Master UDI-DI for Spectacle Frames: What Opticians Need to Know Today

Introduction:

On November 21, 2025, the MDCG 2025-8 released its guidance on implementing the Master UDI-DI for spectacle frames, lenses, and ready-to-wear reading glasses. This regulatory update, stemming from the EU MDR (Regulation 2017/745), is a game-changer for opticians. Starting now, professionals must prepare for its impact on traceability and Eudamed registration. Here’s what you need to know.

Why Does Master UDI-DI Matter?

The Master UDI-DI is a unique identifier designed to group highly individualized medical devices, such as spectacle frames. It enhances traceability and transparency by linking each product to specific design parameters (material, frame size, etc.). Unlike the Basic UDI-DI, which identifies a product family, the Master UDI-DI provides more granular details, making data management in Eudamed more efficient.

Example: For a full-rim plastic frame with a 52 mm lens size, the Master UDI-DI will combine:

• Frame type (full-rim, half-rim, etc.)

• Material (plastic, metal, etc.)

• Frame size (e.g., 52 mm)

What’s Changing for Opticians?

1. Regulatory Requirement: As of November 1, 2028, assigning a Master UDI-DI will be mandatory for all frames and lenses. Products manufactured before this date are exempt, but opticians should start preparing now.

2. Impact on Eudamed: Each Master UDI-DI must be registered in the Eudamed database. This requires a review of registration processes and data management systems.

3. A Competitive Edge: Early adoption of the Master UDI-DI can enhance compliance and credibility with customers and regulators.

How to Prepare?

• Internal Audit: Ensure your frames and lenses are classified according to Master UDI-DI parameters.

• Training: Educate your team on the new requirements.

• Software Solutions: Use specialized SaaS tools to automate UDI-DI generation and management (e.g., Made In Tracker).

• Consulting: Work with regulatory experts to secure your transition.

Solutions Are Available

Platforms like MadeInTracker offer SaaS solutions to simplify UDI-DI management and Eudamed registration. These tools help:

• Automatically generate identifiers.

• Centralize product data.

• Streamline Eudamed submissions.

Conclusion

The Master UDI-DI is not just a regulatory hurdle—it’s an opportunity to modernize your data management and build trust with customers. Act now to avoid compliance risks.