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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

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Key topics

There are two key themes describing market access for medical technologies in Spain:

  • Funding: explicit inclusion of service or implant into the package of benefits provided within the NHS
  • Health technology assessment: HTAs by national and regional organizations

There is no reimbursement, but only funding framework in Spain. Hospitals receive funding through a global budget, although the responsibility for the allocation of hospital budgets is assigned to the health authority of the Autonomous Communities. 

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Funding

One of the key aspects of market access in Spain is the explicit inclusion of service or implant into the package of benefits provided within the NHS. The package of benefits is defined by the Interterritorial Council of the NHS (CISNS), composed of the Health Regional Ministers and the Health Minister of Spain.

The Common Package of Benefits of the National Health System is the set of techniques, technologies or procedures, understood as each of the methods, activities and resources based on scientific knowledge and experimentation, through which health benefits are made effective («BOE» num. 222, 16/09/2006). The Common Package of Benefits is common for all regions of Spain, and each Autonomous Community has its complementary package.

The decision to include new technologies in the package of benefits is made by the Interterritorial Council of the NHS upon the proposals submitted by the Commission of Benefits, Insurance and Financing and the (mandatory) technical advice of the Spanish Network of HTA Agencies (RedETS).

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Health technology assessment

HTAs are performed at the regional level by seven HTA bodies (in Andalusia, Aragon, Basque Country, Canary Islands, Catalonia, Galicia, and Madrid) and at the national level by the Health Institute Carlos III (ISCIII).

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Specifics for IVD tests

There is no specific reimbursement framework for in-vitro diagnostic tests. Most IVD tests are funded using a global budget principle as part of the funding of the labs. 

Genomic and genetic tests that are guaranteed nationwide are included in the Common Catalog of Genetic and Genomic Tests of the NHS.

MTRC has experience with more than 105 projects in Spain

News and insights

“Green Anesthesia” working group established in Spain

In January 2025, the Spanish Minister of Health participated in a meeting to establish the “Green Anesthesia” working group. The group’s goal is to further advance the sustainability of the healthcare system and develop a set of best practices and solutions to achieve “better anesthesia for patients and for the planet”.

Designation of Benchmark centers of the Spanish National Health System in December 2024

In January 2025, it was announced that two Benchmark centers, departments, and units of the Spanish National Health System (CSURs) were designated, and two CSURs were redesignated for previously approved pathologies and procedures in the cardiovascular field.

New tests in the Spanish Catalog of Genetic and Genomic Tests from January 2025

In January 2025, the Common Catalog of Genetic and Genomic Tests of the National Health System was updated in Spain. A new section, “Respiratory medicine,” was added, including 29 tests for multiple respiratory diseases.

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