An analysis of the EU MDCG recommendations concerning the content of a Clinical Investigation Plan and an Investigator’s Brochure
£45.00
Ensure your clinical investigations meet EU expectations – this expert guide clarifies what regulators expect in both the CIP and Investigator’s Brochure
English
Marzena Bielińska, Ilona Korczak-Cegielska and Patrycja Rak summarise the essential documents needed for a clinical investigation according to Regulation (EU) 2017/745 on medical devices, with a specific focus on the content of the Clinical Investigation Plan (CIP) and Investigator’s Brochure (IB) as elaborated by the Medical Device Coordination Group (MDCG). The MDCG 2024-3 guidance describes the content of the CIP while MDCG 2024-5 describes the contents of the IB. Both guidelines refer to ISO 14155 as the standard for the clinical investigation of medical devices for human subjects. This article identifies 19 key elements for the CIP listed as the minimum required content, which should be adapted based on the type of clinical investigation, and type and development stage of the investigational medical device. It also lists eight key elements for the IB.
Specification: 10 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the November 2024 issue of the Journal of Medical Device Regulation.
