MTRC is pleased to present 2025 In-Vitro Diagnostic Tests Market Access Playbook - your annual, refresh‑and‑reuse roadmap to every EU reimbursement deadline.

In July 2025, the National Institute for Health and Care Research (NIHR) in England released seven Med Tech-related assessments in its HTA Journal, which concerned nephrology and urology, pulmonology, gynecology, in-vitro diagnostics and e-Health fields.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Pickaert analysed patient involvement practices in HTA across seven countries (Canada, England, Scotland, France, Germany, Spain, and Italy) to identify lessons for the EU Joint Clinical Assessment (JCA) framework.

As of August 2025, the Scottish Health Technology Group is developing four Med Tech-related HTAs in cardiovascular, diagnostic imaging, neurology and neurosurgery, neuromodulation, and orthopedics areas.

MTRC has released a White Paper titled "Evidence Requirements for IVD Tests in NICE HealthTech Evaluations ". This white paper reviews five assessments of IVD diagnostic technologies conducted under NICE’s previous Diagnostics Assessment Programme (DAP) framework. While terminology and processes have evolved with the introduction of the HealthTech Evaluation Program, these case studies remain highly informative. They offer practical insights into NICE’s evidence expectations and common drivers of recommendation decisions, which continue to shape current evaluation approaches.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Lodhia et al. systematically reviewed staff attitudes, barriers, and enablers to implementing environmentally sustainable practices in operating theatres across eight countries.

On July 17, 2025, the Federal Joint Committee (G-BA) decided that the use of the Oncotype DX Breast Recurrence Score® test as the sole test for deciding for or against adjuvant systemic chemotherapy will be reimbursed for patients with primary hormone receptor-positive, HER2-negative breast cancer involving one to three lymph nodes. Previously, reimbursement was limited to patients without lymph node involvement.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, Akpinar et al. systematically reviewed quality assessment instruments for health economic evaluations, focusing on their suitability for medical devices.

In July 2025, the Dutch Organization for Health Research and Development (ZonMw) awarded twelve projects under the 2026 round of the Efficiency Research program concerning e-health, diagnostic imaging, gastrointestinal, endoscopy, orthopedics, gynecology, pulmonology, and cardiology fields.

The French National Authority for Health (HAS) released new recommendations on the registration of medical devices and medical aids in the List of Reimbursable Products and Services (LPPR) following the July 2025 meetings of the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Four favourable opinions were issued concerning add-on reimbursement for medical devices in the orthopedics and ENT fields.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Carbonneil et al. analyzed the key stages of health technologies reimbursement in France, outlining the process from regulatory authorization to health technology assessment and final reimbursement decision.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Willemsen et al. analyzed the Dutch response to the EU Health Technology Assessment Regulation (HTAR), which took effect in January 2025.