MDCG Guidelines On Master UDI-DI Implementation Timelines For Contact Lenses And Spectacles

INTRODUCTION

The Unique Device Identification (UDI) system under the EU Medical Device Regulation (MDR) aims to revolutionize how medical devices are tracked, enhancing patient safety and device traceability. For manufacturers of highly individualized devices like contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles, the Master UDI-DI system has been introduced to improve the efficiency of this process. In this article, we will delve into the Master UDI-DI, its role in medical device traceability, and how manufacturers can prepare for the upcoming regulatory requirements under Eudamed.

WHAT IS THE UDI SYSTEM AND WHY IS IT CRUCIAL UNDER MDCG GUIDELINES?

The Unique Device Identification (UDI) system is a critical part of the European Union’s Medical Device Regulation (MDR). The system requires all medical devices, except custom-made devices, to have a unique identifier that is used throughout their lifecycle. The UDI system is designed to improve device traceability, enhance patient safety, and streamline post-market surveillance.

For most medical devices, the UDI consists of two main components:

Basic UDI-DI: A high-level identifier that groups similar devices.
UDI-DI: A unique identifier assigned to each individual device.

These identifiers are registered in Eudamed, the European database for medical devices, to ensure accurate traceability and efficient regulatory oversight.

WHAT IS THE MASTER UDI-DI IN THE CONTEXT OF MEDICAL DEVICE REGULATION

The Master UDI-DI is a specialized identifier used for highly individualized devices, including contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. These devices are typically sold in many variations, making it difficult to assign a unique identifier for each individual product. The Master UDI-DI groups similar devices under a single identifier based on shared design parameters.

This system streamlines the traceability process by reducing the number of identifiers needed for products that share common characteristics. The Master UDI-DI will be registered in Eudamed, allowing manufacturers, distributors, and regulators to track these devices efficiently.

TIMELINE FOR IMPLEMENTING MASTER UDI-DI AND COMPLIANCE WITH MDCG 2025-7

The MDCG 2025-7 Rev. 1 position paper provides industry‑specific dates for when Master UDI‑DI assignment becomes mandatory for different categories of highly individualized optical devices. These timelines align with relevant Commission Delegated Regulations that amended the MDR.

Date	Milestone	Applies To
26 May 2023	UDI labelling requirement for Class IIa/IIb (contact lenses)	Contact lenses (Class IIa / IIb)
26 May 2025	UDI labelling requirement for Class I (spectacles & lenses)	Spectacle frames, spectacle lenses, ready‑to‑wear reading spectacles
28 May 2026	Mandatory use of UDI/Device registration in EUDAMED	All devices placed on the EU market after this date
9 November 2026	Master UDI‑DI mandatory: Contact lenses	Contact lenses manufactured after this date must use Master UDI‑DI
1 November 2028	Master UDI‑DI mandatory: Spectacles & lenses	Spectacle frames, lenses, and ready‑to‑wear reading spectacles must use Master UDI‑DI

EUDAMED REGISTRATION AND THE UDI/DEVICE MODULE UNDER MDCG GUIDELINES

Eudamed is the European Union’s central database for the registration of medical devices. It contains various modules, including the UDI/Device Registration Module, which will be mandatory for all medical devices starting from 28 May 2026.

The UDI/Device Registration Module is where manufacturers will register their devices, including Master UDI-DI information. Eudamed will serve as a crucial tool for ensuring transparency and traceability for manufacturers, regulators, and other stakeholders in the EU market.

KEY CONSIDERATIONS FOR MANUFACTURERS IN THE UDI SYSTEM UNDER MDR

Manufacturers of contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles must pay close attention to the upcoming regulatory deadlines.

Here are some key points to consider:

Voluntary Implementation: Manufacturers can voluntarily assign the Master UDI-DI before the mandatory deadlines. This proactive step can help manufacturers stay ahead of the regulatory curve and ensure compliance.
Vigilance Reporting: Once the Vigilance and Post-Market Surveillance (PMS) modules of Eudamed become mandatory, manufacturers must use the Master UDI-DI to report vigilance cases. Even if the mandatory assignment deadline for Master UDI-DI has not yet passed, vigilance reporting should be done using the Master UDI-DI if assigned.

Compliance with Eudamed: Manufacturers should ensure that their devices are registered in Eudamed as per the MDR requirements. This ensures that all medical devices are fully traceable and that the regulatory process is transparent.

THE PATH AHEAD FOR UDI IMPLEMENTATION AND EUDAMED REGISTRATION UNDER MDCG

While manufacturers of contact lenses and spectacles have a few years before the mandatory implementation of the Master UDI-DI system, early adoption is strongly encouraged. Master UDI-DI assignment will streamline the regulatory process, provide benefits for manufacturers, and ensure that all devices are fully compliant with the MDR.

By implementing the Master UDI-DI early, manufacturers will be better positioned to comply with the evolving regulatory landscape, take advantage of the features offered by the UDI system, and contribute to improved patient safety and device traceability.

CONCLUSION

The Master UDI-DI system represents a significant leap forward in enhancing the traceability and safety of highly individualized devices under the EU MDR. As contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles manufacturers prepare for upcoming regulatory deadlines, understanding and implementing the Master UDI-DI is crucial. Manufacturers are encouraged to begin assigning Master UDI-DIs before the mandatory implementation dates to ensure a smooth transition and avoid disruptions. With clear timelines, support from Eudamed, and guidance from MDCG, manufacturers can successfully navigate this important change in the EU regulatory framework. For more information, manufacturers can refer to the MDCG guidance documents, including MDCG 2024-14 Rev. 1 for contact lenses and MDCG 2025-8 for spectacles.

HOW MORULAA CAN HELP

Morulaa offers comprehensive medical device regulatory services, including registration, compliance, and distribution setup across multiple markets. We assist manufacturers in navigating EU MDR, IVDR, and CDSCO guidelines, ensuring smooth market entry and compliance. Our services also include post-market surveillance, vigilance reporting, and quality management systems (QMS) to ensure ongoing regulatory adherence. Let Morulaa be your partner in simplifying the complex medical device regulatory landscape.