We provide consistent updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
New Regulation (EU) 2025/327 - European Health Data Space (EHDS) + Effortless Regulatory Tracking
|
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 framework for the development, marketing, and use of electronic health record systems across the EU. What else could be interesting: Effortless Regulatory Tracking with Elly:Keeping up to date with the latest regulations is a key element in the field of regulation. With Elly, you have access to the latest updates from the following countries: USA, EU (all members), Canada, Brazil, India, Australia, Japan, UK, China, Saudi Arabia, Switzerland, and Singapore. Here’s how it works:
We wish you a great weekend! 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...