MDCG 2021-28: Model notification form for substantial modification of clinical investigation under Medical Device Regulation (EU) 2017/745

The sponsor of a clinical investigation is required to notify the Member States in which a clinical investigation is or is to be conducted if it intends to introduce changes to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of subjects or on the robustness or reliability of the clinical data generated by the investigation, within one week, using the same electronic system.

In the absence of the European database on medical devices (EUDAMED), a series of application and notification documents have been published to facilitate the implementation of clinical investigation procedures under Regulation (EU) 2017/745 (see: MDCG 2021-8 and MDCG 2021-20).

To supplement these documents, the Medical Device Coordination Group (MDCG) has just published a template form to be completed in order to notify substantial changes to the clinical investigation under Regulation (EU) 2017/745.

As much as possible, this template includes the same fields as those planned in EUDAMED (in development). It is expected that this template will be removed when the EUDAMED module for clinical investigations is fully functional.

Note: It is important to check, for each Member State in which the clinical investigation takes place or is to be conducted, whether country-specific requirements apply.

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