EUDAMED - All You Need to Know
Dear Reader
EUDAMED - All You Need to Know
We are pleased to share our latest blog post, "EUDAMED - All You Need to Know". As professionals in the medical device industry, it's crucial to stay informed about the European Database on Medical Devices. Our blog offers a clear and concise overview of EUDAMED, covering its functionalities and compliance requirements. This resource is designed to support you in navigating the complexities of EUDAMED efficiently.
Revision Update on MDCG 2022-11
The position paper "Notice to manufacturers and notified bodies to ensure timely compliance with EU MDR and EU IVDR requirements" has newly added the section "Call to notified bodies to streamline the certification process" and revised section "Call to manufacturers...".
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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...
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...