We provide weekly updates about regulations and guidelines in the European Medical Device and In-Vitro Diagnositc Industry.
New mandatory EU MIR form / Standards for sterilization / Other Standard Updates
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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:Implementation Decision (EU) 2025/679 of 8 April 2025 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of medical devicesThis implementing decision amends the previous Implementing Decision (EU) 2021/1195 by adding new harmonized standards for the sterilization of medical devices. It specifically addresses the adoption of revised standards EN 556-1:2024 and EN 556-2:2024, which are related to requirements for medical devices to be designated as "STERILE". Updated: Manufacturer Incident Report MIR Form 7.3.1The European Commission has announced that the new Manufacturer Incident Report (MIR) form version 7.3.1 will become mandatory from November 2025. This upgraded form is crucial for reporting serious incidents related to medical devices and in vitro diagnostic medical devices under EU regulations. What else could be interesting:Standard Updates:ISO 10993-23:2021/Amd 1:2025Biological evaluation of medical devices — Part 23: Tests for irritation Amendment 1: Additional in vitro reconstructed human epidermis models EN ISO 10993-5:2009/A11:2025Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity EN ISO 10993-4:2017/A1:2025Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025, Corrected version 2025-04) For further regulatory standard support, feel free to contact us or start with our Regulatory Intelligence Paper - Standard Version. We wish you a great day! 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. 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...