MDR CE certificate for Inreda AP®

On the 16th of December 2023, Inreda Diabetic BV received a CE certificate for the Inreda AP® as evidence that it complies with the new European regulation for medical devices, which is the MDR (Medical Device Regulation). We are very proud of this achievement!

From the old to the new legislation

The Inreda AP® had already been certified according to the old European directive MDD (Medical Device Directive) since February 2020, and now complies with the new MDR regulation. In many ways, the MDR is more demanding than the old legislation. One of the major changes is a greater focus on clinical evidence. Furthermore, a central European database “Eudamed” is being developed in which medical devices will be registered. Thus, in the future, patients and authorities will have better access to up-to-date information regarding the safety and effectiveness of medical devices. Manufacturers of medical devices who market their product in Europe are required to certify their devices according to the MDR.

What does this mean for Inreda AP® users?

By obtaining MDR certification, the Inreda AP® complies with the new European regulation. This will allow Inreda Diabetic BV to continue with the development and focus on long term availability of the AP for people with diabetes and improve their quality of life