We provide weekly updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
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Regulation and Guidelines:Mandatory: Article 10a of the EU MDR: Supply Interruption or Discontinuation NotificationFrom today (January 10, 2025) Manufacturers must inform relevant parties about anticipated interruptions or discontinuations in device supply that could result in serious harm or risk of serious harm to patients or public health. Updated: MDCG 2023-3 Rev. 2This document aims to clarify important terms and concepts outlined in Section 2 of Chapter VII of the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. It provides guidance on the implementation of vigilance requirements under these regulations, focusing on definitions, reporting criteria, and processes related to incidents and serious incidents for medical devices and in vitro diagnostic medical devices. Updated: MDCG 2024-7 Rev.1 - Preliminary assessment review template - MDR (Regulation (EU) 2017/745)This document serves as a template for Designating Authorities (DAs) to review applications from Conformity Assessment Bodies (CABs) seeking designation as Notified Bodies under the Medical Device Regulation (EU) 2017/745. It covers various aspects of the CAB's organization, quality management, resources, and processes to ensure compliance with regulatory requirements. What else could be interesting: We wish you a great weekend! Your Regulatory Globe Team Homepage: www.regulatoryglobe.com Regulatory Assistant: www.regulationagent.com Follow us on: |
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. New Tool - QSR to QMSR Gap-Assessment Tool: We are happy to announce the release of our new tool designed to help you seamlessly align with the new Quality Management System Regulation (QMSR) and ISO 13485:2016. This is the first generation of our online-based gap assessment tool. Its web-based nature allows us to keep it continuously up to date and paves the way for future...
Dear Reader Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe. Regulation and Guidelines: Implementation Decision (EU) 2025/679 of 8 April 2025 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of medical devices This implementing decision amends the previous Implementing Decision (EU) 2021/1195 by adding new harmonized standards for the sterilization of medical devices. It specifically...
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...