What’s the latest?
With MDR date of application fast approaching, there are still some unanswered questions related to the transition process for ‘legacy devices.’
Legacy devices are medical devices and IVDs that will continue to be placed on the market with valid CE marking under the Directives (MDD, AIMDD, IVDD), after the MDR and IVDR has gone into effect.
Last week, the EU Commission (EC) addressed some of these pending questions with the publication of the help guide – Management of Legacy Devices in EUDAMED. This guide should be reviewed in combination with the April 2019 guidance released by the MDCG – Registration of legacy devices in EUDAMED (MDCG 2019-5).
The new guide provides additional details on how manufacturers of legacy devices can identify their products in EUDAMED if they have not yet obtained assignment of a basic UDI-DI and a UDI-DI. This provides important clarification to manufacturers, as legacy devices don’t require UDIs until the products fully comply with the MDR or IVDR.
Some key takeaways:
- Legacy devices are subject to the same EUDAMED registration requirements as MDR and IVDR compliant products
- All devices require a unique identification number in the system
- Legacy devices with a UDI-DI already assigned may use the assigned code for EUDAMED registration
- Legacy devices without a UDI-DI assigned will receive a EUDAMED ID code – this unique code will be used to generate a unique EUDAMED DI code to be used in the system (see below table for comparison)
- Steps are available for manufacturers to transition ‘legacy devices’ to MDR or IVDR devices in the system, when needed
Legacy Devices without
|Legacy Devices with UDI-DI/Non-Legacy Devices