EC 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

• MDCG 2019-5 Registration of legacy devices in EUDAMED

March 2019

• Medical Devices Nomenclature
• Eudamed Functional Specifications

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

Certificates MDD & MDR

04 October 2019

• EC & MDCG 2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC  Download

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

Qualification and Classification of Software

MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

October 2019

• Guidance

Summary of safety and clinical performance (SSCP)

MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies (August 2019)

September 2019

• SSCP Guide