Updates available from European Commission

Among recent updates available from the European Commission are the following:

• Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Version 5 dated April 2026
• MDCG 2021-24 Rev.1, Guidance on classification of medical devices
• Manufacturer Incident Report MIR PDF 7.3.1 (update 23 April 2026)
• MDCG 2026-1, Summary of EMDN 2025 Submissions and outcome of annual revision
• MDCG 2026-2, 2025-2026 Annual Revision Change Log
• MDCG 2026-3, 2026 EMDN Version History

The Commission has also adopted a delegated regulation expanding the list of class IIb implantable medical devices considered well-established technologies (WET), allowing notified bodies to assess technical documentation on a sampling basis rather than for every individual device.