No, legacy devices – i.e.devices complying with the old European Directives (MDD 93/42/EEC and AIMDD 90/385/EEC) – are not subject to the UDI requirement, even if they continue to be placed on the market after the entry into force of the new MDR and IVDR Regulations, provided they are covered by a still valid certificate issued according to the Directives.

However, legacy devices must be registered in EUDAMED.