RAC Regulatory Affairs Certification Exam

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Under the EU Medical Device Regulation (MDR 2017/745), which of the following BEST describes the purpose of the Post-Market Surveillance Report (PMSR)?

To provide a comprehensive summary of clinical investigation results for CE marking renewal. To fulfill marketing authorization requirements for the European Medicines Agency (EMA). To report all individual serious incidents to the competent authorities within 15 days. To summarize the results and conclusions of post-market surveillance data analysis primarily for Class I devices.

Correct Answer:

To summarize the results and conclusions of post-market surveillance data analysis primarily for Class I devices.

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