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

December 2019

• Data Dictionary V5

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

• MDCG 2019-5 Registration of legacy devices in EUDAMED

March 2019

• Medical Devices Nomenclature
• Eudamed Functional Specifications

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

• • Basic UDI-DI
  • UDI HRI & AIDC Formats

HIBCC

• • Basic UDI-DI
  • UDI HRI & AIDC Formats

ICCBBA

• • Basic UDI-DI
  • UDI HRI & AIDC Formats

GS1

• • Basic UDI-DI
  • UDI HRI & AIDC Formats

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

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