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 pursuant to Article 48 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 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, contra-indications 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;
reference to any harmonised standards and CS applied;
the summary of the performance evaluation as referred to in Annex XIII, and relevant information on the PMPF;
the metrological traceability of assigned values;
suggested profile and training for users;
information on any residual risks and any undesirable effects, warnings and precautions.
This tool is provided for convenience only and has no legal effect. Only the texts published in the Official Journal of the European Union are authentic. Source: EUR-Lex, CELEX 02017R0746-20250110, © European Union. Reuse is authorised provided the source is acknowledged.