There are proposals to update the MDR and IVDR – why are these important?

The key objectives of the new proposals by the EU Commission might be summarized as follows:
Simplify and streamline the regulatory framework to reduce administrative burdens and costs without impairing patient safety.
Enhance predictability and efficiency of certification processes while maintaining high safety standards.
Reduce financial costs for SMEs to ensure their competitiveness
Ensure device availability, including for orphan disease applications and for new technologies, the so-called “breakthrough devices”