IMDRF + MDCG 2021-5 Rev.1 "Guidance on standardisation"
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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. Update: MDCG 2021-5 Rev. 1 - Guidance on standardisation for medical devices:This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities. The detailed changes of Rev. 1 can be found on page 2. Join our AI Group on LinkedIn - AI Integration for Businesses (Focus: Medical Industry)!The goal of this new group is to create a collaborative space where professionals, innovators, and enthusiasts in the medical device space can share insights, best practices, relevant regulations, and advancements related to AI applications. We wish you a nice Weekend! Your Regulatory Globe Team Follow us on LinkedIn or use our Newsletter App: Apple / Android Regulatory Globe Tools and Services: Link |
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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...
EU Commission granting more transition time for certain IVD devices / Several IMDRF document updates
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...
Dear Reader 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,...