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Market access for medical technologies in Spain

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Spain

News and insights

Designation of Benchmark centers of the Spanish National Health System in November 2025

In November 2025, the Ministry of Health approved new Agreements concerning the designation of Benchmark centers, departments, and units of the National Health System (CSURs) for the treatment of rare or complex pathologies. These updates include the decision on new procedures requiring CSUR designation (surgery for complex central airway stenosis), as well as the designation, redesignation, and revocation of CSURs across multiple fields, including in the endocrine, endoscopy, gastrointestinal, nephrology and urology, neurology and neurosurgery, neuromodulation, and neurovascular fields.

Preliminary bill for the Law on Digital Health open for consultation in Spain

On September 22, 2025, the Spanish Ministry of Health launched a prior public consultation on the preliminary bill for the Law on Digital Health, which will regulate the use of big data, digital technologies, and emerging tools in healthcare and research. Among other things, it is expected that the Law will establish conditions for incorporating and financing digital health products such as apps, connected devices, or monitoring systems. Citizens and organizations can submit input via an online form until October 20, 2025.

Draft Order amending the Common Package of Benefits of the Spanish National Health System

On September 5, 2025, the Ministry of Health opened a public consultation on a Draft Ministerial Order to update the Common Package of Benefits of the National Health System. The key planned changes are expected in diagnostic imaging, endocrine, gastrointestinal, in-vitro diagnostics, neurology and neurosurgery, and obstetrics and gynecology fields. Input can be submitted via email until September 26, 2025.