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MedTech Europe calls member states to keep EUDAMED voluntary until it is mandatory to use

Posted on 02.03.2023

MedTech Europe published a position paper that calls on all Member States to maintain current national processes provided that EUDAMED is not yet fully operational. To offer a consistent and level playing field for all manufacturers during this period, EUDAMED should be a voluntary alternative of complying with national registration requirements.

As there are benefits to using one central database, 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.

For further information, please contact Katalin Mate, Manager MDR & IVDR.