Every device in Europe now needs a unique, machine-readable identity. The UDI system underpins traceability, recalls and the entire EUDAMED database — and getting the structure right is a common stumbling block.
The Unique Device Identification system has two parts on the product: the UDI-DI (Device Identifier), the static code identifying the issuing entity, manufacturer and product reference; and the UDI-PI (Production Identifier), the dynamic part carrying lot or batch number, serial number, and manufacturing or expiry date.
The Basic UDI-DI
Sitting above these is the Basic UDI-DI — an EU-specific grouping identifier that links devices sharing the same intended purpose, risk class and essential design characteristics. It never appears on the label; instead it is the key reference used across the declaration of conformity, certificates, clinical evaluation, PSUR and EUDAMED. Manufacturers frequently misunderstand its role.
Issuing entities
UDIs are assigned through one of four Commission-designated issuing entities — GS1, HIBCC, ICCBBA and IFA — whose designations were renewed in 2024 to run until 2029. Most manufacturers work with GS1.
Where the UDI goes
The UDI carrier — a barcode plus a human-readable form — must appear on the device label and on all higher levels of packaging. Reusable devices that require reprocessing also need direct marking on the device itself.
The timeline
UDI carrier placement applied from 26 May 2021 for Class III and implantables, 26 May 2023 for Class IIa and IIb, and 26 May 2025 for Class I, with direct-marking obligations following two years after each date. Registration of UDI data in EUDAMED becomes obligatory with the platform’s mandatory date in May 2026.
How PQRA helps
PQRA advises on UDI structure, Basic UDI-DI grouping, labelling and registration in EUDAMED.
No responses yet