We provide weekly 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 weekly 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. 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...
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...
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 -...