Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
White Paper: Clinical evidence requirements for the “Orderly Introduction of Medical Technologies” process in Sweden
Get insights from MTRC White Papers to advance your understanding on the evidence requirements guiding the national adoption of medical technologies in Sweden
Recent news and posts
February 2026 recommendations from the Swedish Medical Technologies Product Council
The national framework for the Orderly Introduction of Medical Technologies is a staged process that includes horizon scanning, selection of products for evaluation, the MTP Council’s decision to develop recommendations, health economic evaluation by the Dental and Pharmaceutical Benefits Agency (TLV), and the issuance of recommendations by the MTP Council to Swedish regions. In some cases, the MTP Council may issue temporary recommendations advising regions to refrain from introducing a technology until the evaluation is completed and final recommendations are issued.
On February 20, 2026, the MTP Council issued a favorable recommendation to regions regarding the use of magnetic resonance imaging-guided focused ultrasound (MRgFUS) for the treatment of patients with essential tremor:
- Treatment with MRgFUS (Exablate Prime) should be offered to patients with severe essential tremor who have insufficient effect from pharmacological treatment and who are not candidates for deep brain stimulation (DBS).
- National collaboration should be established to optimize the number of treatments performed per equipment unit and to ensure patients’ equal access to treatment.
On February 18, 2026, the MTP Council issued an interim recommendation advising regions to refrain from the broad implementation of blood tests for the diagnosis of Alzheimer’s disease and to limit their use to specialist healthcare settings and clinical studies until sufficient evidence is available for a comprehensive assessment and final recommendation.
The tests in question are performed directly from a blood sample, in which the analysis identifies biomarkers reflecting accumulations of disease-causing amyloid-beta in plaques and a hyperphosphorylated variant, p-tau, which accumulates inside nerve cells. Some tests also analyze combinations of different biomarkers.
See more details in Swedish here and here.
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