What Is UDI Labeling?

UDI labeling (Unique Device Identification) is an alphanumeric code used to uniquely identify a medical device throughout its entire lifecycle. Since the EU Regulations 2017/745 (MDR) and 2017/746 (IVDR) came into force, UDI has been mandatory for all medical devices and in vitro diagnostic medical devices placed on the EU market. The aim is to ensure complete traceability, enable rapid identification in the event of incidents and improve market surveillance. Custom-made devices and products intended for clinical investigations are the only exceptions.

Structure of the UDI Code

A UDI code consists of two main components, supplemented by a third component in Europe:

• UDI-DI (Device Identifier): Unique identifier for a specific product model. It remains constant throughout the lifecycle of a model as long as no significant changes are made. It serves as the key in the UDI database.
• UDI-PI (Production Identifier): Identifies the individual production unit through information such as a serial number, lot number, manufacturing date, expiration date or software identification.
• Basic UDI-DI: An EU-specific requirement. It is the primary identifier for a product model at the level of the unit of use and the main grouping characteristic in EUDAMED, the European database on medical devices.

The UDI must be applied to the label in both machine-readable form (AIDC – Automatic Identification and Data Capture, for example as a GS1 DataMatrix or GS1-128) and human-readable form (HRI – Human Readable Interpretation). In cases of significant space limitations, the human-readable form may be omitted.

Issuing Entities

The UDI-DI and Basic UDI-DI are not freely assigned by the manufacturer. They are obtained through issuing entities designated by the European Commission. Currently, four organizations are accredited:



• GS1 – globally established standard, based on GTIN
• HIBCC – Health Industry Business Communications Council
• ICCBBA – for products of human origin
• IFA GmbH – Information Centre for Medicinal Products

The UDI-PI, i.e. the production-specific component, is assigned by the manufacturer itself.

Deadlines for UDI Labeling

The requirement to apply a UDI is being introduced according to risk class and product type. For medical devices under the MDR, the following deadlines apply to UDI carriers on product labeling:

• Class III and implantable devices: since May 26, 2023
• Class IIa and IIb: since May 26, 2025
• Class I: from May 26, 2027



For reusable devices requiring Direct Part Marking (DPM) directly on the product, additional deadlines apply, generally two years after the respective deadlines listed above. In vitro diagnostic medical devices under the IVDR are subject to separate, phased deadlines.

Technical Implementation on the Label

In industrial practice, UDI is generally applied using specialized barcode labels for medical devices and three basic methods:

• Label with printed barcode: The standard method for most medical devices. GS1 DataMatrix (2D) or GS1-128 (1D) are commonly used.
• Direct marking: Laser or ink marking directly onto reusable products such as surgical instruments.
• Multi-level labeling: The UDI is applied to each packaging level – from the individual product and outer packaging through to the shipping packaging, often using durable OnMould barcode labels for reusable containers and trays. Shipping containers themselves are exempt.

In addition to the UDI, the label must contain other MDR-compliant mandatory information, including the manufacturer's details, where applicable the EU representative, symbols in accordance with EN ISO 15223-1, and product-specific information such as lot number or expiration date.

Requirements for UDI Labels

From a regulatory perspective, clear requirements apply to the manufacturer of the label:

• Scan quality: The machine-readable representation must achieve Grade B or better in accordance with ISO/IEC 15415 (2D) or ISO/IEC 15416 (1D).
• Durability: The printed information and adhesive must remain readable throughout the entire product lifecycle – including after sterilization processes such as autoclaving, gamma irradiation or ethylene oxide sterilization. This may require the use of highly durable InMould barcode labels.
• Substrate compatibility: The label must provide permanent adhesion to the intended packaging material (Tyvek, film, cardboard, glass, plastic). Self-adhesive OnMould barcode labels can be customized for specific applications.
• Supplier qualification: Medical device manufacturers are required to qualify their label suppliers as part of their quality management system.

UDI Labeling at
Plöckl Media Group

Plöckl Media Group GmbH develops UDI-compliant labeling solutions for the pharmaceutical industry and other manufacturers of medical devices and IVDs – with GS1 DataMatrix or GS1-128, optionally combined with security features such as a VOID effect for tamper-evident sealing in accordance with EU Directive 2016/161.

Material selection and adhesive systems are tailored to the sterilization process, substrate and required service life, drawing on the complete portfolio of specialized labeling solutions. Each specification is approved with an initial sample inspection report. Production takes place in Germany and is certified according to ISO 9001 and ISO 14001, backed by expertise in RFID, barcode and printed security solutions.

FAQ About UDI Labeling

What does UDI mean?

UDI stands for Unique Device Identification. It is an alphanumeric code that enables each medical device to be uniquely identified throughout its lifecycle.

Which products require UDI labeling?

The UDI requirement applies to all medical devices covered by EU Regulation 2017/745 (MDR) and all in vitro diagnostic medical devices covered by Regulation 2017/746 (IVDR) that are placed on the EU market. Exceptions include custom-made devices and products intended for clinical investigations or performance studies.

What components make up a UDI?

A UDI consists of the UDI-DI (Device Identifier – identifies the product model) and the UDI-PI (Production Identifier – identifies the production unit through information such as serial number, lot number, manufacturing date or expiration date). In the EU, the Basic UDI-DI is additionally required as the overarching product model identifier.

Who assigns the UDI?

The UDI-DI and Basic UDI-DI are obtained through issuing entities accredited by the European Commission: GS1, HIBCC, ICCBBA and IFA GmbH. The manufacturer assigns the UDI-PI itself based on its production data.

When does the UDI requirement apply?

The requirement to apply a UDI to the product label is being introduced according to risk class: Class III and implantable devices since May 26, 2023; Class IIa and IIb since May 26, 2025; and Class I from May 26, 2027. For direct marking of reusable devices, the corresponding deadlines generally apply two years later.

Which barcode formats are approved for UDI?

In practice, GS1 DataMatrix (2D) and GS1-128 (1D) are primarily used, as with barcode labels for a wide range of applications. For direct marking of reusable instruments, GS1 DataMatrix is particularly common due to its compact size. Both the machine-readable and human-readable formats must be present on the label, unless the applicable space limitation exception applies.

What is EUDAMED?

EUDAMED is the European Database on Medical Devices. Manufacturers must register their medical devices in EUDAMED with the Basic UDI-DI, UDI-DI and associated product information in accordance with the applicable regulatory requirements. For labeling, they can rely on comprehensive RFID and barcode solutions from PMG.

What requirements must a UDI label meet?

The label must achieve a scan quality of at least Grade B in accordance with ISO/IEC 15415 for 2D codes or ISO/IEC 15416 for 1D codes. The print quality and adhesive must remain readable and securely bonded throughout the entire product lifecycle, including after sterilization processes such as autoclaving, gamma irradiation or ethylene oxide sterilization. The label supplier must be qualified as part of the manufacturer's quality management system.