Indeed, as supported by the rapporteur MEP Cabezón Ruiz, the clinical evidence needed for assessment of medical devices needs to be improved. In addition, the recently adopted Medical Devices Regulation does not cover aspects of efficacy and cost-effectiveness of medical devices, which have instead to be covered by the HTA Regulation. Finally, medical devices have an important impact on healthcare systems, their patients and budgets, which makes their inclusion in the scope of the future HTA Regulation crucial.

Furthermore, healthcare payers believe that the scope of joint clinical assessment of medical devices should be broadened. All medical devices, and services including medical devices, should be covered. Our statement includes details of several examples of assessments of medical devices that would be excluded from the current proposal, which have proven to have a significant added value.

Find out more in our statement.