30 July 2024

The Flemish Interuniversity Council (VLIR), the Flemish Council of Universities of Applied Sciences (Vlaamse Hogescholenraad) and the Conseil des rectrices et recteurs (CRef), draw the attention of all competent authorities on a number of problems regarding the European Medical Device Regulation and the European In Vitro Diagnostics Regulation.

The four main problems concern the impact on patient care, the barriers to (care) innovation within the EU, the challenges for home-developed medical/IVD devices within healthcare institutions and the lack of harmonization between Member States. It is imperative to better tailor legislative and regulatory actions to the potential negative impact on patient care in healthcare institutions and to the innovation capacity of knowledge institutions, research organizations and industry. A revision of the current framework to mitigate these negative effects is urgently needed. Specifically in relation to the implementation of the MDR, a greater role from stakeholders in formulating new/renewed regulations and guidelines is required.

More generally, the argument is made that legislation should take sufficient account of its impact on research, education and innovation. A mandatory assessment mechanism to assess these impacts would help prevent potential barriers for knowledge institutions. We are convinced this is crucial to keep the EU globally competitive in research and innovation.