In-vitro diagnostic tests

In January 2026, the UK National Screening Committee (UK NSC) published details of EquipoISE, a new framework to help evaluate whether multiple additional rare conditions could be added to the UK Newborn Blood Spot (NBS) Screening Programme. EquipoISE is designed as a rolling multi-condition in-service evaluation that works within the existing NHS screening pathway to answer key questions about test performance, clinical outcomes, and feasibility in real-world NHS settings.

On December 31, 2025, the Ministry of Health, Family, Autonomy, and People with Disabilities published a Decree, amending the conditions of temporary coverage for innovative IVD tests via the RIHN framework (included in the List of Innovative Procedures Outside the Nomenclature, LAHN). Changes include extending the maximum duration of transitional coverage from five to nine years and lowering the annual tariff reductions from 20% to 10%. The LAHN 2026 was also released, reflecting the changes introduced by a Decree.

In December 2025, the National Institute for Health and Care Research (NIHR) in England released three Med Tech-related assessments in its HTA Journal, which concerned endoscopic treatments for obesity, whole-genome sequencing for rare diseases in newborn screening, and a tele-ophthalmology-enabled and artificial intelligence-ready referral pathway for community optometry referrals of retinal disease.

On December 3, 2025, the Swiss Federal Office of Public Health announced amendments to the Healthcare Benefit Ordinance, including its Annex 3 (the List of Analysis). The modifications include the creation of a new code for Dermatophytes testing by nucleic acid amplification.

On December 3, 2025, the Swiss Federal Office of Public Health published updates to the Healthcare Benefit Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The changes will take effect on January 1, 2026, and relate to prophylactic vaccinations, cost containment measures, and other matters. The updates are also implemented in KLV Annexes, including the List of explicitly evaluated services (Annex 1), the outpatient-before-inpatient mandate (Annex 1a), the List of Medical Aids (Annex 2, MiGeL), and the List of Analyses (Annex 3, AL).

In November 2025, the National Institute for Health and Care Research (NIHR) in England released four Med Tech-related assessments in its HTA Journal, which concerned procalcitonin evaluation of antibiotic use in COVID-19 hospitalized patients, comparison of the knee arthroplasty versus joint distraction for osteoarthritis, comparison of surgical approaches for mitral valve repair, as well as comparison of sample types for diagnostics of infected diabetic foot ulcers.

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.