The webinar will provide an in-depth exploration of Post-Market Surveillance (PMS), starting from the requirements necessary to ensure compliance with the MDR.

We will examine the key responsibilities of manufacturers, the expectations of a Notified Body such as BSI with respect to a PMS Plan, and how tools such as the interactive dedicated review enable effective exchange and clarification of the Notified Body’s requirements.

Topics will include the Periodic Safety Update Report (PSUR), the Summary of Safety and Clinical Performance (SSCP), as well as Post-Market Clinical Follow-up (PMCF) activities, with a particular focus on the collection of clinical data and/or clinical studies in accordance with the MDR.

Through this session, which will draw extensively on the Regulation and related guidance documents, manufacturers will gain an in-depth understanding useful for the preparation of robust and compliant technical documentation.