We provide consistent updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
Regulation (EU) 2025/1920 UDI for spectacle lenses - Regulation (EU) 1272/2008 substances and mixtures
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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. Do you need more detailed information? Check our QMSR Tool guide here: Regulation and Guidelines:(New): COMMISSION DELEGATED REGULATION (EU) 2025/1920 of 12 June 2025 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectaclesThis regulation amends Regulation (EU) 2017/745 on medical devices, specifically addressing the assignment of Unique Device Identifiers (UDI) for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. It introduces the concept of a "Master UDI-DI" to group similar products under the same identifier, reducing the proliferation of UDI-DIs for these highly individualized devices. (Updated): REGULATION (EC) No. 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No. 1907/2006This regulation aims to ensure a high level of protection for human health and the environment, as well as the free movement of substances, mixtures, and articles. It harmonizes the criteria for classification, labeling, and packaging of hazardous substances and mixtures in the European Union. The regulation establishes obligations for manufacturers, importers, and downstream users regarding the classification, labeling, and packaging of substances and mixtures placed on the market. What else could be interesting:We wish you a great and successful rest of the day. Your Regulatory Globe Team Our Services: Homepage: www.regulatoryglobe.com Regulatory Assistant: www.regulationagent.com Follow us on: |
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. 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...
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Promote your product or service to over 5,000 MedTech professionals. Reserve your spot in one of our next newsletters! Regulation and Guidelines: MDCG 2024-14 Rev.1: Guidance on the implementation of the Master UDI-DI solution for contact lenses This document aims to provide guidance on the implementation of Master UDI-DI rules for contact lenses, specifically regarding its...