In-vitro diagnostic tests

On November 23, 2025, the Norwegian Directorate of Health released an updated version (v.78) of the Norwegian Laboratory Code (NLK) system, along with associated tariffs, for both state and private laboratories. A total of 42 new codes were added in the biochemistry, microbiology, clinical pharmacology, and immunology fields.

On November 17, 2025, the UK National Screening Committee (UK NSC) launched a consultation on the 2025 evidence map relating to population screening for bladder cancer, which is not currently recommended in the UK. The evidence review found no substantial new evidence to change existing recommendations or commissioning further evidence synthesis work. The topic should be reconsidered by the UK NSC in three years. Organizations and the public are invited to submit comments until February 9, 2026.

In October 2025, Health Technology Wales (HTW) accomplished two full appraisals on digital interventions for chronic kidney disease and at-home video monitoring for the diagnosis and management of epilepsy. Additionally, six Med Tech-related Topic Exploration Reports were published in the IVD, e-health, gastrointestinal, and endoscopy fields.

On October 21, 2025, the French National Authority for Health (HAS) issued positive opinions on the inclusion of targeted next-generation sequencing-based panels for patients with multiple myeloma and lung cancer in the NABM Nomenclature for regular reimbursement. Currently, these tests are temporarily reimbursed within the innovative payment scheme (RIHN). These HAS assessments are performed as a part of the RIHN reform and ‘cleaning up’ the List of temporarily covered 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.