The new European Union (EU) medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), originally published in 2017, sets forth more stringent requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU.
These regulations, which will replace decades old legislation, require manufacturers to make significant changes in product development, data reporting and quality assurance.
With expanded clinical evidence requirements and increased regulatory requirements, the transition to comply with these directives can be challenging. To complicate the process further, there will be no grandfathering of legacy devices, which are defined as products covered by certificates issued in accordance with the outgoing directives but placed on the market after the new regulations take effect. These devices are subject to most of the incoming regulatory requirements, but carry a set of unique considerations.
To help manufacturers navigate this, The European Commission has published guidance on the management and registration of legacy devices in the EUDAMED database. Here we summarise the key points of the guidance, including identification requirements for legacy devices, when manufacturers need to register devices on EUDAMED and how to link products covered by the outgoing and incoming regulatory frameworks.
Identification requirements under MDR/IVDR
Once made compliant with MDR/IVDR, legacy devices will have to follow MDR/IVDR registration requirements with the EUDAMED database in case a serious incident occurs or there is a field safety corrective action to apply. However, these devices may not necessarily have to be assigned Basic UDI-DI and UDI-DI codes, which are the primary identifiers of each unique device.
For example, in some instances, legacy devices have already been assigned UD-DI codes prior to implementation of the new regulations, which may be used for EUDAMED registration and identification purposes. In this case, the EUDAMED DI is automatically generated from the existing UDI-DI value. The Legacy Device will therefore have the following identification elements:
- A UDI-DI (assigned by the manufacturer)
- A EUDAMED DI (generated based on the UDI-DI)
Implementation of the EUDAMED database will be conducted in phases, launched in May 2021. The target date to complete applications is set for May 2022.
Linking the regulation devices to legacy devices
The EUDAMED database supports the linking of new devices with legacy devices and their successors. If a MDR/IVDR compliance device is exactly the same as the legacy device, the products may share the same UDI-DI. As such, linking will occur automatically based on UD-DI information upon registration with EUDAMED. If the products are not identical aside from MDR/IVDR compliance or no UDI-DI has been pre-assigned, the manufacturer will need to provide the legacy device identifier to manually link the products.
Additional considerations
If an equivalent device is not made compliant and registered as a MDR or IVDR device within 18 months after the date of MDR/IVDR application, the legacy device must be registered in EUDAMED. Moreover, legacy devices falling within risk class I that are not sterile cannot be considered as legacy devices because they do not require a certificate issued by a Notified Body. Instead, these devices must be registered only as regulation devices in EUDAMED within the 18 months after the date of application.
ICON’s Medical Device and Diagnostics Research team has over 30 years of clinical development & commercialisation service experience with medical device and IVD companies.