New framework for in vitro diagnostic medical devices

With the entry into force of Royal Decree 942/2025, of 21 October, which regulates in vitro diagnostic medical devices ("Royal Decree 942/2025"), the adaptation of Spanish law to Regulation (EU) 2017/746 on in vitro diagnostic medical devices ("IVDR”). Although the IVDR is directly applicable, the Royal Decree specifies the competent authority, establishes administrative procedures and language regimes, regulates necessary national figures and repeals – with important transitional regimes – the previous Royal Decree 1662/2000.

Key points of Royal Decree 942/2025

Below we highlight some of the points that we consider most relevant of the Royal Decree 942/2025:

• Prior license: A regime for manufacturers, importers and sterilization activities is regulated, which requires a prior operating license granted by the Spanish Agency for Medicines and Health Products (“AEMPS”), with a maximum validity of five years. The obligation also extends to the operators who manufacture for third parties and those who physically import products into Spain, even if they do not hold the status of “importer” for the purposes of the IVDR. This scheme intends to mirror the applicable regime to medical devices foreseen in Royal Decree 192/2023.

• Manufacture by healthcare centers for their exclusive use (in house): The option of article 5.5 IVDR is displayed. Centers must notify to the AEMPS prior to the start of the activity and cannot subcontract manufacturing. The healthcare centers must accredit their laboratory in accordance with the ISO 15189 standard, and they are prohibited from selling or delivering the products to third parties. The use of these products manufactured by healthcare centers is limited to the centers themselves. The provision of services to the public that includes the use of products manufactured in healthcare facilities will also not be permitted, except upon prescription by a healthcare professional.

• Genetic testing: The chapter on genetic testing requires any healthcare center or professional that performs genetic tests for diagnostic, treatment improvement, predictive, prenatal or healthcare purposes to provide sufficient information on the nature, importance and consequences of the test, and to offer appropriate advice. Express and specific written consent must be obtained, in accordance with Law 14/2007, of 3 July, on Biomedical Research.

• Reference laboratories: The AEMPS is entrusted with the validation of applications from reference laboratories located in Spanish territory, their submission to the Commission, as well as the processing and verification of their requirements.

• Marketing and traceability Register: A marketing Register is created in the AEMPS for economic agents marketing in Spain in vitro diagnostic medical devices. The duties of identification and traceability throughout the supply chain are reinforced, with differentiated requirements for economic agents, healthcare centers and professionals, and points of sale to the public.

• Self-diagnosis products: A prescription is not required for these products, but the retail channel is restricted to pharmacies or their own websites, without intermediaries, without prejudice to the exceptions provided for self-diagnosis computer programs.

• Functional studies: The Royal Decree regulates interventional studies of clinical functioning and other performance studies that entail risks for the subjects of the trial, requiring authorization from the AEMPS and a single and binding opinion from an Ethics Committee for Research with medicines. A presumption of causality is established for damages affecting the subject’s health during the study and up to one year after the completion of treatment, along with minimum coverage through insurance or financial guarantee. Studies with products with CE marking outside their intended purpose are also contemplated.

Royal Decree 942/2025 establishes a comprehensive framework that operationalizes the IVDR in Spain, with an emphasis on security, traceability and transparency. This regulation came into force on October 22, 2025. However, its effective implementation will depend on the full implementation of Eudamed and the marketing Register. Royal Decree 1662/2000 will remain partially in force until these tools are fully operational.

For more information, please contact our Knowledge and Innovation Area specialists.