1) New Regulatory Obligations
- Supply Interruption Notifications
Starting 10 January 2025, manufacturers must notify competent authorities and health institutions in advance of any disruption or discontinuation of medical device supply. This applies to all device types, including legacy models, under Regulation (EU) 2024/1860. - UDI Requirements for Class I Devices
By 26 May 2025, Class I devices must include UDI carriers on labels as per MDR Article 123(3)(f).
2) EUDAMED Roll-Out
- On 27 November 2025, the EU confirmed that four EUDAMED modules (Actor registration, UDI/Device registration, Notified Bodies & Certificates, Market Surveillance) are functional.
- These modules become mandatory from 28 May 2026, starting a six-month transition period. Manufacturers should prepare now for registration and vigilance reporting.
3) Harmonized Standards Update
- Commission Implementing Decision (EU) 2025/2078 introduced new harmonized standards for surgical drapes, gowns, clean air suits, medical face masks, and sterilizers. Manufacturers must update technical documentation and declarations of conformity to reference these 2025 editions.
4) Extended Transition Periods
Under Regulation (EU) 2023/607, legacy devices can remain on the market until 2027 or 2028, depending on risk class, provided conditions are met (valid certificates, QMS implementation, NB application).
5) Upcoming Legislative Changes
- The European Commission is conducting a targeted evaluation of MDR and IVDR throughout 2025, with proposals for revisions expected by early 2026. These aim to simplify processes and address implementation challenges.