EC, 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 EUDAMED Updates

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

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

MDR, IVDR, and EUDAMED

June 2020

December 2019

May 2019

April 2019

March 2019

Please contact EudaMed.eu if you require assistance with your preparation for MDR EUDAMED, templates to help with the data preparation, support, consultancy, support, and one day training courses. Training agendas:  Technical and Non-Technical

UDI HRI & AIDC Formats

IFA

HIBCC

ICCBBA

GS1

MDCG Publications

2020

MDCG 2018-3 MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs
June 2020 Download

MDCG 2020-12 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 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 MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form

May 2020 Download

MDCG 2020-9 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 – 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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