Publication of a European Commission guide on the management of Legacy Devices in EUDAMED

The European Commission has published a guide on the management of Legacy Devices in EUDAMED.

Legacy devices are defined as Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices that are covered by a valid certificate issued under Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and that continue to be placed on the market or put into service after the date of application of Regulation (EU) 2017/745 or Regulation (EU) 2017/746.

This guidance document specifies how Legacy Devices will be identified in EUDAMED and how the different UDIs will be generated or assigned.

In accordance with MDCG Guide 2019-5 “Registration of legacy devices in EUDAMED”, in case of a serious incident or implementation of a field safety corrective action , a Legacy Device must be registered in EUDAMED prior to any submission of the follow-up or final report.

DOWNLOAD THE GUIDE “MANAGEMENT OF LEGACY DEVICES – MDR EUDAMED”

15/02/2021 |Version 1.2