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We’re thrilled to share another key milestone for the company; BAGUERA® C Cervical Disc Prosthesis, and our range of navigated instruments, are now CE Marked under the MDR 2017/745 (Medical Device Regulation) by the notified body TUV Sud.

What is MDR and why does it matter?

The MDR is the set of regulations that control the design, clinical, production and distribution steps of medical devices in Europe entering in force in May 2024. A number of requirements, such as technical files and clinical investigations, must be met in order to be compliant, which in turn ensures a higher level of patient safety.

Spineart is committed to certifying our complete portfolio under the MDR regulation by May 2024. To achieve this goal, we are fully invested in advancing our quality system and clinical studies.

This is the first in a long line of achievements Spineart will ...