We provide consistent updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
AI-Enabled Software Devices / MDCG 2024-14 Rev.1 / Swissdamed UDI Handbook
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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 lensesThis document aims to provide guidance on the implementation of Master UDI-DI rules for contact lenses, specifically regarding its structure, assignment, labelling, and registration in Eudamed. It is intended to be read in conjunction with Regulation (EU) 2017/745 on medical devices (MDR), Commission Delegated Regulation (EU) 2023/2197 as amended by Commission Delegated Regulation (EU) 2025/788, and other MDCG Guidance documents on UDI. Main changes:
One of the main benefits of our new QSR to QMSR Gap-Assessment Tool:For each QSR requirement, we explain the similarities, differences, and key aspects compared to the corresponding ISO 13485 and/or QMSR requirements. This makes it much easier to understand and identify potential gaps.
The tool is currently available at a special 20% discount until September 30, 2025. (Prices will increase in October.) 👉 Here you can also find a video about the tool and how it works. 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. 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. 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...