on cybersecurity for medical devices December 2019
MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 October 2019

Notified bodies

Reference Title Publication
MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 August 2021
MDCG 2021-18 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) July 2021
MDCG 2021-17 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) July 2021
MDCG 2021-16 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) July 2021
MDCG 2021-15 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) July 2021
MDCG 2021-14 Explanatory note on IVDR codes July 2021
MDCG 2020-17 Questions and Answers related to MDCG 2020-4:
“Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”		 December 2020
MDCG 2020-14 Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) August 2020
MDCG 2020-12 Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues June 2020
MDCG 2020-11 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 May 2020
MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions April 2020
MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD March 2020
MDCG 2019-14 Explanatory note on MDR codes December 2019
MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation December 2019
MDCG 2019-12 Designating authority's final assessment form: Key information (EN) October 2019
MDCG 2019-10 rev.1 Application of transitional provisions concerning validity of certificates issued in accordance to the directives October 2019
MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies October2019
MDCG 2018-8 Guidance on content of the certificates, voluntary certificate transfers November 2018
NBOG BPG 2017-2 Best practice guidance on the information required for personnel involved in conformity assessment February 2018
NBOG BPG 2017-1 Best practice guidance on designation and notification of conformity assessment bodies February 2018
NBOG F 2017-8 Review of qualification for the authorisation of personnel (IVDR) February 2018
NBOG F 2017-7 Review of qualification for the authorisation of personnel (MDR) February 2018
NBOG F 2017-6 Preliminary assessment review template (IVDR) February 2018
NBOG F 2017-5 Preliminary assessment review template (MDR) February 2018

Standards

Reference Title Publication
MDCG 2021-5 Guidance on standardisation for medical devices April 2021

Unique Device Identifier (UDI)

Reference Title Publication
MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system July 2021
MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices June 2021
MDCG 2021-09 MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers May 2021
MDCG 2018-1 Rev. 4 Guidance on basic UDI-DI and changes to UDI-DI April 2021
MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers December 2020
MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017 February 2019
MDCG 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI January 2019
MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database October 2018
MDCG 2018-6 Clarifications of UDI related responsibilities in relation to article 16 October 2018
MDCG 2018-5 UDI assignment to medical device software October 2018
MDCG 2018-4 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs October 2018
MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs June 2020
MDCG 2018-2 Future EU medical device nomenclature - Description of requirements March 2018

Other topics

Reference Title Publication
MDCG 2020-2 rev.1 Class I transitional provisions under Article 120 (3 and 4) – (MDR) March 2020
MDCG 2019-15 rev.1 Guidance notes for manufacturers of class I medical devices December 2019
MDCG 2019-7 Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) June 2019
MDCG 2019-3 rev.1 Interpretation of article 54(2)b April 2020

Other guidance documents

Reference Title Publication
European Medicines Agency (EMA) Guidance Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) June 2021
SCHEER guidelines Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices
covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties		 June 2019
CAMD FAQ CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions January 2018