IVD devices

For in vitro diagnostic devices REGULATION (EC) No 2017/746 (IVDR) will be applied during & after the IVDD/IVDR transition, but deadlines are different from MDR. Just as with the MDR, the introduction of IVDR has led to significant changes in the regulation. Previous risk categories have been transformed, and as a result around 85% of all IVDs will need a Notified Body’s oversight. Accordingly, structural and content compliance of technical documentation as well as performance evaluations are expected to receive much more attention than previously.

Since we are still in the transition period until May 2022, our current projects are mainly aimed at transition opportunities and obtaining certificates under IVDD. Nevertheless, we emphasize the importance of setting up a transition plan and making preparations for the transition in time to all IVD device manufacturers. In cases where there was previously no need to conduct a conformity assessment procedure by a Notified Body, this may present an extraordinary commitment in terms of financial resources and labour capacity.