In Vitro Diagnostics (IVD)

The SEIV In Vitro Diagnostics (IVD) Sector was established with the aim of highlighting the specific needs and challenges of the in vitro diagnostics field, which differ significantly from the broader medical technology sector. In vitro diagnostics are a key pillar of modern healthcare systems, supporting diagnosis, prevention, treatment selection, and patient monitoring.

The establishment of the Sector responds to critical developments affecting the field, such as the enhanced regulatory framework of the IVDR, the specific operational models of the market (such as cost-per-test models), as well as challenges in the pricing and reimbursement of tests based on in vitro diagnostics.

At the same time, the decisive role of in vitro diagnostics in public health is highlighted, particularly in the design and implementation of screening programs, as well as the importance of data utilization, interoperability, and adequate laboratory infrastructure.

The IVD Sector operates complementarily to the horizontal Sectors of SEIV and aims to:

• formulate well-documented positions and interventions
• develop coherent policy proposals addressed to the relevant institutional authorities
• support the proper functioning of the market and innovation in the field of in vitro diagnostics
• strengthen the institutional representation of the sector at national and European level