Clinical investigations under the MDR: New Revision of MDCG on Safety reporting

The Medical Devices Coordination Group (MDCG) released on October 2022 a new revision to their MDCG guidance on safety reporting in clinical investigations of medical devices under Regulation (EU) 2017/745. This guidance addresses the circumstances under which safety reporting should be carried out and what the report should include. As this guidance is already covered in our previous post, we will address the main changes stated under the new revision:

  • New definitions in Section 3 on:
    • Incident
    • New Finding
    • Serious Adverse Device Effect (SADE)
    • Serious incident
    • Unanticipated serious adverse device effect (USADE)
  • Clarifications on filling in the reporting table (Section 4)
  • The table on Reportable events has been updated, and reporting duties have been clarified (Section 5)
  • The section on casuality assessment has been clarified (Section 9.4)
  • Reporting form guideline has included coding (Section 10.2.1)
  • Sections of the Reporting form have been added (Sections 10.2.15-17):
    • Device issue (if applicable)
    • Clinical Signs/Symptoms
    • Clinical impact
  • New clarifications included in Section 10.2.19-20

Moreover, the Clinical Investigation Summary Safety Report is available as an Appendix to the guidance.

We will keep you informed about any further updates in our News section.

More information on Clinical investigations can be found in MDlaw Library of Documents.

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