EC publishes guidance on Legacy Devices

Written By MDRG
Legacy Devices.png

The European Commission has released guidance on official management of Directive or legacy devices. The document details how Legacy Devices will be identified in EUDAMED and the way the different Unique Device Identifiers (UDI) for the Legacy Devices will be generated and assigned.

📢 Key Takeaways:

  • Legacy Devices = IVDD/MDD/AIMD devices that continue to be placed on the market after the date of application for MDR/IVDR

  • "Manufacturers will have the possibility to register any of their Legacy Devices in EUDAMED“

  • “Legacy Devices are subject to the MDR or IVDR registration requirements with some exceptions such as the assignment of a Basic UDI-DI and a UDI-DI.“

  • “..only one device identifier will be assigned to a Legacy Device, either a UDI-DI (where the EUDAMED DI is automatically generated) or a EUDAMED DI (where the EUDAMED ID is automatically generated)“

📚 Document: Management of Legacy Devices : MDR EUDAMED

 🔍 Link to PDF (English) : https://bit.ly/3suWEqk

MDRG
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