We are proud to announce that Eurobio Scientific has successfully obtained CE marking under Regulation (EU) 2017/745 (MDR) for its range of solutions dedicated to cornea banks.
This important milestone confirms our commitment to providing reliable, compliant solutions that support cornea banks throughout the different stages of corneal tissue management.
A complete range for cornea banks
The MDR certification covers our solutions designed for the collection, transportation, storage and deturgescence of corneas:
These solutions are designed to support healthcare professionals and cornea banks in their daily activities while meeting the latest European regulatory requirements.
What does this mean for our customers?
Long-term compliance and confidence
The certificates are valid until 26 July 2031, providing our customers with long-term assurance that these products comply with the applicable European requirements for safety and performance under the MDR.
Continuity of supply
To ensure a smooth transition to the MDR-certified versions, Eurobio Scientific has anticipated stock requirements. This enables the transition to take place seamlessly, without disruption to our customers’ supply.
A milestone that reflects our commitment
Achieving MDR certification is an important step for Eurobio Scientific and for our cornea bank customers. It demonstrates our continued commitment to quality, regulatory compliance and continuity of service in the field of corneal transplantation.
We would like to thank all the teams involved in this achievement and our customers for their continued trust in Eurobio Scientific.
Key Takeaways
- Eurobio Scientific has obtained CE marking under Regulation (EU) 2017/745 for its solutions for cornea banks.
- The certification includes products for collection, transportation, storage, and deturgescence of corneas: CorneaPrep II®, CorneaMax®, and CorneaJet®.
- This MDR certification ensures long-term compliance, valid until July 26, 2031, providing customers with assurance of safety and performance.
- Eurobio Scientific has planned stock requirements to ensure a smooth transition to the certified versions without supply disruption.
- Achieving MDR certification reflects Eurobio Scientific’s commitment to quality, regulatory compliance, and service continuity for cornea banks.
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