Commission Decision (EU) 2025/2371 triggered the transition period leading to the 27 November 2026 deadline for the registration of legacy devices in EUDAMED.

With the deadline approaching, manufacturers should ensure that the required device information is complete, accurate, and ready for registration. This involves more than entering data into EUDAMED: product and UDI information must be correctly aligned with actor registration (SRN), certification data, and the relevant EUDAMED modules.

Manufacturers should use the remaining transition period to identify data gaps, validate existing information, and clarify the responsibilities of manufacturers, Authorized Representatives, and Notified Bodies.

Need support preparing for the EUDAMED deadline? Get in touch with us to ensure your registrations are completed correctly and on time.