Team-NB supports the reform in principle; however, in the absence of an impact assessment, Team-NB calls for changes to be evidence-based, realistic, and introduced at a pace the system can absorb. Specifically, NBs want to see any proposed reductions in oversight supported by solid data that justifies the change while demonstrating continued commitment to patient safety. The fee discount proposals should be removed, with proper consideration given instead to changes that genuinely support EU-based SMEs without compromising the principle that NB assessments must be driven by product risk, not company size. To begin with the infrastructure to support the regulation could be focused on with full EUDAMED functionality, and Common Specifications completed first and the publication of the devices which are defined as Well Established Technologies.
Overall – Patient driven, data focused changes
