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TL;DRUDI (Unique Device Identification) is the identification system for medical devices under the EU Medical Device Regulation (EU) 2017/745 and the IVDR (EU) 2017/746: a globally unique numeric or alphanumeric code, carried on the device label and registered in the EUDAMED database, that unambiguously identifies a specific device on the market.
This entry covers only the medical device meaning. The acronym UDI is also used in unrelated fields such as unified diagnostic interfaces and generic device drivers, and none of that applies here. In pharmaceutical and healthcare supply chains, UDI is the regulated traceability code that a manufacturer assigns to a Medizinprodukt or an in-vitro diagnostic, so that the same physical device can be recognised by hospitals, wholesalers, notified bodies and market surveillance authorities across the EU.
A UDI is not a single flat number. It is composed of two elements that answer two different questions, which one is this model and which production run is this unit from. Sitting above both is the Basic UDI-DI, a grouping key used for regulatory documentation rather than for labelling.
| Element | Full name | Nature | What it identifies |
|---|---|---|---|
| Basic UDI-DI | Basic Device Identifier | Static, not on the label | The main access key in EUDAMED and in technical documentation. It groups devices with the same intended purpose, risk class and comparable design and manufacturing characteristics, roughly a product family. |
| UDI-DI | Device Identifier | Static | A single device model or configuration and its manufacturer. It is unique at each packaging level and acts as the fixed key that links to the model and manufacturer data. |
| UDI-PI | Production Identifier | Variable | The specific production data of the individual unit: lot or batch number, serial number, expiry date, date of manufacture and, for software, the version. |
On the physical device the UDI-DI and UDI-PI together form the UDI carrier, a machine-readable barcode or Data Matrix accompanied by a human-readable line, applied to the label and, for reusable devices, to the device itself.
Manufacturers do not invent UDIs freely. Each UDI-DI is created within the coding system of an issuing entity designated by the European Commission. Four entities are designated for both the MDR and the IVDR.
IFA GmbH, already known in Germany as the body behind the PZN, is the only one of the four issuing entities based in the EU. It was designated as a UDI issuing entity by Commission Implementing Decision (EU) 2019/939 of 6 June 2019.
A medical device is legally not a medicinal product, so it is not governed by the Falsified Medicines Directive product code that identifies a medicine pack. Its regulated identity is the UDI-DI under the MDR, not a securPharm PZN-in-Data-Matrix. In German trade and reimbursement, however, a Medizinprodukt is very often still ordered and settled under a PZN, and where the GS1 route is used the device UDI-DI is a GTIN. So one device can sit in two identifier worlds at once: a UDI-DI for MDR traceability and a PZN for the German ordering and settlement chain, with the GTIN as the shared GS1 bridge.
This is where an aggregated article-master-data view helps. On pharmazie.com a Medizinprodukt is flagged as such in the legal status of the article, and the article base data held per PZN can map to a device UDI-DI where the licensed data set provides it.
One honest limitation: pharmazie.com is a licensed data aggregator, not an issuing entity and not an EUDAMED outlet. It carries the Medizinprodukt classification and the PZN-anchored article data, but it is not a substitute for the official UDI database. Whether a full UDI-DI or Basic UDI-DI value is exposed for a given device depends on the underlying licensed data, and the authoritative UDI record is EUDAMED, taken at the source.
