The EU Commission released a consultation regarding creation of a ‘Master UDI-DI’ for ‘highly individualized devices’, located: HERE
What exactly does this mean and how does this impact you?
The EU Commission is proposing to introduce a new term and principle (‘Master UDI-DI’) for certain types of medical devices.
What is the purpose of the Master UDI-DI?
The purpose of the Master UDI-DI is to group together devices that have a high-level of individualization, in order to reduce the number of entries made into the EUDAMED device registration system.
The example in the consultation is contact lenses. These products may require a large number of UDI-DIs, and therefore have a disproportionately high number of EUDAMED entries, even though there is no clinical or regulatory value of having so many individual registrations for each device. Therefore, in order to allow manufacturers to meet their obligation of applying a UDI and then registering those devices into EUDAMED, those manufacturers may assign a Master UDI-DI to the qualifying products and submit a single EUDAMED registration.
For more information read: Registering Devices in EUDAMED
Which devices are considered ‘highly individualized’?
At this time, the product type under consideration as a ‘highly individualized device’ is contact lenses. However, the Commission is leaving the possibility for other types of devices to be categorized as such, if needed in the future.
What is the impact on your company?
The impact of the Master UDI-DI proposal is minimal for most of the industry.
The impact for contact lens manufacturers would require a restructuring of their current UDI system, to implement the Master UDI-DI. Contact lens manufacturers should review the amendment text (Part C of Annex IV) which outlines the criteria for Master UDI-DI assignment.
How does the Master UDI-DI relate to the Basic UDI-DI?
The ‘Master UDI-DI’ is not to be confused with the ‘Basic UDI-DI’. The Master UDI-DI is not replacing the Basic UDI-DI. These are two different things.
The Basic UDI-DI is required for all MDR CE marked medical devices. Therefore, manufacturers will need to consider if the device should additionally have a Master UDI-DI. i.e., if a device is considered ‘highly individualized’ and eligible for a Master UDI-DI, then it needs both the Basic UDI-DI and the Master UDI-DI.
For more information read: Basic UDI-DI
When will this go into effect?
The consultation is open for feedback until 19 April 2023. After the feedback period is closed, comments may be taken into consideration, i.e., the proposed amendment may undergo revision. The amendment must then pass through the normal channels, until it is eventually published in the Official Journal of the European Union (OJEU). Once published, per the amendment, it will go into effect two (2) years from its date of entry.