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 – UDI Device Requirements
May 2019
- Data Dictionary
- 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
If you require assistance with your preparation for MDR Eudamed, we provide support consultancy, support, and one day training courses. Training agendas: Technical and Non-Technical
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
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