The Periodic Safety Update Report (PSUR) is an entirely new type of report that has been introduced in Article 86 of the Medical Device Regulation (MDR).
It requires manufacturer of class IIa, class IIb and class III devices to prepare a Periodic Safety Update Report (PSUR) for each device and where relevant for each category or group of devices summarizing the results and conclusions of the analyses of the PMS data gathered.
The regulatory requirement is set, yet the PSUR is a new document and manufacturers often do not have a clear view of what it entails:
- What do MDCG guidelines say?
- What are the expected data sources that need to be analysed and presented?
- Which type of preventive and corrective actions need to be listed in the PSUR?
- What are the main findings that should come out of the PSUR?
- Where does it fit within the PMS context and other post-market documents such as the PMCF Evaluation Report, the CER and the SSCP?
This workshop will provide relevant information to draft a PSUR, including what data should be presented and how it should be reported. It will offer the experience of an industry-expert for all representatives involved in working with medical devices under the MDR umbrella.