What is SSCP?
The SSCP (Summary of Safety and Clinical Performance) 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 for a device should include in particular the place of the device in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when compared to the diagnostic or therapeutic alternatives and the specific conditions under which that device and its alternatives can be considered.
For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.
The SSCP is not intended to:
- Give general advice on the diagnosis or treatment of particular medical conditions
- Replace the instructions for use (IFU) as the main document that will be provided to ensure the safe use of a particular device
- Replace the mandatory information on implant cards or in any other mandatory documents
SSCP shall be reviewed and updated (if needed) along with annual updates of Post- Market Clinical Follow-up (PMCF) and Periodic Safety Update Report (PSUR). The SSCP shall be validated by a Notified Body (NB) and made available to the public via the European database on medical devices (Eudamed).
The associated objectives of the SSCP are:
- Greater transparency of information to healthcare providers, to give them confidence that they are presenting the best treatment options and making the right decisions for their patients
- Empowerment to patients, to give them the information they need to be able to discuss available treatment options with their clinician and guide their decision-making
According to Article 32 of EU MDR 2017/745; the summary of safety and clinical performance shall include at least the following aspects:
- The identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
- The intended purpose of the device and any indications, contraindications and target populations;
- 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;
- Possible diagnostic or therapeutic alternatives;
- Reference to any harmonized standards and CS applied;
- The summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up;
- Suggested profile and training for users;
- Information on any residual risks and any undesirable effects, warnings and precautions.
Basic Overview of the contents to be included in SSCP:
- Device identification and general information
- Device trade name(s)
- Manufacturer’s name and address
- Manufacturer’s single registration number (SRN)
- Basic UDI-DI
- Medical device nomenclature description / text
- Class of device
- Year when the first certificate (CE) was issued covering the device
- Authorized representative if applicable; name and the SRN
- NB’s name (the NB that will validate the SSCP) and the NB’s single identification number
- Intended use of the device
- Intended purpose
- Indication(s) and target population(s)
- Contraindications and/or limitations
- Device description
- Description of the device
- A reference to previous generation(s) or variants if such exist, and a description of the differences
- Description of any accessories which are intended to be used in combination with device
- Description of any other devices and products which are intended to be used in combination with the device
- Risks and warnings
- Residual risks and undesirable effects
- Warnings and precautions
- Other relevant aspects of safety, including a summary of any field safety corrective action (FSCA including FSN) if applicable
- Summary of clinical evaluation and post-market clinical follow-up (PMCF)
- Summary of clinical data related to equivalent device, if applicable
- Summary of clinical data from conducted investigations of the device before the CE-marking, if applicable
- Summary of clinical data from other sources, if applicable
- An overall summary of the clinical performance and safety
- Ongoing or planned post-market clinical follow-up
- Possible diagnostic or therapeutic alternatives
- Suggested profile and training for users
- Reference to any harmonized standards and CS applied
- Revision history
