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Please find below the latest regulatory news in Europe.

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MDCG 2024-2: Procedures for the updates of the European Medical Device Nomenclature

This document describes the procedures for the updates of the European Medical Device Nomenclature (EMDN). It outlines the annual review and update process of the EMDN based on practical use and user feedback. It also explains the roles of the Medical Device Coordination Group (MDCG) and the Nomenclature working group (NOM WG) in managing and maintaining the EMDN. Additionally, the document introduces a pilot procedure for ad-hoc updates of the EMDN that require an expedited review.

​Link to document​

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MDCG 2024-3: Guidance on content of the Clinical Investigation Plan for Clinical Investigations of Medical Devices

This document describes the requirements and guidelines for the content of a Clinical Investigation Plan (CIP) for medical devices. It includes information on the general introduction, investigational device description, clinical investigation design, subject selection, adverse events, publication policy, technical and functional features of the device, and more. Additionally, it provides guidance on the overall synopsis of the clinical investigation and the necessary information to be included in the CIP.

​Link to document​

​Clinical Investigation Plan Synopsis Template​

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