We provide weekly updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
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 |
Regulatory Newsletter (EU)
We provide weekly updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: Implementation Decision (EU) 2025/679 of 8 April 2025 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of medical devices This implementing decision amends the previous Implementing Decision (EU) 2021/1195 by adding new harmonized standards for the sterilization of medical devices. It specifically...
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: Regulation (EU) 2025/327 - European Health Data Space (EHDS) This Regulation establishes the European Health Data Space (EHDS) to improve access to and control over personal electronic health data, facilitate its use for healthcare delivery, research, innovation, policymaking, and regulatory activities. It aims to create a uniform legal and technical...
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: MDCG 2019-6 Rev.5 - Questions and answers: Requirements relating to notified bodies This document presents questions and answers on requirements relating to notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It provides clarifications and guidance on...