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
- 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 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
- Manufacturer Incident Report 2020 (MIR Form)
- Manufacturer Incident Report Helptext 2020
- Manufacturer Incident Report importing XML file with Adobe Professional 2020
- Manufacturer Incident Report change log file 2020
- MIR XSD’s
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