Summary of Safety and Clinical Performance (SSCP): 5 Challenges to be met

The Summary of Safety and Clinical Performance (SSCP) is a requirement under the Regulation (EU) 2017/745 for class III and implantable devices other than custom-made or investigational devices. The requirement is outlined in article 32 of the Medical Device Regulation (MDR) along with some of the expectations for content. The SSCP is available to the public via the EU database system EUDAMED. The EU medical device regulators have implemented this requirement to allow public access to up-to-date clinical safety and performance data for higher risk devices. The intention is to provide patients, healthcare providers, and the public a summary of the clinical data, thus enhancing transparency and creating a higher level of confidence in the clinical data on which CE Mark decisions are based.

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