In line with the aim of increasing transparency and providing adequate access to information of the Medical Device Regulation (MDR) 2017/745, article 32[1] of the regulation requires the manufacturer to prepare a Summary of Safety and Clinical Performance (SSCP) for class III and implantable devices.
To establish an accurate understanding of the risks and benefits of the medical device under evaluation, SSCP will include:
- All information regarding the safety and clinical performance of the device, and
- Summary of updated clinical data.
For some devices (such as those for which implant cards will be given to patients), SSCP will be created having two different parts dedicated to health care professionals and patients.
SSCP document to be validated by the Notified Body will be published and made public through EUDAMED.
Information in the Summary of Safety and Clinical Performance (SSCP) should be taken from the technical documentation of the medical device under evaluation, such as
- Design Verification Reports,
- Risk Management Report/File,
- Clinical Evaluation Report,
- Post-Market Surveillance (PMS), and
- Post-Market Clinical Follow-up (PMCF) Plans and Reports
IFU of the devices includes information from the same sources of SSCP; however, when applicable, IFU can also be used as a source for SSCP.
The Summary of Safety and Clinical Performance (SSCP) should be kept up-to-date in EUDAMED. When the PMCF evaluation report and the Periodic Safety Update Report (PSUR) are updated at least annually the Summary of Safety and Clinical Performance(SSCP) should also be reviewed and updated, if necessary, to ensure that the clinical and/or safety information is accurate and complete..
The guidance document for the presentation, content and validation of the Summary of Safety and Clinical Performance (SSCP) document is “MDCG 2019 – 9 Summary of safety and clinical performance: A guide for manufacturers and notified bodies”.
You can contact us for support to prepare a Summary of Safety and Clinical Performance (SSCP).
[1]Article 32 Summary of safety and clinical performance
1. 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 summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed.
The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available.
2. The summary of safety and clinical performance shall include at least the following aspects:
- (a) the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
- (b) the intended purpose of the device and any indications, contraindications and target populations;
- (c) 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;
- (d) possible diagnostic or therapeutic alternatives;
- (e) reference to any harmonised standards and CS applied;
- (f) the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up;
- (g) suggested profile and training for users;
- (h) information on any residual risks and any undesirable effects, warnings and precautions.
3. The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114 (2).
