European Commission MDR and IVDR EUDAMED Updates
Join our LinkedIn group to receive the latest updates.
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
February 2021
- Management of legacy devices
- Eudamed.eu free template to generate the EUDAMED DI codes
August 2020
June 2020
December 2019
May 2019
- MDR attributes
- IVDR attributes
- Data exchange services and entity models introductions
- M2M Data Exchange Services Definition
- Data exchange guidelines
- XSD – UDI Device
- UML Diagrams
- XML Samples
April 2019
March 2019
Please contact Eudamed.eu if you require assistance with your preparations for EUDAMED, 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 2021-5 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
- Manufacturer Incident Report 2020 (MIR Form) 7.2.1
- Manufacturer incident report for importing XML file with Adobe Professional 2020
- Changelog file 2020
- Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form
30 September 2019
- Manufacturer Incident Report 2020 (MIR Form)
- Manufacturer Incident Report Help text 2020
- Manufacturer Incident Report importing XML file with Adobe Professional 2020
- Manufacturer Incident Report change log file 2020
- MIR XSD’s