Clinical investigations of medical devices that are conducted as part of the clinical evaluation for conformity assessment purposes and where the investigational device either may not yet bear a CE mark or its use in the clinical investigation is outside its intended purpose require approval by the competent federal higher authority.

According to Article 74(1) MDR, a Post-Market Clinical Follow-up investigation (PMCF investigation) is a clinical investigation conducted after the medical device has been placed on the market for the purpose of further assessment of that device.

Other clinical investigations "are governed by the legal basis laid down in Article 82 of Regulation (EU) 2017/745 (MDR), which is further elaborated at national level by the Medical Device Law Implementation Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG)".

Substantial modifications to a clinical investigation must be notified to the competent ethics committee and the competent federal higher authority in accordance with Article 75 of the European Regulation 2017/745 (MDR), and Section 54 of the Medical Devices Law Implementation Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG), respectively, prior to implementation.

If the sponsor has temporarily halted a clinical investigation or has terminated a clinical investigation early, it shall inform the Member State.