We provide consistent updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
New implementing Regulation (EU) 2025/117 + several new and updated MDCG documents related to EMDN codes
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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: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 devicesThis regulation establishes procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices under Regulation (EU) 2021/2282. It outlines processes for consultation requests, briefing package preparation, expert involvement, and coordination with expert panel consultations. New: MDCG 2025-1 EMDN Ad hoc procedureThis document provides a form for the submission of proposals under the ad-hoc update procedure for the European Medical Device Nomenclature (EMDN). New: MDCG 2025-2 EMDN update submissions from 2024 public consultation and the MDCG nomenclature working groupThis document outlines the outcomes of the analysis of submissions for updates to the European Medical Device Nomenclature (EMDN). It includes accepted, partially accepted, and not accepted submissions from the 2024 public consultation and the MDCG Nomenclature working group. The document provides details on proposed changes to various medical device categories and codes within the EMDN system. New: MDCG 2025-3 EMDN Version HistoryThis document outlines the changing history of EMDN codes. Updated: MDCG 2021-12 Rev.1 FAQ on the European Medical Device Nomenclature EMDNThis document provides frequently asked questions (FAQ) about the European Medical Device Nomenclature (EMDN). Updated: MDCG 2024-2 Rev.1 Procedures for the updates of the EMDNThis document outlines the procedures for annual revisions and ad-hoc expedited updates to the European Medical Device Nomenclature (EMDN). It lays out the processes for both the annual review and the procedure for ad-hoc requests requiring an expedited review. Updated: MDCG 2021-15 Rev.1 Applying for designation as notified body under the medical devices regulation (MDR)This document is an application form and checklist for conformity assessment bodies applying to be designated as notified bodies under the EU Medical Device Regulation (MDR) 2017/745. What else could be interesting:We look forward to continuing to provide you with valuable updates and high-quality checklists free of charge. To ensure the quality of this content, we would like to integrate selected advertising partners into our newsletter. This will enable us to provide you with even more useful information and relevant offers. If you would like to be represented in the newsletter with your logo or in another form, click on the button below to find out more.
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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. 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. 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...