Substantial Modification of Clinical Investigation under Medical Device Regulation

On 9 December 2021 the European Commission published the medical device coordination group (MDCG) document 2021-28.

The sponsor of a clinical investigation is required to submit an application/notification to the Member State(s) in which a clinical investigation is to be conducted, accompanied by the documentation referred to in Chapter II of Annex XV of Regulation (EU) 2017/745 (MDR). The application/notification is required to be submitted by means of the electronic system referred to in Article 73 of the MDR.

Additionally, 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 the same electronic system.

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