In-vitro diagnostic tests

In March 2026, the Galician Agency for Health Technology Assessment (Avalia-t) is working on several HTAs, including in cardiovascular, dermatology, e-health, gastrointestinal, interventional radiology, robotic surgery, in-vitro diagnostics, peripheral vascular, neurology and neurosurgery, neuromodulation, and some other fields.

In January 2026, the Belgian Health Care Knowledge Centre (KCE) published one Health Technology Assessment report on blood-based biomarkers in mild traumatic brain injury and two Health Service Research (HSR) reports addressing chronic pain management and the shift from inpatient to day and ambulatory care.

In February 2026, Health Technology Wales (HTW) accomplished one full appraisal on capsule sponge devices for the detection of Barrett’s esophagus and early-stage esophageal cancer. Additionally, two Med Tech-related Topic Exploration Reports were published in the urology and gynecology fields.

In February 2026, the Swedish Medical Technologies Product (MTP) Council issued two recommendations to Swedish regions within the national framework for the Orderly Introduction of Medical Technologies. The first recommendation concerns MR-guided focused ultrasound (Exablate Prime), which is recommended for patients with severe essential tremor. The second is an interim recommendation advising regions to refrain from introducing diagnostic blood tests for Alzheimer’s disease until the MTP Council has conducted a comprehensive assessment and issued final recommendations.

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.