Europe – MDCG 2019-9 : Summary of safety and clinical performance – A guide for manufacturers and notified bodies

Introduction

The Regulation (EU) 2017/745 on medical devices (1) requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or investigational devices. The SSCP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed)1.

The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device. The SSCP will be an important source of information for intended users – both healthcare professionals and if relevant for patients. It is one of several means intended to fulfil the objectives of the Medical Device Regulation (MDR) to enhance transparency and provide adequate access to information.

The SSCP is not intended to:

• give general advice on the diagnosis or treatment of particular medical conditions, nor
• replace the instructions for use (IFU) as the main document that will be provided to ensure the safe use of a particular device, nor
• replace the mandatory information on implant cards4 or in any other mandatory documents.

The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP. The word “shall” is used when there is a corresponding “shall” in the MDR, otherwise “should” or “recommended” etc. is used indicating the interpretation of the MDR.