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Please find below the latest news related to medical devices in Europe.

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New: MDCG 2024-5 - Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices

This document describes the requirements and guidelines for the submission package for a clinical investigation of a medical device, as outlined in Chapter II of Annex XV of the Medical Device Regulation (EU MDR). It includes details such as the identification and description of the device, information on its intended purpose, risk classification, design, manufacturing, and materials used. Additionally, it outlines the need for a summary of relevant manufacturing processes, references to previous and similar generations of the device, and an overview of identified equivalent or similar devices available. The document also specifies the need for a detailed description of the clinical procedures and diagnostic tests used in the course of the clinical investigation.

​Link to document​

​Link to Appendix A​

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New Notified Body designated according to EU MDR 2017/745

The Notified Body AFNOR Certification (NB 0333) is now designated according to EU MDR 2017/745.

​Link to the scope document​

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