In-vitro diagnostic tests

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.

On August 5, 2025, the Ministry of Labor, Health, Solidarity, and Families published the 2025 version of the List of Innovative Procedures Outside the Nomenclature (LAHN), which specifies tests funded under the innovative payment scheme for in-vitro diagnostics (RIHN). Tariffs for tests included in the LAHN were expected to decrease by 20% annually from January 1, 2025, except for those with a positive evaluation by the French National Authority for Health (HAS) in defined clinical indications. However, unlike previous edition, the 2025 LAHN does not specify tariffs. It introduces 14 new codes, which duplicate existing generic codes but are restricted to the clinical indications positively assessed by HAS. These new codes will be exempt from the annual tariff reduction.

In August 2025, the Common Catalog of Genetic and Genomic Tests of the National Health System in Spain was updated. Two sections with a total of 140 new genetic tests were introduced: one for bone diseases, including craniofacial anomalies, and another for kidney diseases and urogenital disorders. Furthermore, six new tests were added in pediatric oncohematology. Other changes concerned adult oncohaematology, hereditary metabolic, and mitochondrial diseases.

As of August 2025, the Centre for Assessment of Medical Technology in Örebro region in Sweden is working on health technology assessments in several areas, including in-vitro diagnostics, neuromodulation, and orthopedics.

On August 7, 2025, the UK National Screening Committee (UK NSC) launched a public consultation on its proposed recommendation to continue the in-service evaluation of newborn screening for severe combined immunodeficiency (SCID) in real-world NHS settings. Stakeholders are invited to submit comments by October 27, 2025.