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.
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