How Medical Device Distributors Can Help Manufacturers Stay UDI-Compliant Before the May 2025 EU MDR Deadline

The EU Medical Device Regulation (MDR 2017/745) has fundamentally reshaped how Class I medical devices are labeled and tracked. One of the most overlooked – yet critical – areas of compliance is the UDI Carrier Label. As of 26 May 2025, all Class I devices must display a UDI (Unique Device Identifier) on their labels and higher packaging levels.

But here's the catch: many small or craft-scale manufacturers are unaware, overwhelmed, or misinformed about what this actually means. That’s where distributors can play a key role — not just as supply chain intermediaries, but as compliance collaborators.

This article explores how you, as a distributor, can support your manufacturers, reduce risk across your network, and ensure seamless access to the European market.

What Is a UDI Carrier Label and Why Does It Matter?

The UDI Carrier Label includes two parts:

• AIDC: A machine-readable code (usually GS1 DataMatrix) that encodes the UDI.

• HRI: A human-readable interpretation that displays the UDI in plain text.

For Class I devices, this label must include both:

• UDI-DI (Device Identifier – often the GTIN)

• UDI-PI (Production Identifier – batch/lot number, serial number, expiration date, etc.)

Failure to comply can result in:

• Refusal or delay of CE certification

• Product recalls or distribution blocks

• Loss of trust among customers and regulatory authorities
  

Why Distributors Are Crucial in Raising Awareness

1. You’re Often the First Line of Risk Exposure

If a device reaches the market without a proper UDI Carrier Label, the liability doesn't stop with the manufacturer. Distributors who place the product on the EU market may also be scrutinized under Article 14 of the EU MDR for ensuring compliance.

2. You Understand the Market – and the Gaps

Many small manufacturers, particularly those in eyewear, cosmetic devices, wellness products, or niche tech, assume Class I means low-risk and low regulation. That’s often incorrect. They rely on you to interpret market expectations — which now include UDI compliance.

3. You Can Guide and Enable Compliance

Rather than just flagging a problem, you can point your partners to tools, services, or platforms that simplify UDI labeling. This builds loyalty, reduces supply chain risk, and keeps your distribution channels moving.

How Distributors Can Collaborate With Manufacturers

1. Initiate the UDI Conversation

Ask your Class I suppliers direct, clear questions:

• “Have you added UDI-DI and UDI-PI to your product labels yet?”

• “Are you using GS1-compliant codes (GTINs)?”

If the answer is uncertain, that’s your opening to help.

2. Share the EU MDR Deadline

Many smaller manufacturers still don’t realize that 26 May 2025 is their final deadline. This deadline marks the end of transitional provisions for Class I under MDR. Make it visible in your communications.

“To continue selling in the EU after May 2025, you must have compliant UDI labels.”

3. Connect Them With Tools That Simplify UDI

Many manufacturers lack internal regulatory or IT staff. What they need are turnkey solutions, not just directives.

You can recommend platforms like EasyUDI, which allow them to:

• Upload a spreadsheet of their products

• Automatically generate GS1-compliant UDI labels with DataMatrix + HRI

• Customize layouts for different packaging

• Avoid manual formatting.

• Be ready for audits and CE inspections

This moves you from “nagging about compliance” to “enabling peace of mind.”

4. Offer a Value-Add Service (If Applicable)

Some distributors go a step further by:

• Providing label templates or label generation services

• Helping gather and validate GTIN/UDI-PI data

• Partnering with regulatory consultants or compliance tech providers

This adds value to your manufacturer relationships and builds trust.

What If a Manufacturer Refuses to Act?

If you’ve educated and offered help and they still don’t comply, you need to protect your business:

• Document your guidance and communication timelines

• Avoid onboarding new products without UDI Carrier Labels

• Review Article 14 obligations under MDR for distributors

Ultimately, compliance failures upstream can impact your brand, your logistics chain, and your regulatory exposure.

Final Thoughts

Distributors are no longer just delivery pipelines — you’re compliance connectors.

By helping manufacturers understand and meet UDI Carrier Label requirements, you:

• Protect your business from risk

• Strengthen your supply partnerships

• Ensure continued access to the EU market

• Gain a reputation as a knowledgeable, value-adding distributor
  

The MDR UDI deadline is final, fixed, and fast approaching. Start the conversation today — and help your partners label smarter, not later.

Need a simple tool to recommend to your manufacturers? Point them to EasyUDI, and we help them generate compliant UDI labels in minutes without technical setup.