Building a Medical Devices Database with Synchronization to EUDAMED

Project Goal

In our project we needed to create a database containing a large number of medical devices from different manufacturers, together with up-to-date information about their approval for sale and use within the European Union.

The EU provides such information through a central registry called EUDAMED (European Database on Medical Devices). This database became the natural reference point for our solution, as it contains the essential regulatory and technical details of medical devices marketed in the EU.

What is EUDAMED

EUDAMED is the official European Union database that collects and provides structured information about medical devices, in vitro diagnostic devices, manufacturers, clinical investigations, certifications, and safety issues.

It is part of the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). EUDAMED’s role is to:

• Improve transparency for regulators, healthcare providers, and the public
• Support market surveillance and traceability of medical devices
• Provide information about approvals, updates, recalls, and compliance with EU law

EUDAMED data is organized around two main identifiers:

• Basic UDI-DI: a device group identifier that represents a family of related devices
• UDI-DI: a specific identifier for each individual device in the market

This structure enables regulators and companies to track both the overall product family and individual marketed devices.

Database Schema Design

We aimed to build a medical devices database that links and synchronizes with EUDAMED.

However, EUDAMED’s native structure is not well suited for relational database design. Therefore, we designed a classic hierarchical schema that better reflects our needs while still corresponding closely to the EUDAMED structure:

• Manufacturers are the top-level entities
• Device Groups (Basic UDI-DI level) are linked to manufacturers
• Devices (UDI-DI level) are organized under device groups

Manufacturer Table

Stores information about device manufacturers or authorized representatives.

DeviceGroup Table (Basic UDI-DI level)

Represents a group of related devices.

Device Table (UDI-DI level)

Represents individual devices within a group.

This schema keeps the logical hierarchy: Manufacturer → Device Group → Device, while remaining flexible enough to store complex EUDAMED attributes.

Synchronization with EUDAMED

EUDAMED provides several official approaches for organizations to work with its data:

1. Machine-to-Machine (M2M) API Integration

EUDAMED exposes secure M2M APIs that allow companies to exchange data directly with the system. Access, however, is restricted and requires official registration. There are two main ways to obtain this access:

• Apply through national authorities - Companies can submit a request to their local regulatory institution, pass verification, and then receive direct API access. This channel is primarily targeted at large manufacturers.
• Partner with an existing access holder - Smaller organizations can sign an agreement with a larger company that already has access, effectively using their access point as a third-party service.

Both paths enable read and write operations, but the registration and verification process can be complex and not suitable for every project.

2. Bulk Download via User Interface

For projects that do not require large-scale automated synchronization, EUDAMED also provides a bulk export functionality through its public user interface. Users can download datasets in JSON format, containing device and manufacturer information. These datasets are structured, machine-readable, and can be processed to update local systems.

This method is particularly suitable for smaller projects where:

• The number of records to synchronize is relatively low (e.g., fewer than 1,000 devices per session)
• Updates are needed on a weekly or monthly basis rather than in real-time
• Full M2M API access would be excessive or administratively impractical

In our case, we require only periodic synchronization of under 1,000 records per session, making the bulk download approach the most efficient solution.

Although EUDAMED’s bulk download feature is exposed via its web interface, the data is delivered through endpoints that return JSON content. By analyzing the UI network calls, we identified three relevant services:

• Search Endpoint:
  https://ec.europa.eu/tools/eudamed/api/devices/udiDiData
• Device Group Endpoint (Basic UDI-DI level):
  https://ec.europa.eu/tools/eudamed/api/devices/basicUdiData/{basicUdiDiId}
• Device Endpoint (UDI-DI level):
  https://ec.europa.eu/tools/eudamed/api/devices/udiDiData/{deviceId}

Using these, we can search for a device, retrieve details for its Basic UDI-DI group, and download detailed information for each specific UDI-DI device. This allows us to synchronize our local relational database with EUDAMED on a regular schedule, ensuring that the information about medical devices remains accurate and compliant with EU regulatory data.