Legacy devices: no need to update the label with a UDI-DI
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
If you are still placing legacy medical devices on the EU market, here’s a simple but important reminder: you do not need to update your labels to include a UDI-DI.
What are legacy devices?
Legacy devices are medical devices certified under the previous EU Directives — either the Medical Devices Directive (MDD 93/42/EEC) or the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC). These devices are still allowed on the market during the transitional period, provided they meet specific conditions set by the MDR.
UDI-DI labelling: what the MDR requires
The Unique Device Identification – Device Identifier (UDI-DI) is mandatory only for MDR-compliant devices. This means that manufacturers with legacy devices are not required to add the UDI-DI to the label or packaging.
In practical terms: if your device has not been re-certified under the MDR, your current labelling remains valid. No UDI-related updates are needed.
Why this matters
Many manufacturers are uncertain about UDI obligations during the MDR transition. Knowing that legacy devices are exempt from UDI-DI labelling helps you avoid unnecessary changes, save time, and maintain compliance without stress.
Need support?
If you work with legacy devices and want to make sure your documentation and labelling strategy are aligned with EU rules, our team can help.
Contact us today for expert regulatory guidance tailored to your products.
