What UK Medical Device Manufacturers Need to Know About UDI

What is a UDI?

A Unique Device Identifier (UDI) is a globally recognised code that allows every medical device to be identified throughout its lifecycle. It is made up of two specific elements.

• UDI-DI (Device Identifier): the fixed part, specific to a model or version of a device and linked to its key information in a database.
• UDI-PI (Production Identifier): the variable part, covering batch or lot number, serial number, software version, or expiry date.

Together they make a single identifier. This must be shown in two forms.

• Human-readable interpretation (HRI) — plain text on the label.
• Automatic identification and data capture (AIDC) — usually a barcode or data matrix that scanners can read.

Manufacturers are responsible for generating the UDI. They also submit the relevant information to the appropriate database (e.g., EUDAMED for the EU), and place the UDI “carrier” on the label. It is also possible to put them directly on the product.

A third component you may encounter is the Basic UDI-DI. This is not printed on the label; instead. It acts as a sort of master key by linking a group of devices with the same intended purpose and risk class to their technical files and certificates.

The concept is international and driven by the IMDRF UDI guidance. Each jurisdiction has its own issuing bodies and compliance deadlines. In Europe, GS1, HIBCC, ICCBBA and IFA are authorised to issue UDIs.

Why Does It Matter? The Benefits of UDIs

Introducing UDI may seem like extra administration. It is not just for the sake of it as its benefits are tangible across safety and commercial reach.

Patient Safety and Post-Market Checks

UDIs make it far easier to trace a device if safety concerns arise. Hospitals and distributors can track precisely which batch or serial number is in use. The use of these labels can speed up field safety notices or recalls. It can also reduce the chances of unsafe products being used by mistake. Patient safety is always a priority.

They reduce medical errors by helping clinicians verify they have the correct product at the point of care.

Regulatory and Market Confidence

A functioning UDI system is needed for compliance with EU MDR 2017/745, IVDR 2017/746 and also the UK’s post-Brexit rules. The responsibility for medical device labeling has been transferred to the Medicines and Healthcare products Regulatory Agency (MHRA).

Accurate identifiers also make regulatory reporting far more effective. If a safety alert or a malfunction is raised, authorities can see exactly which model. They can also see the batch or serial number that is involved. That level of clarity supports faster investigations and lets trends in adverse events be spotted sooner.

Supply Chain and Stock Management

Warehouses and hospitals can use this technology to help automate inventory processes and cut down on manual entry and mistakes.

UDIs help control obsolescence and waste. The devices nearing expiry can be identified easily. It is far easier for companies to know what is going on with all of their equipment.

For companies managing both UKCA- and CE-marked inventory, a robust UDI process also reduces confusion over artwork versions and packaging for different markets.

Brand and Commercial Trust

Healthcare providers, distributors and notified bodies increasingly expect clear and scannable identifiers on packaging. They may also expect it on the device itself. A professional UDI implementation signals that your business takes traceability and quality seriously.

It also protects your brand by making it harder for counterfeit or diverted goods to circulate. A valid code linked to an authoritative database allows partners to check authenticity. Things like tamper-resistant printing and durable materials help maintain legibility throughout the product’s life. This visibility supports strong commercial relationships and makes tenders or procurement exercises smoother, as customers can see your commitment to compliance and safety.

Building a Secure, Global Distribution Chain

By embedding a recognised identifier on every product and package, UDIs strengthen the integrity of supply chains. They make it easier to confirm a device’s origin and intended market.

This becomes especially valuable in public health emergencies. If rapid distribution of life-saving devices is needed, it relies on confidence that every item is authentic and properly documented.

Many manufacturers find that UDIs issued by globally recognised entities such as GS1 also simplifies customs checks and helps products move quickly through the approved channels.

Contributing to an International Identification Standard

UDI is part of a broader shift toward a single, global language for medical device identification. Regulations in most parts of the world are tending to use the same core principles and even share issuing bodies.

Adopting UDIs aligned with these standards means medical devices are ready for acceptance in multiple parts of the world. They won’t necessarily need re-labelling or extra verification steps if a global standard is born.

Regulations on UDIs

It is really important to know exactly where you stand in terms of rules and regulations. All medical manufacturers have to keep a close eye on compliance (often for numerous markets).

The EU framework

The European Union introduced UDI through the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. These rules apply to almost all devices except custom-made and investigational products.

Key obligations for manufacturers include:

• Assign a UDI-DI and UDI-PI to each device and its packaging levels.
• Place the UDI carrier on the label or. In some situations it can be placed directly on reusable devices.
• Submit core data elements to the EUDAMED database.
• Keep records up to date within 30 days of any changes.

Compliance deadlines were staggered by device class and as you can see from the graph below, compliance is already required for some devices. UDIs are already required on all relevant device labels. For medical devices under the MDR:

IVD devices follow similar staged dates under the IVDR.

UKCA, CE and the Northern Ireland position

Brexit brought extra layers to consider for manufacturers. Manufacturers may now have to separate production and labelling in order to comply with MHRA and EMA guidelines if they supply to EU and GB markets.

Great Britain (England, Scotland, Wales) uses the UKCA mark for placing devices on the market. Although UKCA does not yet mandate UDI in the same way as the EU, the MHRA has consulted on adopting a new system. It is expected that this will align with international formats. A proposed framework’s “requirements include having English language labelling and packaging, a UK Responsible Person, a unique device identifier (UDI), and complying with post-market surveillance (PMS) requirements.”

Northern Ireland remains under EU MDR/IVDR rules due to the Windsor Framework. Devices there must meet CE-marking and UDI requirements if they fall within scope.

Manufacturers who want GB and EU access may need packaging that carries both UKCA and CE marks, plus space for UDI barcodes and text. Choosing label materials that resist smudging and fading is also a must.

The UK law accepts CE-marked devices until mid-2030 (with some exceptions), but future legislation is likely to tighten UDI expectations. Building UDI into your artwork and ERP systems now is the safest route and the best chance of a simple process.

Issuing Entities and Databases

UDI codes are allocated by bodies designated in each market:

• EU: GS1, HIBCC, ICCBBA, IFA
• US FDA: accredits GS1, HIBCC, ICCBBA
• Other markets may have their own lists, but most recognise one or more of these organisations.

Device data for the EU must be uploaded to EUDAMED. It is possible that the UK is considering a similar repository as part of its future regulations.

Practical compliance tips for UK manufacturers

• Map which markets each device serves (GB, NI, EU, US, etc.) and align UDI formats early.
• Allow generous label real estate for CE, UKCA, recycling symbols and the UDI carrier.
• When sourcing labels, test durability against sterilisation, abrasion and cleaning agents.
• Keep a robust version-control process: link artwork updates to your device master record and UDI information.
• Train teams across QA, RA, packaging and IT so they understand how UDIs flow through the organisation.

UDI Support From Dura-ID Solutions

Accurate and durable labelling isn’t just a regulatory box to tick. It protects patients and proves your commitment to quality. At Dura-ID Solutions, we design and manufacture high-performance labels and tags that stand up to the demanding conditions of healthcare and medical manufacturing.

We can support you through the process of creating UDI labels that fit the requirements for both machine-readable and human-readable formats.