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Under EU MDR, a Manufacturer is required to draw up a summary of safety and clinical performance (SSCP) for implantable device 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).

 

Main Revision includes 

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 information3.

 

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.

 

This document lists down the following guidance:

1. The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN
2. The intended purpose of the device and any indications, contraindications and target populations
3. A description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device
4. Information on any residual risks and any undesirable effects, warnings and precautions
5. The summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up
6. Possible diagnostic or therapeutic alternatives
7. Suggested profile and training for users
8. Reference to any harmonised standards and CS applied
9. Revision history

Click here to read the complete Publication!

 

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