In-vitro diagnostic tests

On 30 September 2026, Italy published two decrees updating the national Essential Levels of Care (Livelli Essenziali di Assistenza, LEA). The changes combine an approximately €149.5 million expansion of nationally covered services, including new screening programmes, IVD tests and prosthetic aids, with resource-neutral revisions to existing coding, nomenclature and prescribing requirements. Together, the measures expand coverage for selected technologies while updating the conditions governing access to existing services.

In September 2026, the National Institute for Health and Care Excellence (NICE) published a new early-use HealthTech Guidance (HTG) on digital technologies to support home monitoring of vision changes for people with advanced dry age-related macular degeneration. Furthermore, a clinical guideline on suspected sepsis in people aged 16 or over was updated with recommendations on procalcitonin testing.

On September 23, 2026, the National Cancer Strategy Roadmap was released in Finland. It describes the measures, responsibilities, schedules, and conditions for implementing the strategy in practice during the first five-year period (2026-2031). The objectives are to develop person-centered services, reduce the cancer burden through prevention and early detection, and ensure effective and equitable care. Overall, implementation of the National Cancer Strategy is estimated to require approximately €140 million in additional investment.

On September 24, 2026, the Spanish Ministry of Health launched a hearing and public information procedure on a Draft Order updating the rules governing the Health Cohesion Fund (FCS). The update aims to align the Fund’s compensation system with current NHS healthcare needs, with changes expected across endocrine, gastrointestinal, endoscopy, extracorporeal treatments, neurology and neurosurgery, neurovascular, in-vitro diagnostics, and some other areas. Comments may be submitted until October 16, 2026.

On October 1, 2026, the revised EBM (German Uniform Evaluation Standard) catalog for the fourth quarter of 2026 came into force. The EBM catalog is used to reimburse day case and outpatient services under the fee-for-service model. The main changes introduced concern updates to the contents (service legends and preambles of several EBM subchapters) and the introduction of several new EBM codes.

In September 2026, NICE confirmed that rapid MT-RNR1 testing in newborns will be assessed through the National HealthTech Access Programme (NHAP), marking the first time an in vitro diagnostic topic has entered the programme. NHAP applies NICE’s Technology Appraisal methodology to selected health technologies and links positive recommendations to mandatory NHS funding, potentially creating a stronger route to national adoption for selected IVDs.

In September 2026, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system, introducing 114 new codes across medical biochemistry, microbiology, genetics, clinical pharmacology, and immunology. The regular update reflects changes in laboratory practice and ensures that the coding and reimbursement infrastructure continues to accommodate new and evolving diagnostic tests.

On September 10, 2026, the Ministry of Health in France announced nine projects selected for the 2025-2026 Health Economic Research Program (PRME), including four MedTech-related projects concerning nuclear imaging, in vitro diagnostics, treatment of thrombocytopenia, and endoscopic procedures in gastroenterology.

Since June 2026, seven new mini-HTAs have been initiated in Norway, including two MedTech-related assessments in the in vitro diagnostics and cardiovascular areas. These assessments are conducted as part of Norway’s framework for the managed introduction of innovations, known as “New Methods”.

On September 3, 2026, the National Association of Statutory Health Insurance Physicians (KBV) announced an increase in funding for human genetic diagnostic services reimbursed through the EBM catalog. The decision was adopted by the Evaluation Committee following the completion of its annual review of the volume of development in human genetic services.

In September 2026, the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) is working on 23 projects, including several Med Tech-related assessments concerning the diagnosis of endometriosis, newborn screening, and allergy diagnostic tests.

On August 27, 2026, three medical technologies across the in vitro diagnostics and orthopedics fields received final recommendations from the Regional HTA Commission following the appraisal stage within the Lombardy Regional HTA Program.