New Harmonised Standards related to EU MDR and EU IVDR
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Dear Reader Please find below the latest news related to medical devices in Europe. New Harmonised Standards related to EU MDR 2017/745This document describes the Commission Implementing Decision (EU) 2024/815, which amends Implementing Decision (EU) 2021/1182. It specifically pertains to harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices, and processing of health care products. The decision outlines the request made to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) for the revision of existing harmonised standards on medical devices and the drafting of new harmonised standards in support of Regulation (EU) 2017/745 New Harmonised Standards related to EU IVDR 2017/746This document describes the Commission Implementing Decision (EU) 2024/817, which amends Implementing Decision (EU) 2021/1195. The amendment pertains to the harmonised standards for the sterilisation of health care products and packaging for terminally sterilised medical devices. It specifically focuses on the addition of references to harmonised standards and amendments related to sterilization and packaging for medical devices. Regulatory Affairs Assistant - Elly:We are working intensively on our new Regulatory Affairs Assistant solution that changes the way how you interact with regulations and will help accelerate your regulatory activities. Sign up now to join the waiting list and be among the first to get access to Elly. Learn more and sign up here. We wish you a great 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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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,...
Dear Reader Happy Monday! Please find below the latest news related to medical devices in Europe. New: MDCG 2024-4 The MDCG 2024-4 describes the safety reporting requirements for performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. It provides guidelines for reporting forms, completion guidelines, definitions of terms, reporting methods, and reportable events. The document also outlines the roles and responsibilities of various entities involved in the...