ESIP supports the inclusion of a broad scope of medical devices

In view of the forthcoming votes of the European Parliament, the statutory healthcare payers represented by the European Social Insurance Platform (ESIP) advocate for the inclusion of the clinical assessment of medical devices within the scope of the EU Proposal for a Regulation on Health Technology Assessment (HTA).

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.