Order updating the regulation of point-of-care tests released in France

On February 7, 2026, the Ministry of Health, Family, Autonomy and People with Disability published an Order in the Official Journal of the French Republic amending the 2014 regulations on conditions of sampling and performing medical biology tests outside of a medical biology laboratory.

The update follows the French National Authority for Health's (HAS) corresponding opinion, released on December 19, 2025, and aims to improve access to urgent diagnostics in areas where laboratory coverage may be insufficient.

The new Order amends the Order of August 13, 2014, which established the categories of healthcare professionals authorized to perform point-of-care testing and defined the locations where such testing may be performed. The new regulation expands the list of locations eligible for performing the analytical phase of testing outside of a medical biology laboratory to the following positions:

• Medical offices;
• Multidisciplinary and local health centers;
• Maternal and infant protection services;
• Nursing homes (EHPAD);
• Free information, screening, and diagnosis centers;
• Sexual health centers;
• Medical vehicles (during medical transportation).

Unlike the 2014 Order, the new February 2026 regulation also provides an explicit list of tests which can be performed as “delocalized” (biologie délocalisée) in connection to eligible locations. For instance, medical offices are explicitly eligible for testing for Troponin (I or T), INR/D-dimers (coagulation), HbA1c, and Lipase.

The new regulation mandates a comprehensive convention between these remote sites and a responsible medical laboratory. The update also imposes quality assurance mechanisms, such as authorization of a remote site by the Regional Health Agencies (ARS) based on territorial criteria, accreditation requirements, etc.

See more details in French here and here.

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