Summary of Safety and Clinical Performance

10:00 AM - 10:50 AM

The Medical Device Regulations (MDR) introduces a new requirement under Article 32 – The Summary of Safety and Clinical Performance (SSCP). This new report is really the spirit of the MDR and aims to provide transparency to healthcare professionals and patients. This session will provide attendees with current experiences of the notified body’s validation of the SSCP, including common issues, good practice, and helpful information for medical writers to prepare their document for submission.

The objectives of this session include:

• Understanding the supporting MDCG Guidance for the SSCP (MDCG 2019-9)
• Knowing how and when to present the right information in the SSCP
• Methods for determining and validating the readability of the SSCP for patients.
• Understanding what other post-certification activities may trigger an update to the SSCP. (PSUR, PMCF)