Use of EUDAMED is expected to be published in the Official Journal of the EU in Q2 2027. Afterward, a six-month transition period will apply for the Economic Operator registration module (i.e., manufacturers, system/procedure pack producers, authorized representatives and importers).

It becomes mandatory in Q4 2027. After the six-month transition period ends, all manufacturers of CE Marked medical devices and IVDs, including legacy devices, are required to have registered in EUDAMED. Registration of Economic Operators is completed in the EUDAMED Actor module.

More information can be found: HERE