Essentials of European Medical Device Regulatory Affairs - October 2019

Vigilance

After the initial report….  Investigations by the manufacturer – Risk assessment – FSCA – Cooperation with CAs and NB  Upload Full report with conclusions and corrective actions  Send FSN to users – Devices (UDI) and Manufacturer (SRN)

– Reasons for the FSCA – Risks and level of risk – All actions to be taken by users – Translations(s)

 Upload FSN

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Today’s Objectives were... • To provide a basic understanding of European medical device regulatory requirements and how to ensure compliance

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