Summary of Safety and Clinical Performance (SSCP) for Medical Devices

The SSCP is a publicly available document summarizing safety and performance data on a medical device. It is intended to provide valuable information to healthcare professionals and patients. As outlined in Article 32 of the Medical Device Regulation (MDR 2017/745), manufacturers of Class III and implantable devices are required to submit an SSCP to the Notified Body (NB), as part of the documentation for conformity assessment.   

In this blog post, we will explore the SSCP requirements, content, how to write the patient-specific section, readability assessment, and the validation process.  

Conducting MDR-compliant Clinical Evaluations for Medical Devices

Clinical evaluation is a systematic process used to appraise and analyze clinical data related to a medical device. It compiles all available clinical evidence available to demonstrate compliance with regulatory requirements. The framework for conducting a clinical evaluation is outlined in Annex XIV, Part A of the European Medical Device Regulation (EU MDR) 2017/745.

The central role of literature review for medical devices under the MDR.

Within the medical device industry, the European Medical Device Regulations (MDR) 2017/745 has introduced new challenges, increasing the scrutiny of the regulatory documentation and imposing stricter requirements for approving medical devices in the EU market. The MDR emphasizes the need for substantial clinical evidence to demonstrate conformity with the relevant general safety and performance requirements […]