Master UDI-DI – the new EU requirements in regard to medical devices
With the implementation of the Medical Devices Regulation (MDR), it became apparent that manufacturers should assign UDI to medical devices. This is intended to allow the identification and to improve the traceability of devices, as well as to provide monitoring and to run the fighting mechanism against medical device counterfeiting.
As GS1 marked in their update about the new EU requirements for medical devices identification: “..certain devices with a high level of individualization, there is a risk of disproportionate UDI-DI (i.e. GTIN) data entries in the EUDAMED database, which limited value for regulatory purposes and risk of substantially compromising database performance.”. The solution is the implementation of Master UDI-DI. Yes, we know, it sounds like “another one requirement.”. However, it has a key role in the whole process of identification – learn more >>
1. What is Master UDI-DI?
The purpose of Master UDI-DI`s implementation is to create a new level of identification of certain products and medical devices as part of UDI requirements based on MDR (Medical Devices Regulation).
2. What business challenges are being addressed?
The main purpose is for the affected devices to be grouped with a high level of individualization. This will reduce the volume of data entries in the EUDAMED database (UDI module). Furthermore, in this regard, the additional Application Identifiers for clinical specifications have to be reviewed because there is a need to be developed in a way that will provide more granular product information.
3. Which devices are affected?
The affected devices are contact lenses, spectacle lenses and ready readers*
*These are the defined devices till the moment. The list of products with a high level of individualization will be extended.
4. What are the new requirements?
The Master UDI-DI will be placed in the UDI barcode as PI (Product Identifier) on the packaging/ label of the product. **
** The specifications and requirements of Master UDI-DI are not defined by EUDAMED yet.
5. What is the timeline of implementation?
In 2024 the registration of devices in the EUDAMED database, including the Master UDI-DI, will be possible.
To better understand the implementation dates of the forthcoming MDR and IVDR regulations, you can benefit from our Ultimate Compliance Test.
If your company has to deal with registration on EUDAMED or any other business related to MDR regulation – schedule a free meeting with our experts >>