The new EUDAMED Guide to the Registration of Legacy Medical Devices provides detailed and practical instructions for manufacturers operating under the MDD or AIMDD directives. The transition to MDR requires legacy devices to be identified with EUDAMED DI and EUDAMED ID, even in the absence of a UDI-DI. This registration in the EUDAMED database is essential to ensure regulatory compliance and maintain the placement of devices on the European market.

The new EUDAMED guide for legacy devices is an essential tool for medical device manufacturers who continue to operate under the previous MDD and AIMDD directives, but want to remain compliant during the transition period to Regulation (EU) 2017/745 (MDR). The document covers the assignment of EUDAMED DI and EUDAMED ID codes, the structured registration of legacy devices, the management of certificates and linking to already registered regulated devices. With practical guidelines and examples of accepted formats, this guide contributes to strengthening the traceability, compliance and regulatory security of legacy devices still on the European market.