The Council of Ministers (Consejo de Ministros) approved the Royal Decree regulating the procedure of selective financing of medical devices in the pharmaceutical benefit for non-hospitalised patients (Real Decreto por el que se regula el procedimiento de financiación selectiva de los productos sanitarios en la prestación farmacéutica para pacientes no hospitalizados) on 10 February 2026. This measure replaces a system established in 1996 and centralises institutional control by subjecting medical devices to the same pricing oversight as medicines.
The regulation mandates that the Interministerial Commission on Medicines Prices (Comisión Interministerial de Precios de los Medicamentos) (CIPM) now determines the reimbursement levels for these products. This shift moves decision-making power to a central body that evaluates clinical utility, comparison with existing alternatives, cost-effectiveness, and budget impact for the National Health System (Sistema Nacional de Salud) (SNS). Inclusion in the reimbursed list is not automatic. The General Directorate for the Common Portfolio of Services of the National Health System and Pharmacy (Dirección General de Cartera Común de Servicios del Sistema Nacional de Salud y Farmacia) (DGCSSNSF) must issue an express resolution for any product to receive public funding.
Eligibility for coverage requires a product to belong to specific categories, such as materials for healing, medicine application devices, or excretion collection systems. To receive public funding, devices must be manufactured in series, carry the CE mark, and require a formal medical prescription. The decree also prohibits any advertising directed at the general public for funded products. Furthermore, manufacturers must provide a formal guarantee of supply once the product enters the market.
The measures take effect on 1 July 2026. A phased implementation will follow, starting with urological and cannulation products in 2026 and concluding with ostomy supplies in 2028. This transition creates a transparent market environment while tightening fiscal control over medical technology expenditure.
Source: Spanish Ministry of Health.
Link: El Gobierno aprueba un Real Decreto para modernizar la financiación de los productos sanitarios en la prestación farmacéutica (The Government approves a Royal Decree to modernise the financing of medical devices in the pharmaceutical benefit).
Date: 10 February 2026
