Global Regulatory Pulse

MDCG ISSUES Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)

In Consulting, European Market, Regulatory by Dr. Vincent Legay

On 26 September 2019, the Medical Device Coordination Group (MDCG) released final guidance regarding Summary of Safety and Clinical Performance (SSCP), which is intended to serve as a guide for medical device manufacturers and Notified Bodies under Medical Device Regulation (MDR) 2017/745. This guidance provides clear direction on the intent, content and structure of SSCPs to optimize convergence and harmonized expectations across contributors and regulators. Please click here to access this information.

The aim of MDR 2017/745 is to not only increase safety and benefit to patients with regard to higher risk devices (Class III and implantable devices), but to also deliver data transparency, availability and proper assessment of medical products.

As a means to achieve these goals, the new requirement for manufacturers to periodically prepare SSCPs is becoming far easier to implement thanks to recent MDCG input. Ultimately, an SSCP is to be made publicly available via the European Database on Medical Devices (EUDAMED) platform, hence the requirement to consistently format and include reliable content within SSCPs—ensuring that the ultimate goals of the MDR are achieved.

Important Note: Prior to SSCP upload to EUDAMED, the document is to be reviewed and approved by the appropriate Notified Body. The document then becomes part of a device’s technical documentation, and should reflect actual data sourced from the technical documentation. This information should have limited adjustments to prevent readability issues and should also not include promotional information.

How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers.

Additionally, NAMSA provides support to market authorization holders, including implementation of MDR requirements, MDR/IVDR conformity strategies and compilation of appropriate technical documentation for submission to Notified Bodies. NAMSA’s team of medical writers and regulatory specialists can provide full support to assist—in full, or partially-with SSCP activities.

Learn more about NAMSA’s MDR resources here.

Authors:

Vincent Legay holds a PhD in Biology and an executive Masters of Business Administration (MBA), and currently serves as NAMSA’s Global Director of Product Development Strategic consulting services. He possesses over 15 years’ experience at NAMSA where he has been responsible for regulatory consulting across the entire medical device lifecycle continuum. This expertise includes management of sterilization, biocompatibility, risk management, clinical evaluation and quality management systems for clients around the globe. Currently, he oversees a team of worldwide strategic consultants and also directly supports medical device manufacturers with preclinical and clinical research approaches in an effort to meet regulatory business objectives, with a focus on MDR 2017/745.