Article | April 22, 2021

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

Source: TransPerfect

By Adiba Kausar, Medical Writer, TransPerfect Life Sciences

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.


Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Leader