EUDAMED Device RegistrationEUDAMED Device RegistrationEUDAMED Device RegistrationEUDAMED Device Registration
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Class III Implantable CMD Compliance Date
April 14, 2023
New UK Regulation Implementation Date
May 1, 2023

EUDAMED Device Registration

April 14, 2023

Use of EUDAMED is expected to be published in the Official Journal of the EU (OJEU) in Q2 2027. Afterward, a 24-month transition period will apply for the UDI/Device registration module, making it mandatory in Q2 2029.

 

After the 24-month transition period ends, all CE Marked medical devices and IVDs, including legacy devices, must be registered in EUDAMED.

 

The exact compliance date will depend on the day EUDAMED is published in the OJEU.

 

More information can be found: HERE

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