The first MDR product certificates – more precisely the “EU certificate for the assessment of the technical documentation” – are available for the implants of the A2® short stem system and the 4-motion® knee system. They are valid until the end of 2028 and are available to our customers for download on the ARTIQO website (https://artiqo.de/downloads/).

The European Medical Device Regulation (MDR) has been binding since May 2021 and requires the complete recertification of all products. This includes existing products such as the A2® short stem system, which must meet the increased regulatory requirements of the new regulation. The Council of the European Union extended the transition period again, depending on the risk class of the existing products, and subject to conditions until the end of 2027 or 2028.

ARTIQO GmbH made preparations for the MDR re-certification of its products very early on and has now received the first certificates accordingly early.