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MDCG 2021-28 Substantial modification of clinical investigation under MDR

The MDCG is providing another form regarding communication with Competent Authorities about clinical trials. In the absence of the European database on medical devices (EUDAMED),  guidance 2021-28 ‘Substantial modification of clinical investigation under MDR’ and its embedded submission form can be used for to notify the Member State(s) in which a clinical investigation is being or is to be conducted of planned modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation. Such notifications must be submitted by the Sponsor within one week.

The actual form is in an embedded link in the pdf (a direct link is provided below). Data fields correspond to the EUDAMED interface. It is foreseen that the template will be withdrawn once the EUDAMED module for clinical investigations is fully functional.

Other related guidance and forms provided earlier by the MDCG are 2021-8 ‘Clinical investigation application/notification documents’ (May 2021) and MDCG 2021-20 ‘Instructions for generating CIV-ID for MDR Clinical Investigations’ (July 2021)

Link to overview page of all MDCG endorsed documents and other guidance:

https://ec.europa.eu/health/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en  

Link to MDCG 2021-28:

https://ec.europa.eu/health/system/files/2022-01/mdcg_2021-28_en.pdf 

Link to embedded Notification Form:

https://ec.europa.eu/health/system/files/2021-12/mdcg_2021-28_annex_1_en.pdf 

Veröffentlicht am:: Februar 09, 2022
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