SSCP – The Challenge of Determining Frequencies of Side Effects and Residual Risks in Medical Devices

Description The Summary of Safety and Clinical Performance (SSCP) is a critical document for high-risk and implantable medical devices under the EU Medical Device Regulation (MDR). The SSCP provides public access to device-specific clinical data on the safety and the intended clinical benefit of the medical device. A quantification of side effects and residual risks in terms of frequency over time is recommended by MDCG 2019-9 and enforced by notified bodies. This means rates or frequencies need to be provided (e.g., "occurs in 2% of patients per year"). The guidance also recognizes that not everything can be precisely quantified-especially rare events or those for which clinical data are limited. However, a plethora of questions are left in the open:

- How to prove that data are limited, and the risk cannot be quantified?

- What are possible literature search strategies?

- Do similar devices and other indications need to be included as well?

- To what extend can data on similar devices or other indication be leveraged for extrapolation?

- What is the appropriate depth of the search - for example, should it extend to device components or materials?

- Can AI be used to estimate numbers?

This session aims to address those questions and illustrate the pathway from manufacturer to consultant to the notified body by discussing real-life experiences and challenges.