In-vitro diagnostic tests

A new version of the Nomenclature of Medical Biology Procedures (NABM 102), effective from March 3, 2026, was published in France. Changes include the introduction of one new code and the deletion and modification of several codes.

On February 7, 2026, the Ministry of Health, Family, Autonomy and People with Disability released an update of the 2014 regulations on conditions of performing IVD tests outside the medical biology laboratory. The new regulation expands the list of locations eligible for point-of-care testing (POCT) and provides an explicit list of tests that can be performed as POCT, and links them to eligible locations. It also introduces a quality assurance framework, accreditation requirements, and mandates that comprehensive conventions be concluded between the remote sites providing POCT and the responsible laboratories.

On February 4, 2026, the Department of Health and Social Care and NHS England published the National Cancer Plan for England, setting out a decade-long, technology-enabled transformation of cancer services, with substantial commitments to diagnostics, AI, genomics, robotic surgery, digital tools, and innovation-driven care pathways. The key ambition is that, by 2035, three out of four people diagnosed with cancer will be cancer-free, or living well with cancer after five years.

In January 2026, nine new topics were added to the Implementation Agenda of the Care Evaluation and Appropriate Use (ZE&GG) program, requiring healthcare providers to implement these evidence-based practices in daily care and to demonstrate results within two years. The topics concerned the in-vitro diagnostic, gastrointestinal, and ENT fields. Additionally, 16 topics were removed from the agenda, as most had been sufficiently implemented and others were no longer relevant.

In early February 2026, the French National Authority for Health (HAS) opened the call for applications for the evaluation of medical procedures and in-vitro diagnostic (IVD) tests to be included in its 2027 working program. The deadline for submission is May 4, 2026.

In January 2026, the Dutch Organization for Health Research and Development (ZonMw) awarded fourteen projects under the “Implementation round 3” of the Efficiency Research program, including the MedTech projects in e-health, gastrointestinal, oncology, neurosurgery, IVD, and cardiovascular fields.

On January 13, 2026, a new version of the Nomenclature of Medical Biology Procedures (NABM 101) was published in France. A new chapter for constitutional genetics was introduced, including two new codes.

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).