Summary of Safety and Clinical Performance
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The Summary of Safety and Clinical Performance or "SSCP" is required by EU MDR for Class III and implantable devices. The SSCP must be reviewed every year, for the lifetime of the device, and is a public facing document. The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device.
The MDCG 2019-9 guidance calls for significant detail that device manufacturers would prefer to keep confidential. As a result, creating an SSCP that meets the regulatory requirements and is acceptable to the Marketing and Legal teams is incredibly challenging. Further complications are having an SSCP that's suitable for patient review, providing multiple translations, and updating this long and comprehensive document annually.
R&Q has submitted multiple SSCPs and received notified body feedback. Join our experts in a discussion of best practices we've seen so far and what we're hearing from the notified bodies.
Ibim Tariah, Ph.D. – VP of EU MDR and IVDR Consulting Services, R&Q (Former BSI Technical Director of Medical Devices through 2019; 21 years at BSI)
Amie Smirthwaite, Ph.D. – Head of Global Clinical Practice, Maetrics (recent Head of Global Clinical at BSI)
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, R&Q