We provide weekly 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
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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: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:
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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: MDCG 2019-6 Rev.5 - Questions and answers: Requirements relating to notified bodies This 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...
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 -...