Spineart is thrilled to share a key milestone for the company: the secured cervical and lumbar cages, SCARLET® AC-T and SCARLET® AL-T, and our Posterior Lumbar JULIET®Ti cages are now CE Marked under the MDR 2017/745 (Medical Device Regulation) by the notified body TUV Sud.
This is a step further towards our commitment to certify 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.
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 effect 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.