The European Commission has published a guidance document aiming to further assist manufacturers with understanding how Legacy Devices can continue to be placed on the market once the Medical Devices Regulations (“MDR”) and In Vitro Diagnostic Medical Devices Regulations (“IVDR”) come into force. The guidance document focuses on some of the intricacies of the European Databank on Medical Devices ("EUDAMED") database, the driving force behind the new regulation.
For the purposes of this note:
- A 'Legacy Device' is a device that is registered under the Medical Devices Directive (“MDD”) or In Vitro Diagnostic Medical Devices Directive (“IVDD”). It has a valid certificate issued to it in accordance with the relevant regulations and continues to be placed on the market following the MDR and IVDR coming into force.
- A 'Regulation Device' is a device that has fulfilled all MDR or IVDR requirements (as applicable) that are required to obtain the MDR or IVDR certificate which verifies that a device meets all regulatory requirements.
Once the EUDAMED database is fully functional, manufacturers will, on a voluntary basis, be able to register any of their Legacy Devices on it. It should be noted that registration will become mandatory in the event that a serious incident occurs or there is a field safety corrective action to apply.
The guidance document has been particularly helpful in addressing administrative issues, such as how the registration of devices on the EUDAMED database will be dealt with when a device transitions from being a Legacy Device to a Regulation Device. It explains that when the equivalent of a Legacy Device becomes a compliant Regulation Device, even if the Legacy Device was registered, a new Regulation Device shall be registered in EUDAMED. However, in order to streamline the process, EUDAMED will allow the linking of the Regulation Device with the Legacy Device. If the Regulation Device is exactly the same as the Legacy Device, the Regulation Device may be assigned the same Unique Device Identification - Device Identifier ("UDI-DI"). In this case, the link between the two devices will be made automatically, otherwise the manufacturer will be permitted to create the link manually by providing the Legacy Device identifier.
More information can be found in the guidance document.