We provide consistent 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 consistent 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. QMSR Tool - 5 days left at intro price (-20%) With the link below, you get direct access to the tool. Offer ends by September 30, 2025. Link to Tool Do you need more detailed information? Check our QMSR Tool guide here: Link to Guide Regulation and Guidelines: (New): COMMISSION DELEGATED REGULATION (EU) 2025/1920 of 12 June 2025 amending Regulation (EU) 2017/745 of the European...
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