MDCG 2019-9 guidance on the Summary of Safety and Clinical Performance updated

The Medical Device Coordination Group (MDCG) on 24 March 2022 released the updated guidelines on the Summary of Safety and Clinical Performance updated (SSCP) for Manufacturers and Notified Bodies. It is the Revision 1 of the MDCG 2019-9 paper “Summary of Safety and Clinical Performance: a guide for manufacturers and notified bodies” applicable to implantable or class III devices.

MDCG 2019-9 guidance on the Summary of Safety and Clinical Performance updated
MDCG 2019-9 guidance on the Summary of Safety and Clinical Performance updated

Why is it important to elaborate a Summary of Safety and Clinical Performance updated (SSCP)?

The SSCP’s goal is to provide the public and interested parties, such as healthcare professionals and patients, with an up-to-date summary of clinical data and other relevant information on the safety and clinical performance of the device.

Therefore, SSCP is an important source of information for users because it allows to improve transparency and to provide adequate access to information.

What aspect of MDR was clarified by the guidance?

As you know, as pointed put by the MDR (EU) 2017/745 Regulation, the Manufacturer must elaborate and provide a Summary of Safety and Clinical Performance updated (SSCP) for implantable and class III Medical Devices. The SSCP paper must be validated by a Notified Body (NB) and made available for the public through the European Medical Devices database EUDAMED.

With Rev.1 from MDCG 2019-9 guidance, in just one section (3.1) it is clarified how to associate SSCP with the Basic UDI-DI in EUDAMED.

In particular, the guideline states that the Summary must be associated with one or more Basic UDI-DIs in the case of a single device, whereas if the product is a system composed of several devices – whereby not only the system, but also each component has its own Basic UDI-DI – it is the Basic UDI-DI for the system that must be associated with SSCP in EUDAMED.

Are you a Manufacturer of implantable or class III medical devices and need support in drafting SSCP?

Thema experts can provide you with specific support, until you obtain the EU Certificate for your Medical Devices.

Contact our Customer Service for more information.