MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation - December 2021
Medical devices regulation
December 9, 2021, new guidance document wa released by the Medical Device Coordination Group (MDCG). This new document provide guidance with regards to substantial modifications of clinical investigation under Medical Device Regulation (MDCG 2021-28).
Under the MDR, the sponsor of a clinical investigation is required to notify the Member State(s) in which a clinical investigation is being, or is to be, conducted if it intends to introduce 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, within one week, by means of EUDAMED. However, as EUDAMED is not yet fully functional, MDCG has created a series of clinical investigation application/notification documents to support clinical investigation procedures with respect to MDR until EUDAMED is ready.
The guidance however states that it is important to check with the individual Member State in which the clinical investigation is taking place or planned to be conducted as to any specific national requirements that may apply. It also adds that this template will be withdrawn once the EUDAMED module for clinical investigations is fully functional.
Since the arrival of Regulation 2017/745, new requirements have been requested and are part of the documentation to be presented to the notified body.
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