MDCG 2023-3 Guidance has been published

MDCG 2023-3-The guidance document on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices has been published by MDCG.

The purpose of this guidance is to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). This guidance enlightens competent authorities, economic operators and other relevant parties on establisment a common understanding of these terms and concepts is necessary for an effective and harmonised implementation of the vigilance requirements under the MDR.

This guidance includes the followings:

  • Definition of incident, serious incident,use error, undesirable side affect, user,user error abnormal use,use-error due to ergonomic features, field safety corrective action (FSCA), Periodic Summary Report’etc.,
  • Reportability under the MDR,
  • Criteria for a serious incident and examples of some of serious incident,
  • Examples of incidents that indirectly lead to serious deterioration of health,
  • Examples of malfunction and deterioration in the characteristics or performance of a device,
  • Serious incident reporting requirements and timelines defined by Article 87(3) to (5) MDR,
  • Manufacturer awareness date on the timeline of a serious incident and examples
  • The report type Final (Non-reportable incident),
  • FSCA (Field safety corrective action) examples,
  • Field safety corrective action undertaken in a third country and examples,
  • Analysis of serious incidents and field safety corrective actions and related competent authorities,
  • Information on vigilance reporting in Eudamed,
  • Manufacturers, importers and distributors requirement to inform competent authorities of devices that present or are considered to present a serious risk,
  • Periodic Summary Report (PSR),
  • Criteria for a ‘common and well documented’ serious incident.

You can contact our team to get detailed information about Vigilance Requirements under MDR.