Now our contact lenses are CE marked!

The transition from the old MDD framework to the new and significantly stricter MDR has brought great challenges for the optics industry. But we at Multilens took on the challenge – and now we have crossed the finish line and achieved our long-awaited CE marking!

What is MDR?

MDR stands for Medical Device Regulation, which is the EU's new regulatory framework for medical devices, including eyeglasses and contact lenses. The purpose is to enhance safety and quality by imposing stricter requirements for documentation and control.

Medical devices are classified into different risk classes, from Class I to Class III. Our custom-made contact lenses fall under Class IIa – they are considered medium risk because they come into direct contact with the eye and are used for extended periods.

For such products, a comprehensive technical file is required, including detailed specifications, design and manufacturing information, risk assessments, clinical evaluations, and post-market surveillance.

To market and sell contact lenses in Europe, CE marking is also required.

For Class IIa products like contact lenses, we are reviewed by an independent certification body. Eyeglasses, on the other hand, belong to Class I, where only self-certification is required.

Challenges in the Industry

According to a report from the Swedish National Audit Office (Riksrevisionen), the transition to MDR has been challenging. The number of registered manufacturers of custom-made medical devices in Sweden decreased by approximately 25% between 2018 and 2023. Many companies have simply chosen to cease production because the process of meeting MDR requirements is too extensive.

Due to these challenges, the deadline for transitioning from MDD to MDR has been extended several times. After 2028, all medical devices will fall under MDR, and the sale of products with the old registration will be prohibited.

What Does This Mean for You as a Customer?

With our CE marking and ISO 13485 certification, Multilens has future-proofed its products and can continue to be a stable and reliable partner in specialised optics.

This ensures that our contact lenses meet the highest standards of safety and quality for you as a customer.

Feel free to contact us if you want to know more about our work with MDR or our CE-marked contact lenses!