The article provides an overview of certain aspects of the regulatory framework pertaining to contact lenses, namely, the matters associated with device identification.
Table of content
The Medical Device Coordination Group (MDCG) has published a guidance document dedicated to the implementation of a Master UDI-DI solution for contact lenses. The document describes in detail the relevant regulatory requirements, and also provides additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance. At the same time, it is important to mention that provisions of the guidance are non-binding in their legal nature and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Introduction
In particular, the present guidance focuses on applying a Unique Device Identification (UDI) system to enhance the traceability of medical devices, specifically contact lenses. This UDI system, as outlined in Regulation (EU) 2017/745, requires manufacturers to assign Basic UDI-DIs and UDI-DIs to all devices before they reach the market.
Contact lenses, due to their high level of individualization, require a Master UDI-DI system to effectively streamline tracking and reporting. The guidance explains the assignment process for both standard and made-to-order (MtO) contact lenses.
The regulation prescribes that these identifiers be recorded in Eudamed, the European Database for Medical Devices. Economic operators, particularly manufacturers, must ensure proper device identification and traceability by complying with these rules.
This guidance complements the broader MDR regulations and related MDCG documents.
Terms and Definitions
In order to assist the parties involved with interpreting the relevant regulatory provisions and following the requirements set forth therein, the guidance also provides definitions of the most important terms and concepts used in the context of UDI for contact lenses.
These include the following ones:
- Standard Contact Lenses: mass-produced lenses with limited parameter variations, such as daily disposable lenses.
- Made to Order (MtO) Contact Lenses: custom lenses produced based on specific individual orders, often with unique parameter combinations.
- Contact Lens Design Parameters: clinical measurements used to specify lenses, such as base curve, diameter, and axis.
- Basic UDI-DI: the primary identifier for a device model based on its intended purpose, risk class, and design characteristics.
- Master UDI-DI: a higher-level identifier grouping contact lenses with similar clinical and design parameters (e.g., lenses with the same base curve and diameter).
- UDI-PI (Production Identifier): a component of UDI that tracks the lot number, serial number, and manufacturing date of the device.
As further explained by the MDCG, the Master UDI-DI consolidates data for groups of lenses that share key design attributes, simplifying traceability while remaining compliant with issuing entity standards.
The Master UDI-DI Structure
Under the general rule, the UDI system incorporates Basic UDI-DI and UDI-DI to track individual devices. However, assigning a UDI-DI to every contact lens variant would introduce unnecessary complexity.
Instead, the Master UDI-DI groups lenses based on predefined clinical parameters. This approach reduces redundancy and ensures practical usability for both economic operators and regulatory authorities.
A typical hierarchy includes:
- Basic UDI-DI for material type and design (e.g., spheric, toric, multifocal).
- Master UDI-DI for specific combinations of clinical parameters (e.g., base curve, diameter).
The Master UDI-DI structure ensures that product information is accessible via Eudamed while maintaining differentiation for each lens group.
Assignment of Master UDI-DI
As further explained by the MDCG, the assignment of Master UDI-DI differs for standard and MtO lenses:
Standard Contact Lenses
- Grouped based on a combination of design parameters (e.g., base curve and diameter).
- Each lens design variant (spheric, toric, multifocal) has its unique Basic UDI-DI and corresponding Master UDI-DIs.
Example:
- Basic UDI-DI 1: Material XY, Spheric Design
- Master UDI-DI 1-1: Base Curve X, Diameter A
- Master UDI-DI 1-2: Base Curve Y, Diameter B
Made-to-Order (MtO) Lenses
- Assigned based on broader design categories rather than specific values.
- Example designs include:
- Spherical Design: Base Curve + Diameter + Power
- Toric Design: Base Curve + Diameter + Power + Cylinder + Axis
- Multifocal Design: Base Curve + Diameter + Power + Add Power
The UDI-PI for MtO lenses must include a unique lot or serial number for individual traceability.
Labelling Requirements
According to the guidance, the UDI carrier (barcode or data matrix) must include the Master UDI-DI and be displayed on the product packaging. The format may vary depending on the issuing entity (e.g., GS1, HIBCC).
Labels should ensure both machine-readable (AIDC) and human-readable (HRI) formats for automated and manual verification. The exact placement of the UDI carrier depends on the packaging constraints and the lowest level of packaging used by the end-user.
Conclusion
In summary, the present guidance document issued by the MDCG provides a general overview of the relevant UDI requirements applicable to contact lenses in order to ensure their traceability. The document explains in detail certain specific regulatory requirements to be followed depending on the type of the product in order to ensure their proper identification.
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