IVDR transition and EUDAMED: two timelines to track
Conditional transition periods and database obligations answer different compliance questions.
The transition dates
Regulation (EU) 2024/1860 extends eligible legacy-device transitions to 31 December 2027 for IVDD-certified and class D devices; 31 December 2028 for class C; and 31 December 2029 for class B and class A sterile. Eligibility is conditional, including continued IVDD compliance, no significant design or intended-purpose change, acceptable risk, an IVDR quality system by 26 May 2025, and timely notified-body application and agreement.
A separate database milestone
The European Commission states that four EUDAMED modules became mandatory on 28 May 2026: actor registration, UDI/device registration, notified bodies/certificates, and market surveillance. Responsibilities differ by actor; the market-surveillance module concerns authorities.
Turn dates into responsibilities
A useful planning exercise is to maintain separate records for transition eligibility and database obligations. Assign an owner, supporting evidence and a review date to each relevant requirement. A future transition end date should not be interpreted as permission to postpone every earlier obligation.
Sources & further reading
Read the original company post on LinkedInRegulation (EU) 2024/1860European Commission — mandatory EUDAMED modulesAdapted from a public company post, with sources checked on 8 October 2026. Original post dates are preserved; the website summary is not attributed to an individual employee.
