MDR certification is not easy to obtain and poses challenges to many medical technology companies. Bottlenecks in the supply of medical technology products can be expected. Due to our early MDR certification, measuring and weighing solutions as well as the medical body composition analysis from seca will continue to be available in the future.
The EU is seeking to increase patient safety with the Medical Device Regulation. For us this means that our processes, our hardware and software as well as our services must meet the additional requirements of the MDR. For you this means that the products that you put into operation for the first time must be MDR compliant after the end of the transition period on 27 May 2025.
A Declaration of Conformity (DoC) is issued for every seca product in accordance with the MDR. At seca these are available on the relevant product page under Downloads, or here under Downloads. Since we are currently within the MDR transition period, the MDR certificates will be progressively added until they are all available online by 2023 at the latest.