How to assign Master UDI-DIs to contact lenses: A new regulation update
If you are a manufacturer of contact lenses selling in the European Union, you may be familiar with the Unique Device Identification (UDI) system that is required by the European Union. The UDI system is a way of identifying and tracing medical devices throughout their lifecycle. It consists of two parts:
- a device identifier (UDI-DI) and
- a production identifier (UDI-PI).
The UDI-DI is a code that identifies the specific model and manufacturer of a device, while the UDI-PI is a code that identifies the production information, such as lot number and expiration date.
The UDI system is designed to facilitate rigorous traceability, bolstering post-market surveillance efforts aimed at improving medical device quality and ensuring patient safety. With regard to Regulation (EU) 2017/745 Medical Device Regulation [MDR], every medical device needs to have a UDI. However, in the case of contact lenses, it poses some challenges as contact lenses hav many variants due to different clinical parameters, such as power, base curve, and diameter.
According to the current regulation [MDR], each variant of contact lenses needs to have its own UDI-DI. This means that there are too many UDI-DIs to be assigned and managed by manufacturers and stored in the European database on medical devices (Eudamed).
To address this issue, the European Commission on 20 October 2023 published an amendment which introduces a new concept of Master UDI-DI for contact lenses. A Master UDI-DI is a code that groups contact lenses that have the same combination of design parameters, such as base curve and diameter. This way, similar contact lenses can share the same UDI-DI, reducing the number of UDI-DIs and simplifying the identification and traceability process.
The new regulation will apply from 9 November 2025, but manufacturers can use it earlier if they wish. To comply with the new regulation, manufacturers need to implement some changes in their internal systems and adapt their technologies for printing and scanning UDI carriers.
Our experts recommend that manufacturers initiate the transition process by following these steps:
- Review your current portfolio of contact lenses and identify the design parameters that differentiate them.
- Assign a Master UDI-DI to each group of contact lenses that have the same combination of design parameters.
- Update your product labels and packaging with the Master UDI-DIs and UDI-PIs. You can use different methods to display the UDI, such as barcodes, QR codes, or RFID tags.
- Upload your Master UDI-DIs and other relevant information to Eudamed. Check the status of EUDAMED
- Train your staff and educate your customers on how to use the Master UDI-DIs for identification and traceability purposes.
By following these steps, you can ensure that your contact lenses comply with the new regulation and benefit from the advantages of the UDI system. The Master UDI-DI is a solution that will make your products more transparent, traceable, and safe for patients.
Our Regulatory Consultants at Med-Di-Dia can support you with this transition by
- Reviewing your Technical Documentation
- Assisting you with grouping your products
- Updating your information on the relevant database
- Representing you in the EU as an Authorised Representative [EU AR] or Person Responsible for Regulatory Compliance [PRRC]
- Support in creating labels and other required documents
Contact our experts via mdd@mddltd.com or filling out this contact form - https://mailchi.mp/a3744c8d52c0/eumdr
