On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance complements the guidance concerning the registration of legacy devices in EUDAMED issued by the European Commission on 15 April 2019.
Legacy devices are devices that are covered by a valid certificate issued in accordance with Directive 93/42 concerning medical devices, Directive 90/385 on the approximation of the laws of the Member States relating to active implantable medical devices, or Directive 98/79 on in vitro diagnostic medical devices (“the Medical Devices Directives”) and that continue to be placed on the market after the date of application of Regulation 2017/745 on medical devices (“MDR”) or Regulation 2017/746 on in vitro diagnostic medical devices (“IVDR”).
The guidance clarifies that class I medical devices that are not sterile and/or do not have a measuring function under the Medical Devices Directives cannot be considered as legacy devices because they do not require a certificate issued by a notified body.
Registration of legacy devices in EUDAMED
Manufacturers will be able to voluntarily register their legacy devices in EUDAMED. The EUDAMED module on UDI/device registration is expected to be available by May 2021.
Registration will only be mandatory where a serious incident occurs or where a related field safety corrective action (“FSCA”) must apply. In these cases, registration of the device will be required as soon as possible and at least before a follow up or final vigilance report is submitted.
Identification of legacy devices
The MDR and the IVDR introduce an EU identification system for medical devices based on a Unique Device Identifier (“UDI”).The European Commission recalls in its guidance that it is unnecessary to assign a Basic UDI-DI and a UDI-DI to legacy devices.
The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market. The UDI is comprised of the UDI device identifier (“UDI-DI”) and the UDI production identified (“UDI-PI”).
The Basic UDI-DI is intended to identify and connect devices with the same intended purpose, risk class and essential design, and manufacturing characteristics. It is the main access key for device-related information in the EUDAMED database.
The guidance recalls that although the assignment of a Basic UDI-DI is not required for legacy devices, an identification element EUDAMED DI (the equivalent of the Basic UDI-DI) will be required. Furthermore, in case no UDI-DI has been assigned to the legacy device, a EUDAMED ID (the equivalent of the UDI-DI) will be generated from the EUDAMED DI.
Therefore, either a UDI-DI or a EUDAMED ID must be used to identify a legacy device in EUDAMED. However, a Basic UDI-DI will never be assigned to legacy devices.
Linking the devices compliant with the MDR or the IVDR to legacy devices
When a certificate issued under the MDR or the IVDR is provided for a legacy device, EUDAMED will allow a link to be made between devices that are compliant with the MDR or the IVDR and the legacy device.
This link will be automatically done where the same UDI-DI has been assigned to both the legacy device and the device compliant with the MDR or the IVDR. This will be the case when the device is exactly the same as the legacy device, apart from the fact that it is covered by a certificate under the MDR or the IVDR.
If the legacy device and the device compliant with the MDR or the IVDR do not have the same UDI-DI, the manufacturer will still be able to manually establish the link by providing the legacy device identifier.
Authored by Elisabethann Wright and Silvia López Arnao