MDCG 2024-14: Making Sense of Master UDI-DI for Contact Lenses

What’s the Story with MDCG 2024-14?

Let’s face it—medical device regulations can be a labyrinth. But with the release of MDCG 2024-14 on October 26, 2023, the path to compliance for contact lens manufacturers just got a whole lot clearer. This 12-page guidance tackles the nitty-gritty of implementing Master Unique Device Identifiers (Master UDI-DIs), an evolution of the existing UDI system tailored for highly individualised devices. Spoiler alert: it’s all about grouping, simplifying, and making everyone’s life easier (well, almost).

But this isn’t just another piece of bureaucratic paperwork. MDCG 2024-14 builds on the foundational MDCG 2018-1, which first introduced Basic UDI-DIs, and the Commission Delegated Regulation (EU) 2023/2197, which fine-tuned the rules for contact lenses. Together, they provide a roadmap for manufacturers to embrace smarter, leaner compliance practices.

A Bit of Context: The Road to Master UDI-DI

1. MDCG 2018-1: The OG of UDI Systems

Back in 2018, the MDCG laid the groundwork with MDCG 2018-1, which explained how to assign Basic UDI-DIs. These identifiers helped group medical devices with similar purposes, risk classes, and design features. It was a solid start, but for devices like contact lenses—where customisation is the name of the game—it was a bit like trying to fit a square peg in a round hole. Enter the need for Master UDI-DIs.

2. EU Regulation 2023/2197: A Game-Changer for Contact Lenses

Published on October 20, 2023, this regulation officially amended the MDR to introduce Master UDI-DIs for contact lenses. Why? Because contact lenses come in countless configurations (Base Curve, Diameter, Power…you get the idea). A one-size-fits-all approach wasn’t cutting it. The regulation simplifies this mess by grouping lenses with similar clinical parameters under a single Master UDI-DI. And yes, manufacturers, this means fewer sleepless nights over administrative tasks.

What’s new with MDCG 2024-14?

1. Traceability Made Simple

The Master UDI-DI groups contact lenses based on clinically relevant parameters. Think of it as a family tree: one identifier for lenses with the same material, type (e.g., spherical or toric), and design parameters like Base Curve and Diameter.

2. Customised Solutions for Customised Products

• Standard Lenses: These are grouped logically under the same Master UDI-DI.
• Made-to-Order Lenses: For bespoke lenses, the grouping is flexible enough to avoid drowning in minutiae while still ensuring compliance.

3. Labelling That Works for Everyone

Say goodbye to overcomplicated labels. For example, a strip of five contact lenses can carry a single Master UDI-DI, as long as risk management says it’s safe.

4. Better Vigilance and Reporting

If something goes wrong (let’s hope it doesn’t), manufacturers now provide the full UDI (Master UDI-DI + UDI-PI) for faster traceability. A win for regulators and users alike.

What’s the timeline?

• November 9, 2023: The Commission Delegated Regulation 2023/2197 kicks off.
• November 9, 2025: The deadline for compliance. Manufacturers must have Master UDI-DIs for all lenses by this date.

Pro tip: Don’t wait until the last minute. Assigning Master UDI-DIs early gives you time to troubleshoot and refine your processes.

How should Manufacturers prepare?

Here’s the plan:

1. Understand Your Lenses: Identify how to group them under the new Master UDI-DI system (Base Curve, Diameter, and so on).

2. Partner with Issuing Entities: Connect with recognised bodies like GS1 or HIBCC to get your identifiers.

3. Update Your Systems: Make sure your labelling and quality management systems (QMS) are ready for full UDI compliance.

4. Be Vigilance-Ready: Ensure your team can provide complete UDIs when incidents happen. Preparation today saves headaches tomorrow.

FAQs: What You Need to Know

• What’s the difference between Basic UDI-DI and Master UDI-DI? Basic UDI-DI: Groups devices with the same purpose and risk level. Master UDI-DI: Groups individualised devices based on clinical parameters. Think of it as the next layer of specificity.
• What happens to legacy devices? Legacy contact lenses don’t need to be registered in Eudamed unless there’s a vigilance case. If that happens, identifiers like Eudamed ID can be used instead.

Why this matters: beyond compliance

MDCG 2024-14 isn’t just about ticking regulatory boxes. It’s a step toward a more transparent and efficient future for medical device traceability. For manufacturers, it’s an opportunity to streamline operations and reduce regulatory headaches. For regulators and consumers, it’s about safer, more accountable products.

The journey to compliance may seem daunting, but with clear guidance and early preparation, it’s absolutely manageable. So, manufacturers, the ball’s in your court—let’s get started.

CSDmed: Your Partner in the Transition to MDR 2017/745

The European MDR 2017/745 introduces new requirements for medical devices, with more stringent demands on documentation, clinical evaluations, PMS procedures, and many other aspects of regulatory compliance.

At CSDmed, we help clients—whether start-ups, manufacturers, importers, or distributors—overcome the challenges of transitioning to MDR. Our team of experts and specialized consultants will guide you through the entire process, from achieving compliance to final certification.

🔗 Contact us to learn how our team can support you in successfully navigating your MDR transition.