We provide consistent updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
New QMSR Gap-Assessment Tool / New MDCG 2025-7 document
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Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. New Tool - QSR to QMSR Gap-Assessment Tool:We are happy to announce the release of our new tool designed to help you seamlessly align with the new Quality Management System Regulation (QMSR) and ISO 13485:2016. This is the first generation of our online-based gap assessment tool. Its web-based nature allows us to keep it continuously up to date and paves the way for future enhancements and integrations that will transform how regulatory requirements are managed.
What you can expect:
The tool is currently available at a special 20% discount until August 31. (Prices will increase in September.) 👉 Here you can also find a video about the tool and how it works. Regulation and Guidelines:MDCG 2025-7: Timelines of the implementation of 'Master UDI-DI' to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectaclesThis MDCG Position Paper aims to clarify the timelines for implementing the Master UDI-DI for highly individualized devices, specifically contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. It outlines the obligations for labeling the Master UDI-DI and using the UDI/Device registration module of Eudamed, as well as the interrelation between these requirements. COMMISSION IMPLEMENTING DECISION (EU) 2025/1324 of 7 July 2025 amending Implementing Decision (EU) 2019/1396 as regards certain administrative aspects related to expert panels and as regards the designation of an additional expert panel in the field of medical devicesThis Implementing Decision amends Implementing Decision (EU) 2019/1396 to address certain administrative aspects related to expert panels in the field of medical devices. It also designates an additional expert panel for medical devices and in vitro diagnostics intended for small patient populations, such as patients with rare diseases or children. What else could be interesting:We wish you a great and successful day! Your Regulatory Globe Team 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. 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...