On March 12^th, 2024, the Medical Device Coordination Group (MDCG) released guidance on the content of the Clinical Investigation Plan for clinical investigations of medical devices according to article 70(1) of Regulation (EU) 2017/745 or the Medical Device Regulation to the Member State(s) in which the clinical investigation is to be conducted, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR.  (MDCG 2024-03).

MDCG 2024-03 – Guidance on the content of the Clinical Investigation Plan for clinical investigations of medical devices

This guidance document, which is developed by contribution from national competent authorities, industry and relevant stakeholders can be recognized as best practice and should support the sponsors of those clinical investigation plans (CIP) as it describes in great detail what type of information is needed in the respective CIP sections, to pre-empt questions from the competent authorities during the assessment of the clinical investigation application. The CIPs should be adapted based on the type of clinical investigation and type of development stage of the investigational medical device. Last, for combined studies of medical devices and pharmaceutical products, legal requirements from several regulations should be addressed for which the structure and content of the CIP may need to be adapted. However, sponsors need to be aware that the elements required by MDR need to be present in a combined CIP/study protocol, and this guidance is intended to be useful also in those situations.