New and updated MDCG documents + SCHEER phthalates
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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) MDR 2017/745 on medical devices. Update: MDCG 2022-13 Rev.1 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies:Reason for the update: To include guidance on the conduct of joint assessments relating to extending the scope of designations. New: MDCG 2024-10 - Clinical evaluation of orphan medical devices:This document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the EU MDR of medical devices and accessories for medical devices that qualify as ‘orphan devices’ (OD) and medical devices and accessories for medical devices that have an orphan indication, within the meaning of this guidance. This guidance is relevant to devices across all risk classes as per the classification rules defined in the EU MDR. SCHEER:SCHEER updated the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine disrupting (ED) properties. Regulatory Intelligence Paper inclusive Standard tracking? No Problem!We provide a Global Regulatory Intelligence Paper on a monthly-basis that covers the latest relevant regulations and Standard updates globally. Learn more about how this can improve your work by clicking here. We wish you a great Day! 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. 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:...
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,...