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Regulation (EU) 2017/746 of the European Parliament and of the CouncilDangos y teitl llawn
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)
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Article 29Summary 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 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.
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 in accordance with the advisory procedure referred to in Article 107(2).
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