We provide consistent updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
EU MDR 2017/745 is now consolidated + New EU Regulation Streamlines Joint Scientific Consultations for Medical Devices
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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 versionThe 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. Regulation (EU) 2025/117 - 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 devicesIt outlines the processes for health technology developers to request and participate in joint scientific consultations with the Coordination Group on Health Technology Assessment. The regulation covers the submission of requests, selection and consultation of experts, and cooperation with expert panels when consultations are conducted in parallel. What else could be interesting:New Partner:We are thrilled to announce a strategic partnership between Asia Actual and Regulatory Globe GmbH. This collaboration unites Asia Actual's expertise in Asian markets with Regulatory Globe's AI-powered solutions for global medical regulations. Asia Actual specializes in helping manufacturers navigate medical device market entry and expansion in Asian markets. Their services include regulatory strategy, registration, independent license holding, importing and commercial assistance for all types of medical devices. Elly - Your personal Regulatory Affairs Assistant:Use-Case: Initial Regulatory AssessmentIt does not matter in which language, how large, or how complex the regulation is. Elly will do for you the initial assessment. How it works? See the video below:
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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...