In January 2025, Health Canada published a new guide on the use of recognized standards to demonstrate compliance with the requirements of the Medical Devices Regulations. The document guides manufacturers in preparing submissions, updates and lifecycle management of applicable standards.

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.