We provide weekly updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
AI in Medical Devices (Checklist)/ New MDCG document
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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 2024-14 Guidance on the implementation of Master UDI-DI solution for contact lensesThis document provides crucial guidance on implementing the Master UDI-DI (Unique Device Identification - Device Identifier) solution for contact lenses under the EU Medical Device Regulation (MDR) 2017/745. Medical devices AI questionnaire jointly published by IG-NB & Team NBThis questionnaire was prepared in accordance with MDGG 2022-14 requests. It is to be understood in the context of MDR and IVDR Regulations as well as MDCG guidance (MDSW). Specific requirements of the AI Regulation 2024/1689 have not been considered and will be part of a comprehensive revision which is to follow. However, it should be acknowledged, that there is a considerable overlap of requirements stated in the AI Regulation and the existing regulatory and standards framework for software and AI. For a clearer overview of the Medical Devices AI questionnaire, we at Regulatory Globe have created a helpful checklist. Feel free to download it here: AI for Medical Devices Checklist_Rev. a.xlsx What else could be interesting: Webinar on December 5, 2024 (4 pm - 5 pm CET): Agenda:
Who Should Attend?: Regulatory and Quality Professionals in the Medical Device and In-Vitro Diagnostics Industry. Key Benefits: Learn how Elly can reduce time and regulatory complexity in your daily work. Special Highlights: Discover Elly’s supportive tools like: News Feed, Initial Document Assessment, Automated “Intended Purpose” and “Classification” support, and much more.
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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: 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...