Custom UDI integration development
Appfront builds integrations for UDI, the unique device identification of medical devices under the MDR and IVDR. Manufacturers register their devices with UDI data in EUDAMED, the European database, and its UDI module has been mandatory for new devices since 28 May 2026. We integrate your own product management with EUDAMED and your labels, so UDI data is accurate in one place and not entered by hand.
What is a UDI integration?
Under the European regulations for medical devices, the MDR and the IVDR, devices are given a unique identifier, the UDI. It consists of a fixed part for the model or version, the UDI-DI, and a part for production, such as a lot number or serial number. There is also a Basic UDI-DI for the product group. The UDI appears on the label and packaging, and the data is registered in EUDAMED, the European database.
The UDI module of EUDAMED has been mandatory since 28 May 2026: new devices must be registered before they are placed on the market, and a transitional period applies to devices already on the market. In practice, product data sits in an ERP or product information system and is entered into EUDAMED by hand or uploaded via a file. A change to a product does not always lead to a new UDI-DI where one was required.
We build custom solutions because businesses differ: how many devices you have, where the product data is held, which issuing entity you use, and how labels are produced. Which data you must register and when follows from the MDR, the IVDR and the European Commission's guidance; if in doubt, check this with your regulatory affairs specialist or adviser.
From your product management
UDI data in one place, in your own product management or ERP, rather than in separate lists.
To EUDAMED
Registration and updates in the UDI module, with checks for missing or incorrect data.
On the label
The same UDI on the label and packaging, and changes that require a new UDI-DI flagged.
How we build your UDI integration
We start with your devices: how many, where the product data is held, which issuing entity, how labels are produced, and how registration works today. Often not all the data EUDAMED asks for is already in your own system. We map this out so it is clear what needs to be added and by whom.
Your products, data, issuing entity, labels and systems.
Basic UDI-DIs, UDI-DIs and characteristics in your product management.
Registration in EUDAMED, and the same UDI on the label.
Alerts when changes occur, and ongoing management thereafter.
What a UDI integration actually does
The components below feature in almost every UDI integration. Which ones you need depends on your role.
UDI data
Basic UDI-DI, UDI-DI and characteristics.
Allocation
According to your issuing entity.
Registration
In the UDI module of EUDAMED.
Validation
Missing or incorrect data.
Label
The same UDI on label and packaging.
Changes
Alert when a new UDI-DI is needed.
Who we build UDI integrations for
The integration is intended for those who assign, register or record UDIs.
Manufacturers
Many devices and versions. Registration is the core.
Importers
Devices from outside the EU. Checking matters most.
Distributors
UDIs throughout the supply chain. Scanning is what is needed.
Hospitals
Implants in the patient. Recording is the core.
Technology and integrations
This page covers UDI and EUDAMED. For the technical file, see our page on an MDR technical file with PMS; for in vitro diagnostics, our page on an IVDR documentation system; and for implants, our page on an implant register. You can read about our approach at software development.
Why choose Appfront for your UDI integration?
A UDI that differs in EUDAMED from what is on the label is a problem at every inspection. That is where we focus: data in one place, registration without manual re-entry, and the same UDI everywhere.
One source
UDI data in your own system.
Less manual work
Registration without re-keying.
Consistent everywhere
EUDAMED and the label match.
Security and privacy in a UDI integration
The integration works with product data and access to EUDAMED on behalf of your organisation. Access credentials are stored encrypted and used only by the integration, and every registration is logged.
The integration runs in a European data centre or in your own environment, with encrypted storage and daily backups.
Frequently asked questions about a UDI integration
Questions manufacturers ask before they start.
The unique identification of a medical device under the MDR and the IVDR. It consists of a fixed part for the model or version, the UDI-DI, and a part for production, such as a lot or serial number. There is also a Basic UDI-DI for the product group.
The European database for medical devices, set up by the European Commission. It consists of modules, including a module for UDI and devices. That module has been mandatory for new devices since 28 May 2026.
Yes, a transitional period applies. Which deadline applies to your devices follows from the rules and the European Commission's guidance; please confirm this with your regulatory affairs specialist or adviser.
Via the ways EUDAMED offers for submitting data, such as files or a machine-to-machine connection. We'll look at which route suits your volumes and systems in the first step.
After certain changes to a device, such as a different version or packaging. The software flags changes that may require a new UDI-DI so you can assess whether that is the case. What exactly counts follows from the rules.
Yes. A hospital can scan and record UDIs of devices and implants in its own system, for example during an implantation. That way it is possible to trace later which device was used for which patient.
For manufacturers and importers with many devices or versions, who want to keep product data in their own system, and for hospitals and distributors who want to record UDIs in their own systems.
UDI data that is correct everywhere?
Tell us how many devices you have, where the product data is held and how you register them now. We'll show you what the integration with EUDAMED and your labels would look like.