MTRC has released a White Paper "Clinical evidence requirements for the “Orderly Introduction of Medical Technologies” process in Sweden"

Healthcare in Sweden is managed by 21 regional authorities, each independently deciding on the funding and adoption of medical technologies. While HTA is not formally required for market access of medical devices, assessments by the Dental and Pharmaceutical Benefits Agency (TLV) guide the MTP Council’s recommendations on the orderly introduction of new technologies.

The national framework ("Ordnat Införande") promotes equitable and evidence-based access to innovations. TLV selects high-impact technologies based on inputs from manufacturers, clinicians, and healthcare providers. If promising, TLV may be asked by the MTP Council to perform a formal HTA.

Evaluations are based on clinical and economic data and serve as the foundation for non-binding recommendations to the regions, which retain final decision-making authority.

This report provides an opportunity to learn about the evidence requirements of Sweden's Dental and Pharmaceutical Benefits Agency (TLV) and the Medical Technology Product (MTP) Council in relation to the national process of Orderly Introduction of medical technologies. White Paper outlines the key points and recommendations for the MedTech industry informed by three HTA reports with positive recommendations.

Read more and request a White Paper here.