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:
|the identification of the device and the manufacturer, including theBasic 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 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.
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).