In-vitro diagnostic tests

In October 2025, the National Institute for Health and Care Research (NIHR) in England released four Med Tech-related assessments in its HTA Journal, which concerned tumor profiling tests in early breast cancer, remote monitoring of heart failure in people with cardiac implantable electronic devices, microstructural scaffolds in symptomatic defects of the knee, as well as rapid tests for antifungal stewardship in the ICU.

On October 20, 2025, Genomic Medicine Sweden (GMS) announced the launch of five strategic development projects aimed at extending access to advanced diagnostics nationwide. The projects will focus on updating national GMS gene panel (big NGS panel for solid tumors), liquid biopsies, cell-free tumor DNA (ctDNA) for diagnosis and follow-up of metastatic breast cancer, gene panels for hepatopancreatobiliary (HPB) cancer, and improving diagnosis of sarcoma.

On October 16, 2025, the Federal Joint Committee (G-BA) launched the consultation procedure on a risk-adapted prostate-specific antigen (PSA) and MRI-based screening for the early detection of prostate cancer, in line with §135 SGB V (G-BA Directive on Ambulatory Care Methods; conceptually new diagnostic and therapeutic methods). Public comments may be submitted electronically by November 23, 2025.

As of October 2025, the Scottish Health Technologies Group is working on health technology assessments in several areas, including diagnostic imaging, e-health, endoscopy, ENT, in-vitro diagnostics, neurology, orthopedics, and robotic surgery procedures.

On September 23, 2025, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system, along with associated tariffs, for both state and private laboratories. A total of 35 new codes were added in the biochemistry, microbiology, clinical pharmacology, and immunology fields.

In September 2025, the National Institute for Health and Care Research (NIHR) in England released four Med Tech-related assessments in its HTA Journal, which concerned pulmonology, in-vitro diagnostics, cardiology, and dermatology fields.

As of September 2025, the Swedish Agency for Health Technology Assessment and Assessment of Social Services is working on health technology assessments in several areas, including in-vitro diagnostics, e-health, and gynecology procedures.

In the third quarter of 2025, the Agency for Health Technology Assessment and Tariff System (AOTMiT) initiated six Med Tech-related assessments in diagnostic imaging, endocrine, in-vitro diagnostics, nephrology and urology, and robotic surgery fields.

On September 5, 2025, the Ministry of Health opened a public consultation on a Draft Ministerial Order to update the Common Package of Benefits of the National Health System. The key planned changes are expected in diagnostic imaging, endocrine, gastrointestinal, in-vitro diagnostics, neurology and neurosurgery, and obstetrics and gynecology fields. Input can be submitted via email until September 26, 2025.

In September 2025, the Belgian National Institute for Health and Disability Insurance (INAMI/RIZIV) updated the list of reimbursable companion diagnostics. A new clinical indication, urothelial carcinoma, was introduced, with two new predictive biomarker tests included in the List.

In August 2025, the Dutch Organization for Health Research and Development (ZonMw) awarded seventeen projects under the subsidy round “Preparatory implementation activities Round 1” of the Appropriate Care Framework program. Awarded projects include e-health, men’s health, in-vitro diagnostic, and other fields.

In June-July 2025, Health Technology Wales (HTW) accomplished one full appraisal on implantable tibial neuromodulation devices for urinary incontinence. In addition, seven Med Tech-related Topic Exploration Reports were published in the e-health, diagnostic imaging, in-vitro diagnostics, neurology, and radiotherapy fields.