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REGULATORY SPOTLIGHT

Insights into Annex XVI – Article 1 of 3: “Designing the Investigator’s Brochure”

June 5, 2024

This article highlights the “guidance on content of the Investigator's Brochure for clinical investigations of medical devices - MDCG 2024-5,” recently published by the Medical Device Coordination Group (MDCG). The guideline is helpful in creating the Investigator's Brochure, a key document in the submission package to NCAs, and helps avoid queries in the submission process.

This guideline is also applicable for products listed in Annex XVI of REGULATION (EU) 2017/745-Medical Device Regulation (MDR). Annex XVI lists products without an intended medical purpose which are nevertheless covered by MDR.

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