Module 16 2022

07/09/2022

Questions to be asked

 Should the incident be reported to a Competent Authority?

 Should a Vigilance Incident report be made and indicate whether it leads to :- Field Safety Corrective action (FSCA) notified via a Field safety Notice (FSN)?

 Which Competent Authority should be notified?

 What is the timescale for the report?(also refer to MDR Art 87)

 What additional information is needed before a decision can be taken?

 What reference to regulation or guidance should be made?

The Organisation for Professionals in Regulatory Affairs

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Regulatory Background Potential Considerations

• The National Competent Authorities of all affected EEA Member States plus Switzerland and UK • The Notified Bodies/UK Approved Bodies • MedTech Europe • Role of Manufacturer • Role of Authorised Representative and its communications with a manufacturer based outside the EU • Role of Wholly owned Subsidiaries • Role of Independent Distributors • Official Guidance

The Organisation for Professionals in Regulatory Affairs

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