How does UDI and EUDAMED work under EU MDR?
MDR Article 27–34 · Annex VI (UDI) · EUDAMED
The short answer
UDI (Unique Device Identification) is mandatory for all CE-marked medical devices. It provides a unique identifier for each device type and production instance. EUDAMED is the EU database where manufacturers, devices, UDIs, NB certificates, clinical investigations, and vigilance reports are registered. EUDAMED will become fully mandatory from May 2026.
UDI structure
Every UDI consists of two components:
- UDI-DI (Device Identifier): Identifies the device model/version; changes when a new version or configuration is released; assigned by an issuing entity; registered in EUDAMED
- UDI-PI (Production Identifier): Identifies the specific production unit; includes lot/batch number, serial number (for implantables), expiry date, and/or manufacture date as applicable
Both the UDI-DI and UDI-PI are placed on the device label and packaging in human-readable form and as a barcode (GS1 DataMatrix or other approved carrier).
UDI-DI registration
The UDI-DI must be registered in EUDAMED before the device is placed on the market. For dual-market manufacturers, the same UDI-DI is also submitted to the FDA GUDID (Global Unique Device Identification Database). Approved issuing entities include:
- GS1: Uses GTIN (Global Trade Item Number); most common globally
- HIBCC: Health Industry Business Communications Council; common in surgical instruments
- ICCBBA: Used for blood and tissue products
EUDAMED modules
| Module | Content | Mandatory from |
|---|---|---|
| Actor Registration | Manufacturers, ARs, importers, authorised reps | Already mandatory |
| UDI / Device Registration | Device UDI-DI, basic UDI-DI, device characteristics | Already mandatory for new devices |
| NB and Certificates | NB designations, EU certificates, certificate status | May 2026 |
| Clinical Investigations | Registration of clinical studies under MDR | May 2026 |
| Vigilance | Serious incidents, FSCAs, trend reports | May 2026 |
UDI labelling deadlines
| Device class | UDI on label mandatory from |
|---|---|
| Class III / Class IIb | Already mandatory |
| Class IIa | 26 May 2025 |
| Class I | 26 May 2027 |
Frequently asked questions
What is the difference between UDI-DI and UDI-PI?
The UDI-DI identifies the device model — it is the same for every unit of a given version. The UDI-PI identifies the specific production instance (lot, serial, expiry). Think of UDI-DI as the product catalogue number and UDI-PI as the serial or batch number. Both together form the complete UDI.
Is EUDAMED publicly accessible?
Parts of EUDAMED are publicly accessible, including the UDI database (device characteristics) and NB certificates (from May 2026). Vigilance reports and clinical investigation details have restricted access tiers. Competent authorities have full access to all modules.
How do reusable devices handle UDI?
Reusable devices that are intended for reprocessing and reuse must bear the UDI-DI on the device itself (direct marking), not only on packaging, since packaging is discarded after initial use. Specific direct marking requirements and exemptions are in Annex VI Part C.
Are custom-made devices subject to UDI?
Custom-made devices are exempt from UDI requirements under Article 27(2) MDR. They must still comply with other MDR requirements including technical documentation and the statement for custom-made devices.