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...
about 1 month ago • 1 min read
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...
about 2 months ago • 1 min read
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...
2 months ago • 1 min read
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...
3 months ago • 1 min read
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...
6 months ago • 1 min read
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...
8 months ago • 1 min read
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...
8 months ago • 1 min read
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: New: Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices This regulation establishes procedures for joint scientific consultations on medical devices and in vitro...
9 months ago • 2 min read
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: EU MDR 2017/745 - Consolidated version The European Commission has published a new consolidated version where they have integrated the reference to "Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024". The consolidated version can be downloaded with the link below. Link to document Regulation (EU) 2025/117 -...
9 months ago • 1 min read