The European Commission has published guidance on the management of legacy devices in the Eudamed database, in the run up to incoming EU Medical Device and In-Vitro Diagnostics Regulations, the former of which is set to kick in later this year.
Legacy devices are products covered by certificates issued in accordance with the outgoing directives but placed on the market after the new regulations take effect. Such devices are subject to most of the incoming regulatory requirements.
The Commission guidance explains when manufacturers need to register legacy devices on Eudamed and walks through details such as how to link products covered by the outgoing and incoming regulatory frameworks.
The Commission belatedly launched the first module of Eudamed late last year. Having passed that milestone, the Commission has set out what the database, which is a key enabler of the incoming MDR and IVDR, means for manufacturers of legacy products.
Part of the document addresses general considerations for legacy devices. The Commission will make manufacturers register legacy devices on Eudamed as soon as possible if “a serious incident occurs or there is a field safety corrective action to apply.” Otherwise, manufacturers have until 18 months after the date of application of the MDR or IVDR, or longer if Eudamed is delayed, to register legacy devices that have not been made compliant with the incoming regulations.
Other sections of the guidance detail how legacy devices will be identified and linked to their MDR or IVDR compliant equivalents. Legacy devices are exempt from the requirement to get a Basic UDI-DI and UDI-DI, or unique device identifier. However, legacy devices do need a EUDAMED DI, the equivalent of the Basic UDI-DI, to ensure all devices in the database have the same standard structure and identification elements.
When a legacy device is made compliant with MDR or IVDR, a new product will be registered on the database. Eudamed supports the linking of legacy devices and their successors. MDR-IVDR compliant products that are identical to their equivalent legacy devices will share a UDI-DI. Otherwise, the manufacturer will need to provide the legacy device identifier to manually link the products.
The text published this month is version 1.1 of the guidance. No other version of the document is available on the Commission’s website but the Austrian Self Care Association has a slightly different text with a publication date in 2019. The new version hews closely to the older document, with the edits largely limited to changes to the wording and formatting. Elements of the guidance were also addressed in a 2019 document published by the EU’s Medical Device Coordination Group.
Attention will now turn to the release of other modules of the database. The Commission expects to have the second and third modules of the database available by May. The second module addresses unique device identifiers and device registration. The third module is focused on certificates and notified bodies. The Commission will make further modules available once they are functional.