Document paper

A call to keep EUDAMED voluntary until it is mandatory to use

Until EUDAMED is fully operational, MedTech Europe urges all Member States to maintain current national processes. EUDAMED should be a voluntary alternative of complying with national registration requirements rather than the only way of complying with them.

We encourage Member States to allow the use of EUDAMED as a voluntary means of complying with registration requirements to avoid double registration. However, the exclusive and mandatory (or strongly encouraged) use of EUDAMED should not be the only way to comply with national registration requirements.

Posted on 07.02.2023