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Managed introduction of medical devices

TLV contributes to a national process for managed introduction of new medical devices that is jointly established by all Swedish regional councils. Within this process TLV carries out both health economic evaluations and horizon scanning of medical devices.

The medical technology assignment

By the Swedish government, TLV has been commissioned to carry out health economic evaluations of medical devices. The medical devices should not be included in the pharmaceutical benefits scheme but be subject to procurement by the Swedish regional councils. The medical devices in question for evaluation are typically nominated by the Medical Technology Council (MTP-rådet), jointly representing the Swedish regional councils. Further, TLV collaborates with e.g., clinical experts, the medical technology industry, patients’ organizations, and other relevant authorities.

The regions' collaboration model for medical technology

In January 2020, the 21 Swedish regional councils jointly established a collaboration model for medical technology (samverkansmodell för medicinteknik). Its aim is to achieve a more equal, cost-effective, and appropriate use of medical devices throughout Sweden.

The collaboration model is coordinated and managed by Swedish Association of Local Authorities and Regions, SKR, and thereby also a part of the national system for knowledge management within healthcare. The collaboration model includes a Medical Technology Council (MTP-rådet) that appoints areas of medical technology and groups of medical devices relevant for national collaboration. Moreover, it nominates which medical devices therein to be evaluated by TLV, and subsequently issues recommendations to the regional councils regarding the introduction and use thereof. Furthermore, a Medical Technology Working Group (beredningsgruppen) support the Council by preparing and following up of the regional councils' collaboration activities.

Horizon scanning and health economic evaluations

TLV is an active partner to the Medical Technology Council (MTP-rådet) and the Medical Technology Working Group (beredningsgruppen) within the region councils' collaboration model for medical technology. At present, TLV primarily contributes with:

  • horizon scanning, and
  • health economic evaluations.

In a health economic evaluation, the benefits and costs of a medical device are analyzed and compared to a relevant alternative in respect of Swedish conditions. Health economic evaluations of medical devices optimally results in:

  • improved basis for clinical decisions regarding and procurement of medical devices in the regional councils,
  • greater transparency about the cost-effectiveness and prices of medical devices, and
  • more knowledge-driven and equitable use of medical devices throughout Sweden.

Read more about TLV’s horizon scanning and health economic evaluations of medical devices on the pages below.

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Last updated
1 August 2022
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