On 8 February 2021, the European Commission published guidance concerning identification and management of legacy devices.
The European Commission has published guidance to aid in the management of the new so-called legacy devices (LD). The guidance provides detailed answers as to how LDs will be identified in the new database for the registration of devices ”EUDAMED”. Furthermore, the guidance explains how the unique identification codes for each LD will be assigned. This article provides a brief outline of the most important issues in the guidance.
General information about legacy devices
LDs are defined as medical devices, implantable medical devices and medical devices for in vitro fertilisation covered by a valid certificate issued in accordance with one of the former EU directives on medical devices and which will still be in the market after the implementation of the two new EU Regulations on medical devices (Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)).
It is possible for manufacturers to register an LD in EUDAMED. Registration is mandatory in cases where a serious incident takes place or where a related field safety corrective action is reported. In these two cases, manufacturers must effect registration as soon as possible and at least before a follow up on the incidence is effected or a final report is submitted.
Medical devices must furthermore be registered in EUDAMED if they do not within 18 months of the implementation of MDR and IVDR comply with the conditions of the regulations and are registered accordingly.
Finally, medical devices cannot be considered as LDs if the device belongs in risk group I and is not sterile or has a measurement function. In these cases, the device does not require a certificate issued by an authorising body, and accordingly, it merely has to be registered as a new device under the regulation (Regulation Devices) in EUDAMED within 18 months of the implementation of the MDR and the IVDR, respectively.
Identification of Legacy Devices
LDs are subject to the registration requirements following from the MDR and the IVDR. However, certain exceptions apply, e.g. in the form of the issue of so-called ”Basic UDI-DI” and ”UDI-DI”.
If the issue of a Basic UDI-DI/UDI-DI is not required for an LD, a requirement will still exist for the issue of a so-called ”EUDAMED DI”, which corresponds to a Basic UDI-DI. The object thereof is to uphold the same standard structure and the same identification element for all devices registered in EUDAMED.
If a UDI-DI has not already been issued, a so-called EUDAMED ID will be generated on the basis of the EUDAMED DI in question.
If on the other hand an UDI-DI already exists, the manufacturers will be able to use this as identification code. In such case, a EUDAMED DI will automatically be generated on the basis of the UDI-DI.
Against this background, only an EUDAMED DI will be issued for an LD. On the other hand, it will always be possible to identify an LD in the EUDAMED database.
In practice, an LD will thereby only have one unique identification code attached, which will either consist of a UDI-DI (where a EUDAMED DI has been generated automatically) or a EUDAMED DI (where a EUDAMED ID has been generated automatically).
Linking Regulation Devices to Legacy Devices
When a medical device corresponding to an LD meets the product requirements according to the MDR and the IVDR it must be registered as a Regulation Device.
It will, however, be possible to link an LD to a Regulation Device in EUDAMED if they have the same UDI-DI. The connection happens automatically, if the LD and the Regulation Device are identical and have been issued with the same UDI-DI. In other cases, the manufacturer can link them manually by using the identification of the LD in question.