On 21 October 2025, Spain approved Decree 885/2025, which updates the national framework for in vitro diagnostic medical devices and aligns it with Regulation (EU) 2017/746 (IVDR). This new decree replaces Decree 1662/2000, in force since 2000.
The reform strengthens safety, quality, and transparency in the diagnostic sector, while supporting innovation, competitiveness, and trust among patients and healthcare professionals. It also provides a clearer regulatory environment for manufacturers, distributors, and healthcare institutions.
Key Updates
• In-house manufacturing by healthcare institutions: the decree defines the conditions under which hospitals and clinical laboratories may produce and use their own diagnostic devices, requiring documented justification, full traceability, and compliance with quality standards.
• Genetic testing and counselling: it establishes requirements to ensure that individuals undergoing genetic testing receive appropriate information before the test and professional counselling afterward, including safeguards for data protection and accurate interpretation of results.
• Registration, marketing, and surveillance: it updates the procedures for registration with the Spanish Agency of Medicines and Medical Devices (AEMPS) and strengthens obligations related to market monitoring, vigilance, and post-market performance evaluation.
• Self-testing products: it removes the need for a medical prescription for home-use tests but maintains exclusive distribution through pharmacies and authorized online channels to ensure controlled access.
• Market control and traceability: it reinforces the responsibilities of manufacturers, importers, and distributors to maintain robust traceability systems and comply with post-market obligations.
• European harmonization: by fully implementing the IVDR framework, the decree facilitates adaptation to common EU standards and improves the international competitiveness of companies operating in Spain.
While the decree requires companies to update technical documentation, adapt internal processes, and strengthen post-market surveillance, it also creates an environment of greater regulatory clarity, improved user confidence, and support for technological innovation and personalized diagnostics.
ClarkeModet recommendations
Our Regulatory Services Department advises companies to:
• Assess the impact of the decree on each product line and internal process.
• Update technical documentation and internal procedures accordingly.
• Strengthen post-market surveillance and traceability systems.
• Train technical and regulatory teams on the new requirements.
• Attend the AEMPS information session on 4 December, dedicated to addressing practical implementation questions.
At ClarkeModet, we support healthcare and biotechnology companies in transforming regulatory changes into competitive advantages. We provide comprehensive guidance on compliance, registration, innovation, and the protection of technological assets. The new decree marks a new stage of transparency, safety, and excellence for in vitro diagnostics in Spain, and we help clients navigate this transition with confidence and strategic vision.