EUDAMED and the Master UDI

The European Commission and the EUDAMED team have released a new version of EUDAMED to Production. This includes a significant change: the implementation of the Master UDI.

This has a significant impact on the level of data required by the Lens and Spectacle manufacturers. This is the rule as published in the business rules document.

BR-UDID-731: Master UDI-DI

Master UDI-DI is an identifier of a group of highly individualised products/devices presenting specific similarities with respect to defined clinically relevant parameters. It is applicable with REGULATION (EU) 2017/745 on medical devices only.

The following special device types require the registration of Master UDI-DI:

• Standard soft contact lenses
• Standard Rigid Gas Permeable (RGP) contact lenses
• Made to order soft contact lenses
• Made to order Rigid Gas Permeable (RGP) contact lenses

 

• A Master UDI-DI is an alphanumeric code. The system will ensure:
  There are no duplicates of a Master UDI-DI code.

 

• At the registration of a Master UDI-DI for the GS1 issuing entity, the system will also:
  Validate the format of the Master UDI-DI code when registering Master UDI-DI for the following special device types:
  • Standard soft contact lenses
  • Standard Rigid Gas Permeable (RGP) contact lenses

• for the following special device types the format of the UDI-DI for the GS1 issung entity will be applied
  • Made to order soft contact lenses
  • Made to order Rigid Gas Permeable (RGP) contact lenses

Note: Selecting any of these special device types requires the registration of a Master UDI-DI as per rule BR-UDID-731: Master UDI-DI

A comment I received from the European Commission:

When the Issuing Entity is GS1:

• The MASTER UDI-DI has the same format as the GMN code – https://www.gs1belu.org/en/global-model-number-gmn

• The UDI DI is the GTIN code.

This new addition has quite an impact on the data EUDAMED requires. So what does it mean for you?

Data Requirements Changes for Master UDI

Note: Orthopedic is no longer an available option.

By default, in EUDAMED, DIs will be considered as Master UDIs if any of the above “Special Device Type” options are selected. As a result, the requirements/abilities for adding other information differ from those for adding a normal UDI DI.

It is also possible to add a secondary Master UDI from another issuing entity using the normal Secondary UDI fields; these will be validated as Master UDIs. Again, this is automatically done based on the selection of the specific ‘Special Device Type’ options.

Under the new business rule BR-UDID-729 the following data is not required for Master UDIs

·        Unit of Use

·        DI Direct Marking UDI-DI

·        List of CMR Substances associated to Device

·        List of Endocrine Substances associated to Device

·        Related Device (Legacy- Regulation) New Device

·        List of Medicinal product substances associated to the Device

·        Tissues and cells – presence of human tissues or cells, or their derivates

·        Tissues and cells – presence of animal tissues or cells, or their derivates

For the ‘Intended purpose other than medical (Annex XVI)’ field only a Yes or No is allowed with none of the available Annex XVI options allowed, again this is only for Master UDIs.

Container Packages will also reflect the Master UDIs

We do not expect these changes to be reflected in EUDAMED Production until much later in the year, either towards the end of Q4 2024 or early in Q1 2025.

For any affected companies, we can assist with your EUDAMED requirements. Although this requirement will not be released into Production for several months, you should make your required preparations now.

If you are looking for expert EUDAMED advice, machine-to-machine (M2M), premium support, training, and data submission management, please do come and talk to us at

About EirMed

EirMed Ltd is a leading provider of EUDAMED and regulatory submission solutions for the medical technology (MedTech) industry worldwide. With a commitment to excellence and innovation, EirMed offers comprehensive solutions tailored to meet clients’ evolving needs in regulatory data submissions and data management.

If you are looking for expert EUDAMED advice, premium support, training, and data submission management, please do come and talk to us.