We provide consistent updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
MDCG 2019-6 Rev.5 + Impactful updates on Elly
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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:MDCG 2019-6 Rev.5 - Questions and answers: Requirements relating to notified bodiesThis 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 various aspects of notified body requirements, including organizational structure, impartiality, personnel qualifications, and conformity assessment procedures. What else could be interesting:Regulatory Assistant - Elly: Impactful updates1. News Feed: You can now open documents directly from the news feed for easy access to PDFs. 2. Sorting by Country: You can now sort documents by country. With these updates, you now have direct access to over 4,000 relevant regulatory documents from 37 countries.
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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...