EC MDR EUDAMED Updates

The European Commission publishes many artefacts relating to MDR EUDAMED and MDR templates. 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 MDR EUDAMED and MDR related templates.

MDR EUDAMED

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

Manufacturer Incident Report (MIR Form)

30 September 2019

MDCG Publications

2020

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

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

March 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 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 Cyber security for medical devices (EN)
January 2020 Download

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