New published MDCG 2024-5


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

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

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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Dear Reader Please find below the latest news related to medical devices in Europe. IMDRF: In Vitro Diagnostic Medical Device Regulatory Submission Table of Contents (IVD ToC): The purpose of this document is to create a comprehensive submission structure that minimizes regional divergences and indicates where regional variation exists. This document is intended to provide guidance regarding the location of submission elements in the internationally defined structure.Link to document Update:...

Dear Reader Please find below the latest news related to medical devices in Europe. New: MDCG 2024-1-5 Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence.: It provides further clarification for vigilance reporting of Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation...

Dear Reader Please find below the latest news related to medical devices in Europe. The European Commission granting more transition time for certain IVD devices: The European Commission welcomes granting more transition time from the current directive to the new EU IVDR Regulation for certain IVD devices: High individual and public health risk devices such as HIV or hepatitis tests (class D) will have a transition period until December 2027. High individual and/or moderate public health risk...