Spain publishes new regulation for in vitro diagnostic medical devices: key points of Royal Decree 942/2025

Introduction

Spanish Royal Decree 942/2025 regulating in vitro diagnostic medical devices came into force on October 24, 2025 (Royal Decree 942/2025). This new piece of regulation establishes the national legal framework applicable to in vitro diagnostic (IVD) medical devices, aligning Spanish law with Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (Regulation (EU) 2017/746). Royal Decree 942/2025 replaces Royal Decree 1662/2000 and aims to guarantee the safety, traceability and quality of these products, while fostering innovation and transparency in the sector.

 

European context

At European level, it was deemed necessary to establish a new regulatory framework for in vitro diagnostic medical devices that is robust, transparent, predictable and sustainable, ensuring the highest level of safety and health protection for patients and users, while promoting innovation and the interests of small and medium-sized enterprises operating in this sector. To this end, it was approved Regulation (EU) 2017/746. The publication of Royal Decree 942/2025 responds to the need to harmonize national regulations with the European Regulation (EU) 2017/746, which introduces stricter requirements for conformity assessment, risk classification, traceability, as well as strengthening the supervision of notified bodies and the designation of reference laboratories.

 

Main new features of the Royal Decree

The Royal Decree 942/2025 regulates various aspects left to the discretion of each Member State, in particular:

• Competent authority: The Spanish Agency for Medicines and Health Products (AEMPS) assume overall supervision, including product classification, control, supervision and monitoring of all IVD products manufactured, imported or marketed in Spain.
  
  
• Licensing and Manufacturing: Prior licensing is required for facilities that manufacture, import or sterilise IVD products. A specific regime is established for healthcare centers manufacturing IVD products for exclusive internal use, provided prior notification is made to AEMPS.
  
  
• Genetic testing: Genetic testing must be conducted exclusively for medical purposes, always with informed consent and specialist advice, in accordance with Law 14/2007 on Biomedical Research.
  
  
• Marketing register: a national register has been created to ensure the traceability and control of products distributed in Spain.
  
  
• Performance studies: Ethical and procedural requirements are established for interventional studies, including a favourable opinion from the Ethics Committee for Research with Medicines (CEIm) and mandatory insurance coverage.
  
  
• Surveillance system: The process for reporting serious incidents and adopting corrective actions is reinforced, with coordination between the AEMPS and the autonomous regions.
  
  
• Control and protection measures: Immediate actions are regulated where health risk is foreseen, including product withdrawal and notification to the European Commission.

 

Impact on the sector

The regulation introduces greater requirements for traceability, documentation and control, which implies significant adjustments for manufacturers, importers, distributors and healthcare centres. Although it entails an increase in administrative burdens, it also provides legal certainty and regulatory consistency, promoting competitiveness and confidence in the market.

 

Conclusion

Royal Decree 942/2025 marks a milestone in the national regulation of in vitro diagnostic medical devices, consolidating adaptation to the European framework and strengthening public health protection. Companies in the sector must review their procedures to ensure compliance with the new obligations, particularly in terms of licensing, registration and surveillance.