EMDN MDCG 2025 Update: New Guidance for Medical Devices

The EMDN MDCG 2025 update has been released, incorporating feedback from the 2024 Public Consultation and the MDCG Nomenclature Working Group. This annual revision aims to enhance the accuracy of medical device classification under EU regulations.

Key Updates in MDCG 2025-2

The latest guidance document, MDCG 2025-2, outlines the results of the review process, including:

• • Accepted changes based on stakeholder submissions
  • Rejected submissions and the rationale behind their exclusion
  • Additions, deletions, and partial modifications to EMDN codes and groups
  • Improved clarity to help manufacturers assign more accurate EMDN codes to their medical devices

This update aims to enhance the classification and identification of medical devices under EU regulations, ensuring greater alignment with industry needs.

Learn more: Guidance – MDCG endorsed documents and other guidance – European Commission

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