Safety and Performance (SSP) of Class C and D IVDs

The Regulation (EU) 2017/745 on medical devices 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.

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 cards or in any other mandatory documents
 

Summary of Safety and Performance
1. For class C and D devices, other than devices for performance studies, the manufacturer shall draw up a summary of safety and performance. The summary of safety and 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 performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment 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 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, contra-indications 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) reference to any harmonised standards and CS applied;
(e) the summary of the performance evaluation as referred to in Annex XIII, and relevant information on the PMPF;
(f) the metrological traceability of assigned values;
(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 performance. Those implementing acts shall be adopted.
 
General Requirements and Recommendations for the SSCP
The information in the SSCP should be sourced entirely from the technical documentation (TD) of the device. Examples of such documents are design verification/validation reports, the risk management report/file, the clinical evaluation report, and post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans and reports. The IFU includes information extracted from the same sources as the SSCP, but may itself be used as a source for the SSCP if appropriate. The SSCP shall be kept updated in Eudamed. When the PMCF evaluation report and the periodic safety update report (PSUR) are updated at least annually, the SSCP shall be reviewed and updated20 if needed to ensure that any clinical and/or safety information in the SSCP remains correct and complete. When updating the
SSCP, all sections of the document shall be updated if needed so that they are in alignment with the most current version of the relevant parts of the TD of the device. This guide outlines the minimum content of the SSCP. The manufacturer may add further information from the TD of the device to enhance the comprehension of the mandatory information providing:
• it does not affect the readability of the SSCP and
• it excludes any element of a promotional nature.

Performance Evaluation and Clinical Evidence
1. Confirmation of conformity with relevant general safety and performance requirements, in
particular those concerning the performance characteristics, under the normal conditions of the intended use of the device, and the evaluation of the interference(s) and cross-reaction(s) and
of the acceptability of the benefit-risk ratio, shall be based on scientific validity, analytical and clinical performance data providing sufficient clinical evidence, including where applicable
relevant data. The manufacturer shall specify and justify the level of the clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose. To that end, manufacturers shall plan, conduct and document a performance evaluation.
2. The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan.
3. A performance evaluation shall follow a defined and methodologically sound procedure for the demonstration of the following:
(a) scientific validity;
(b) analytical performance;
(c) clinical performance.
The data and conclusions drawn from the assessment of those elements shall constitute the clinical evidence for the device. The clinical evidence shall be such as to scientifically demonstrate, by reference to the state of the art in medicine, that the intended clinical benefit(s) will be achieved and that the device is safe. The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance, that the relevant general safety and performance requirements set out in Annex I, are fulfilled, under normal conditions of use.
4. Clinical performance studies shall be carried out unless it is duly justified to rely on other sources of clinical performance data.
5. The scientific validity data, the analytical performance data and the clinical performance data, their assessment and the clinical evidence derived therefrom, shall be documented in the performance evaluation report. The performance evaluation report shall be part of the technical documentation,
referred to in Annex II, relating to the device concerned.
6. The performance evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from implementation of the manufacturer’s PMPF plan and the post-market surveillance plan. The performance evaluation report for class C and D devices shall be updated when necessary, but at least annually, with the data. The summary of safety and performance shall be updated as soon as possible, where necessary.
7. Where necessary to ensure the uniform application of Annex XIII, the Commission may, having due regard to technical and scientific progress, adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure.