EUDAMED Manufacturer RegistrationEUDAMED Manufacturer RegistrationEUDAMED Manufacturer RegistrationEUDAMED Manufacturer Registration
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MDR Compliance Date: Class IIb, IIa, I devices
April 13, 2023
Class III Implantable CMD Compliance Date
April 14, 2023

EUDAMED Manufacturer Registration

April 13, 2023

EUDAMED is expected to be published in the Official Journal of the EU in Q2 2024. 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 2024. 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

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