Guidance MDCG 2024-3 on content of the Clinical Investigation Plan for clinical investigations of medical devices

The Medical Device Coordination Group (MDCG) has published the MDCG 2024-3 guide regarding the content of the clinical investigation plan for clinical investigations for devices (medical devices, accessories, and products listed in Annex XVI of Regulation (EU) 2017/745 (MDR)).

It has been following contribution from national competent authorities, industry and relevant stakeholders. Therefore, it should be recognized as best practice for the development of the Clinical Investigation Plan (CIP).

It is intended to support sponsors developing their CIP by describing what type of information is expected in the respective CIP sections, to pre-empt questions from the competent authorities during the assessment of the clinical investigation application. Moreover, a CIP with the appropriate content will be instrumental in the conduct of the clinical investigation.

The content of the CIP should be adapted based on the type of clinical investigation and the type and development stage of the investigational medical device. The legal requirements in Section 3 of Chapter II of Annex XV of MDR must be addressed or indicated as “not applicable” with justification.

In combined studies of medical devices and pharmaceutical products, there is an obvious need to accommodate the legal requirements from several regulations, and thus 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.

DOWNLOAD THE GUIDANCE MDCG 2024-3