Periodic Safety Update Report: How do you write it without guidance?
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The Periodic Safety Update Report or "PSUR" is required by EU MDR for each Class IIa, IIb, and III device, and IVDR for Class C and D IVD's. It must be updated it at least every two years, for the lifetime of the device. The PSUR provides a comprehensive risk-benefit analysis with periodic updates, pulling data from multiple sources that may not be accustomed to interacting with each other in an efficient way (Risk Management, CER's, PMCF and PMS/Complaints).
The requirements in the regulation are new and seem to overlap with existing reports. We have yet to see any specific guidance or the PSUR template rumored to be in development and if SSCP and PMCF are any indication, it will be extensive. Where does that leave the industry on how far to go with data and analysis in the initial PSUR, what will be good enough to satisfy the notified bodies?
Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies.
Here's the panel:
Nancy Morrison – Exec. Director, Regulatory and Quality Consulting Services, and leader of R&Q EU MDR Leadership Council, R&Q
Jon Gimbel, Ph.D. – Executive Director, Regulatory and Quality Consulting Services, and technical leader of R&Q CER/PER team
Ron Sills – Senior Principal Specialist (Former TUV Rheinland Lead Auditor through 2019)
Celeste Maksim, Ph.D. – Principal Consultant, R&Q
Brian Hockett – Project Engineer, R&Q