EUDAMED introduction postponed: New deadline until Q2 2027 / Q2 2029 | EN

The European Commission has postponed the deadlines for the implementation of the EUDAMED medical device monitoring system. Full operational readiness has been moved from Q2 2024 to Q2 2027, with a final deadline of Q2 2029 for mandatory use of all modules.
The delay is due to the overload of notified bodies and the underestimated complexity of developing the modules. The notified bodies are struggling with the implementation of the new EU Medical Device Regulation (MDR); there are currently only 40 bodies with MDR authorisation compared to 75 (MDD) in 2013. EUDAMED was originally intended to be fully functional in May 2020, but a staggered introduction was favoured due to development delays.
Consequences for manufacturers
The delay gives manufacturers more time to fulfil the requirements of the MDR. This applies to the registration of products and the submission of data for clinical trials. It reduces the pressure on manufacturers, especially SMEs, who would otherwise have found it difficult to meet the deadlines.
The transition period for the mandatory use of the first four modules has been set for Q4 2027, while the last two modules will become mandatory by Q2 2029. Although the deadlines have been extended, it is important for manufacturers to prepare in good time to avoid falling behind.
Please note that the legal framework may change. The updated information on the EUDAMED roadmap can be found at the link provided: EUDAMED roadmap. (Status: November 2023)
Overview of the postponed deadlines
Not only has the date for the overall readiness of EUDAMED been adjusted, but also the deadlines for the mandatory use of its six core modules. The new planning now looks like this:
Nach oben scrollen