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;
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).
Official catalogue · non-binding
Related guidance (13)
Current English catalogue entries that refer to Article 29. Guidance is non-binding and kept separate from the regulation text.
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Gradual roll out of EUDAMEDQ&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1November 2024⌄
Gradual roll out of EUDAMEDPDF · Unverified extraction previewOfficial source
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MDCG 2022-12Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)July 2022⌄
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MDCG 2022-16Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746October 2022⌄
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MDCG 2022-9 rev.1Summary of safety and performance templateApril 2024⌄
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MDCG 2022-8Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/ECMay 2022⌄
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MDCG 2022-2Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)January 2022⌄
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MDCG 2024-8 rev.1 MDCG 2021-16/MDCG 2024-8 AnnexPreliminary assessment review (PAR) form template (IVDR) Annex to Application Form & PAR Template IVDR (List of documents)January 2025⌄
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Show all 13 guidance documentsShow only the first 8
MDCG 2024-9Preliminary re-assessment review (PRAR) form template (IVDR)May 2024⌄
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MDCG 2021-16 rev.1 MDCG 2021-16/MDCG 2024-8 AnnexApplication form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)Annex to Application Form & PAR Template IVDR (List of documents)January 2025⌄
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MDCG 2021-14Explanatory note on IVDR codesJuly 2021⌄
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MDCG 2021-19Guidance note integration of the UDI within an organisation’s quality management systemJuly 2021⌄
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MDCG 2022-14Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDsAugust 2022⌄
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