European Commission, MDCG, and EUDAMED Updates

The European Commission publishes many artefacts relating to MDR EUDAMED and MDR templates, in addition to MDCG publications. We will maintain this list of updates so the latest information can be easily located by the MedTech industry (Page down).

European Commission MDR and IVDR EUDAMED Updates

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The following links and downloads are the European Commission published artefacts for MDCG, EUDAMED, and MDR, IVDR related templates.

Document sections: MDR, IVDR, and EUDAMED | MDCG | MIR

MDR, IVDR, and EUDAMED

July 2021

European Commission published an implementing act on harmonised standards for MDR (2017/745). Implementing act.

June 2021

European Commission publication on the European Medical Device Nomenclature (EMDN), questions and answers.

February 2021

August 2020

June 2020

December 2019

May 2019

April 2019

March 2019

Please contact Eudamed.com if you require assistance with your EUDAMED data preparations, software to help with the data preparation, support, consultancy, support, and training courses (agenda download).

UDI HRI & AIDC Formats

IFA

HIBCC

ICCBBA

GS1

MDCG Publications

MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system.
July 2021 Download

MDCG 2021-18 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)
July 2021 Download

MDCG 2021-17
MDCG 2021-17 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
July 2021 Download

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 Download

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 Download

MDCG 2021-14 Explanatory note on IVDR codes
July 2021 Download

MDCG 2021-13 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
June 2021 Download

MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN)
June 2021 Download

MDCG 2021-11 Guidance on Implant Card – Device types.
June 2021 Download

MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices.
June 2021 Download

MDCG 2021-9 MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers.
May 2021 Download

MDCG 2021-8 Clinical investigation application/notification documents. Also covers what to do in the absence of EUDAMED.
May 2021 Download

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 Download

MDCG 2018-1 Rev.4 Guidance on BASIC UDI-DI and changes to UDI-DI
April 2021 Download

MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
April 2021 Download

MDCG 2021-5 Guidance on standardisation for medical devices
April 2021 Download

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 Download

MDCG 2021 Is your software a medical device?
March 2021 Download

MDCG 2021-3 Questions and Answers on Custom-Made Devices
March 2021 Download

MDCG 2021-2 Guidance on the state of the art of COVID-19 rapid antibody tests
March 2021 Download

MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
March 2021 Download

2020

MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
December 2020 Download

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”
November 2020 Download

MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
November 2020 Download

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 Download

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 Download

MDCG 2019-15 rev.1 Guidance notes for manufacturers of Class I medical devices

July 2020 Download

MDCG 2020-2 rev.1 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)

July 2020 Download

MDCG 2019-16 rev.1 Guidance on Cybersecurity for medical devices

July 2020 Download

MDCG 2019-10 rev.1 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

July 2020 Download

MDCG 2020-13 Clinical evaluation assessment report template

July 2020 Download

MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs

June 2020 Download

MDCG 2020-12 Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues

June 2020 Download

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

May 2020 Download

MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745

May 2020 Download

MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form

May 2020 Download

MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories

May 2020 Download

MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies

April 2020 Download

MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies

April 2020 Download

MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies

April 2020 Download

MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies

April 2020 Download

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 Download

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 Download

MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)

March 2020 Download

MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
March 2020 Download

MDCG Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)

March 2020 Download

MDCG 2019-8 v2 Guidance document – Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices

March 2020  Download

MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI

March 2020 Download

2019

MDCG 2019-9 Summary of safety and clinical performance (SSCP) A guide for manufacturers and notified bodies (August 2019)

September 2019 SSCP Guide

MDCG 2019-10 Certificates MDD & MDR. Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

October 2019  Download

MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

October 2019 Download

MDCG 2019-12 Designating authority’s final assessment form: Key Information (EN)
October 2019 Download

MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation(EN)
December 2019 Download

MDCG 2019-14 Explanatory note on MDR codes (EN)
December 2019 Download

MDCG 2019-15 Guidance notes for manufacturers of Class I medical devices (EN)
December 2019 Download

MDCG 2019-16 Guidance on Cybersecurity for medical devices (EN)
January 2020 Download
June 2020 Download

Manufacturer Incident Report (MIR Form)

15th May 2020

30 September 2019

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