Barcelona, January 2025.

Dear partner,

We would like to share with you that we have made a significant effort to obtain the CE MDR certification (EU) 2017/745 (the new European Medical Devices Regulation), and at SIBELMED, we are still moving forward with determination to complete the process.

A large part of our products received the new certification in 2024 and the rest are in the transition process, with certification expected to be finalized soon. Throughout this challenging adaptation to the MDR, we have faced various hurdles, from updating our design and clinical evaluation processes to implementing the strict quality standards required. This major achievement has been possible thanks to a rigorous process of audits and continuous review of our procedures, representing an important milestone for SIBELMED.

The MDR certification not only guarantees the safety and quality of our products but also reinforces SIBELMED as a trusted leader both nationally and internationally.

This is a major accomplishment that few manufacturers have achieved due to the obstacles involved. All of this has been made possible by your trust.

We continue to move forward, growing together.

The SIBELMED team.

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