Solutions Circle 2: The Summary of Safety and Clinical Performance: Enhancing Transparency and Empowering Patients

Description: The European Medical Devices Regulation 2017/745 (EU MDR) requires a Summary of Safety and Clinical Performance (SSCP) for Class III and Implantable devices. 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. Transparency and access to information are key principles of the EU MDR and are encapsulated in Recital 43:

“(43) Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.”

The requirements of the SSCP are specified in Article 32 of the EU MDR and further guidance is provided in MDCG 2019-9 Summary of safety and clinical performance – A guide for manufacturers and notified bodies. MDCG 2019-9 is intended to provide guidance on the requirement for updates, notified body validation, availability in Eudamed and translation, as well as structure, content and stylistic recommendations. However, experiences so far point to an administrative burden for both regulators and manufacturers, with the guidance going beyond the requirements of the MDR. As such, updates to MDCG2019-9 have been eagerly anticipated.

This Solutions Circle provides participants the opportunity to share practical experiences and discuss best practices for writing SSCPs, as well as participate in knowledge sharing on topics such as managing updates, determining the level of information required and assessing readability of the patient SSCP.