MDCG 2020-10 rev.1 Updates

The EU’s Medical Device Coordination Group (MDCG) has updated the previously released MDCG 2020-10 guidance on “Safety reporting in clinical investigations of medical devices” under the framework of the EU Medical Device Regulation 2017/745 (MDR); specifically governed by Article 80.

Rev. 1 introduces the following updates:

  • New definitions added.
  • Clarification on completing the reporting table.
  • Updates to the Reportable Events section:
    • Table has been updated.
    • 5.1: Reporting duties clarified.
  • Clarification on causality assessment, specifically on the causal relationship.
  • Coding has been added to the event details status.
  • New sections added:
    • 10.2.15: Device Issue.
    • 10.2.16: Clinical signs/symptoms.
    • 10.2.17: Clinical impact.
  • Clarification on:
    • 10.2.19: Relationship to procedure.
    • 10.2.20: Relationship to device.

You can access MDCG 2020-10 rev.1 here and the Excel Safety Report form here.