Barcode and Labelling Systems Supporting UDI and FMD Requirements

Pharmaceutical and healthcare manufacturers operate within clearly defined identification and labelling requirements. Whether supplying the NHS, exporting to the EU or United States, or distributing medical devices and prescription medicines, barcode structure and print quality must meet recognised standards.

Weyfringe supplies barcode printers, labelling software, verification systems and suitable label materials to support organisations working to GS1 standards, Unique Device Identification (UDI) legislation and the Falsified Medicines Directive (FMD).

Our role is to help production, engineering and quality teams implement reliable barcode printing and verification processes within their existing manufacturing and packaging operations.

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NHS, medical & medical device manufacturing-1

Supporting Unique Device Identification (UDI)

Unique Device Identification legislation, developed through the International Medical Device Regulators Forum (IMDRF) and implemented by regulators including the FDA, European Commission and NHS, requires medical devices to carry structured barcode data.

If you supply medical devices to the NHS, export to mainland Europe or the United States, or distribute within regulated healthcare systems, your products may be required to carry barcodes containing defined data elements.

GS1 has been accredited as a Device Identifier (DI) issuing agency. GS1 standards define:

The barcode symbols to be used (1D and 2D)
The product data elements included within the barcode
Identification at each packaging level (single unit, multi-pack and case)

In the UK, the NHS uses GS1 DataMatrix barcodes, sometimes referred to as NHS UDI barcodes.

We supply barcode verification systems including the Axicon Series 15000 verifier, which can:

Confirm correct use of GS1 Application Identifiers (AIs)
Analyse barcode data structure
Indicate suitability for retail, distribution, point of sale or bedside scanning

This supports organisations checking barcode format and quality prior to release.

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Falsified Medicines Directive (FMD) Labelling

2D barcodes for falsified medicines directive (FMD) requirements

Under the Falsified Medicines Directive (EU 2016/161), prescription medicines placed on the market must carry:

A Unique Identifier (UI) encoded in a 2D DataMatrix barcode
A tamper-evident feature on the packaging

The Unique Identifier must contain:

Product code
Unique serialisation number
Expiry date
Lot or batch number

This information is encoded within a single GS1-compliant 2D DataMatrix barcode and is typically accompanied by human-readable text.

We supply systems that support FMD labelling processes, including:

Thermal printers suitable for 300dpi and increasingly 600dpi printing for dense 2D DataMatrix codes
Labelling software for creating GS1-compliant 2D barcodes
2D barcode verifiers capable of grading and analysing printed codes

Axicon verifiers can provide pass/fail results or detailed grading analysis, helping identify non-conforming barcodes before products enter the supply chain.

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Pharmacode and Pharmaceutical Barcode Verification

Pharmaceutical packaging often includes Pharmacode (Laetus) for internal production control and carton verification.

We supply verification systems capable of analysing:

Linear (1D) barcodes
ECC200 DataMatrix
GS1 DataMatrix containing Application Identifiers
Pharmacode used in pharmaceutical production

Verification helps production and quality teams detect structural or print quality issues early, reducing the risk of rejected product or relabelling.

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Labelling Software and Print Process Control

Structured barcode creation and consistent data handling are central to pharmaceutical labelling processes.

We supply EasyLabel barcode creation software capable of:

Creating GS1-compliant 2D DataMatrix barcodes
Managing structured variable data
Controlling user access and permissions
Maintaining print history records

For example, Easylabel software supports:

On-screen design of FMD-compliant labels
User sign-on control
Print history monitoring to record who printed what and when

These features support internal process documentation and oversight

Label Materials and Print Performance in Healthcare Environments

Healthcare labelling applications may require materials suited to:

Cartons, plastics, vials and coated substrates
Temperature-controlled storage
Handling, transport and distribution conditions

We supply label and ribbon combinations matched to application requirements, including exposure to light, heat, friction and storage conditions.

Printer resolution and ribbon selection are specified to ensure consistent 2D DataMatrix clarity and barcode readability.

Pharmacy and Healthcare Label Supply

Alongside complete barcode and verification systems, we supply commonly used healthcare label formats.

We stock 70mm x 35mm pharmacy prescription labels, available for next-day delivery across the UK. This supports pharmacies and healthcare providers requiring reliable access to standard dispensing label sizes.

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Supporting Production, Engineering and Quality Teams

Maintain consistent 2D DataMatrix and linear barcode print quality
Reduce relabelling caused by unreadable or incorrectly structured codes
Standardise label formats across product ranges

Why Pharmaceutical and Healthcare Organisations Work with Weyfringe

Over 60 years of experience

Over 60 years supplying barcode and labelling systems in the UK

Industry Insight

Experience supporting GS1, UDI and FMD labelling processes

Complete System Support

Practical understanding of regulated production and healthcare logistics and solution-led specification, installation and long-term technical support