We provide consistent 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 consistent 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. QMSR Tool - 5 days left at intro price (-20%) With the link below, you get direct access to the tool. Offer ends by September 30, 2025. Link to Tool Do you need more detailed information? Check our QMSR Tool guide here: Link to Guide Regulation and Guidelines: (New): COMMISSION DELEGATED REGULATION (EU) 2025/1920 of 12 June 2025 amending Regulation (EU) 2017/745 of the European...
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Are you curious how our new QMSR Gap-Assessment Tool works? No problem. We have created a full guide. Check the link below to get more detailed information. Link to Guide Regulation and Guidelines: Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices...
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Our new QMSR Gap-Assessment Tool is currently available at a special 20% discount until September 30, 2025. (Prices will increase in October.) Test Tool Regulation and Guidelines: Opinion of the European Committee of the Regions Cybersecurity of hospitals and healthcare providers This document provides policy recommendations on cybersecurity for hospitals and healthcare...