In-vitro diagnostic tests

On June 10, 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 July 1, 2025, and relate to colorectal cancer screening with the increase in the number of reimbursed colonoscopies, cancer treatment, men’s health, medical aids, and other medical services.

On June 5, 2025, the French National Authority for Health (HAS) published its favorable opinion on the coverage of AI-assisted digitalized urine cytology using VisioCyt Bladder, an in-vitro diagnostic medical device, under the renewed Repository of Innovative Procedures outside the Nomenclature of Biology and Anatomocytopathology (RIHN) 2.0.

In May 2025, Health Technology Wales (HTW) accomplished one full appraisal on advanced electrosurgical bipolar vessel sealing systems during hysterectomy. One Med Tech-related Topic Exploration Report was published on AMBLor for identifying low-risk non-ulcerated early-stage cutaneous melanomas.

On May 23, 2025, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system and associated tariffs to be implemented no later than September 1, 2025. A total of 55 new codes were added in the biochemistry, microbiology, clinical pharmacology, and immunology fields.

In May 2025, the National Institute for Health and Care Research (NIHR) in England released five Med Tech-related assessments in its HTA Journal, which concerned the evaluation of high-flow nasal cannula therapy in pediatric critical care, assessment of IVD tests for guidance of antibiotic treatment, and the results of the research on clinical and cost-effectiveness of first-trimester ultrasound screening for fetal anomalies. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS, and informs NICE guidance.

On May 27, 2025, a new version of the Nomenclature of Medical Biology Procedures (NABM 97) was released. Changes concerned the introduction of a new code and modifications to the descriptions and wording of several existing codes.

On May 12, 2025, the updated version of the Finnish Laboratory Tests Nomenclature was published by the Finnish Institute for Health and Welfare (THL) to come into force on June 1, 2025. Twenty-one new codes were introduced.

On May 13, 2025, the Common Package of Benefits of the Spanish National Health System (NHS) was amended. The med tech-related updates mostly concerned in-vitro diagnostics, gastrointestinal, e-Health, cardiovascular, ENT, ophthalmology, oral health, and neurology fields.

In April 2025, the French National Authority for Health (HAS) opened the application period for including medical procedures and in-vitro diagnostic tests in its 2026 evaluation working program. The application deadline is July 8, 2025.

On May 6, 2025, NHS England issued an updated version of the National Genomic Test Directory for 2025/26, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. One new code (test-indication combination) was introduced in the Test Directory for cancer, and one for rare and inherited diseases.

In March-April 2025, Health Technology Wales (HTW) accomplished one full appraisal of permanent implant brachytherapy devices for unresectable pancreatic cancer. Five Med Tech-related Topic Exploration Reports were published (on superior rectal artery embolization, glucose monitoring systems in neonates, gender-affirming surgery, telemetric intracranial pressure monitoring, tumor-profiling tests to guide bisphosphonate treatment in cancer).

On May 01, 2025, the Dutch Healthcare Authority (NZa) published the first release of the 2026 DRG package (RZ26a). Three new procedure codes, seven new supplementary payments (OZPs), one new diagnosis code, and two new DRGs will be implemented across in-vitro diagnostics, obstetrics and gynecology, neurology and neurosurgery, cardiovascular and other technology groups.