Summary of Safety and Clinical Performance

Dr Klinisch research provides support for creating Summary of Safety and Clinical Performance document.

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 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 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.

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 harmonised standards and CS applied

The summary of clinical evaluation, 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

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.

The SSCP is not intended to:

Relevant SSCP information for patients

The MDR indicates that patients are also intended recipients of the information in the SSCP, “if relevant”. Devices for which information will be especially relevant for patients include:

For these devices, a part of the SSCP specifically intended for patients should be provided.

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