EDMA, the European Diagnostic Manufacturers Association, welcomes the opportunity to bring forward its position regarding health technology assessment (HTA) applied to in vitro diagnostics (IVDs). EDMA would like to comment on several points of significant importance that are needed to ensure equitable patient access to IVDs and to treatment in Europe. This position delineates EDMA’s vision for the future of HTA for IVDs in the context of Europe’s market access environment.
• In vitro diagnostics play a key role in guiding and enabling decision-making for health and appropriate healthcare, while also contributing to the sustainability of health systems.
• Acknowledging this role, access to IVDs should follow transparent and predictable processes within EU Member States.