MDCG Guideline on UDI Assignments  For Spectacle Lenses and Ready Readers

The MDCG (Medical Device Coordination Group) has released a position paper on UDI assignment to assist the manufacturers of spectacle lenses and ready readers about the obligations under the EU Medical Device Regulations (EU MDR) 2017/745. It also has the details to be considered while assigning an UDI (Unique Device Identification) to these devices. In addition, this position paper defines the data elements for BASIC UDI and UDI-DI groupings for spectacle lenses and ready readers. The UDI assignments are expected to ensure uniformity in identification of devices manufactured by different entities and proportionate entries in the EUDAMED UDI Module.

The legal basis for the UDI under the EU MDR is defined in Articles 10 (7) and Article 27, whereas the registration obligations are defined in 29 and 31. The UDI system is expected to improve the device identification and traceability of devices and effective post-market safety obligations. The regulations also define the changes that require for assignment of a new UDI - DI (Unique Device Identification – Device Identifier).

The UDI for spectacle lenses shall include the basic UDI-DI level, UDI-DI level and UDI-PI (Production Identifier) level. The Basic UDI-DI shall include Commercial Indexes, Options, Design and Lens Material. The commercial index shall include the lens index describing the thickness of lens and available options of lens such as, polarized, photochromic, etc. The design aspects of the lens such as, single vision, bi-focal or multi-focal or variation power lenses and whether the lens is made up of either mineral or organic material shall be considered. The UDI-DI level shall include the commercial name of the spectacle lenses in addition to the components covered under BASIC UDI-DI. The UDI-PI shall include the device production information, but not the customer’s prescription parameter of the spectacles.

The UDI assignment of the ready readers shall also include the basic UDI-DI level, UDI-DI level and UDI-PI level for identification of different variants of ready readers. The BASIC UDI-DI level assignment shall include a combination of the attributes - Frame construction, Frame material and Len material. The frame construction shall include, the details of the rim, whether it is full or half or rimless or any other type. The frame material shall include the details of the Material of Construction (MoC) of the frame such as, metal or plastic or any other material. The lens material shall include details on whether it is made up of mineral or organic material.

The UDI-DI level assignment is a combination of attributes such as, commercial name, colour, Lens (A dimension) and Nose width (DBL), material and power of the lens. The UDI-PI, similar to any other medical device is an alphanumeric code, to identify the unit of the production lot. Like the spectacle lenses, the UDI-PI of ready readers shall include the device production information, but not the customer’s prescription parameter of the ready readers.

UDI Assignments for spectacle lenses and Ready readers

UDI Level

Spectacle Lenses

Ready Readers

UDI BASIC_DI Level

Commercial Indexes

The number describing the thickness of the lens

Frame Construction

Full rim, half rim, rimless and other types

Options

Photochromic, polarized or clear

Frame Material

Metal, plastic, mixed

Design

Single vision, Bi-focal, multifocal, variation power lens, etc

Lens Material

Mineral or Organic

Lens Material

Mineral or Organic

 

 

UDI DI LEVEL

Commercial Indexes

The number describing thickness of the lens

Commercial Name

Brand Name

Options

Photochromic, polarized or clear

Colour

Green

Design

Single vision, Bi-focal, multifocal, variation power lens

Lens Width

A dimension

Lens Material

Mineral Organic

Nose Width

DBL

Commercial Name

Brand Name

Power

Specified in Diopters

 

 

Lens material

Mineral or organic

UDI PI LEVEL

Identify the unit of device production

Alphanumeric code

Identify the unit of device production

Alphanumeric code

As there is an increasing concern for patient safety and efficient supply chain management, an UDI assignment is a key element for device identification and traceability. To avoid Regulatory recalls, manufacturers must adhere to UDI requirements and seek an expert’s advice to achieve seamless UDI compliance. Stay informed. Stay compliant.