The Summary Of Safety And Clinical Performance (SSCP) For Healthcare Professionals And Patients

In 2017, the European Parliament and the Council of the European Union (EU) set a regulatory upgrade on medical devices to strengthen governance structure. This regulation update includes increased oversight of notified bodies, new requirements for transparency and traceability, and revised practices for clinical investigations, vigilance, and post-market surveillance.

While the new regulations on medical devices (MDR: Regulation [EU] 2017/745) and in vitro diagnostics (IVDR: Regulation [EU] 2017/746) aim to reduce risks associated with medical devices, their implementation calls for a focused effort from device manufacturers.

The COVID-19 pandemic delayed the enforcement of the MDR legislation until May 26, 2021. However, the transition is forcing manufacturers to make decisions to prepare for the new requirements.

One particular document presents a challenge for manufacturers, since they will need to consider patients a target audience. Article 32 of the MDR requires creating a summary of safety and clinical performance (SSCP), which device manufacturers will need to prepare annually to remain in compliance with the regulation.