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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Key Updates<\/strong><\/p>\n\n\n\n \u2022 In-house manufacturing by healthcare institutions:<\/strong> 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.<\/p>\n\n\n\n \u2022 Genetic testing and counselling:<\/strong> 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.<\/p>\n\n\n\n \u2022 Registration, marketing, and surveillance:<\/strong> 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.<\/p>\n\n\n\n \u2022 Self-testing products:<\/strong> 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.<\/p>\n\n\n\n \u2022 Market control and traceability:<\/strong> it reinforces the responsibilities of manufacturers, importers, and distributors to maintain robust traceability systems and comply with post-market obligations.<\/p>\n\n\n\n \u2022 European harmonization:<\/strong> by fully implementing the IVDR framework, the decree facilitates adaptation to common EU standards and improves the international competitiveness of companies operating in Spain.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n ClarkeModet recommendations<\/strong><\/p>\n\n\n\n Our Regulatory Services Department advises companies to:<\/p>\n\n\n\n \u2022 Assess the impact of the decree on each product line and internal process. 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.<\/p>\n\n\n\n <\/p>\n","protected":false},"excerpt":{"rendered":" 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 […]<\/p>\n","protected":false},"author":5,"featured_media":18847,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[79],"tags":[],"country":[3],"industry":[100,97],"class_list":["post-18869","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislative-news","country-es","industry-medical-technology","industry-pharma-and-biotechnology"],"acf":[],"yoast_head":"\n
\u2022 Update technical documentation and internal procedures accordingly.
\u2022 Strengthen post-market surveillance and traceability systems.
\u2022 Train technical and regulatory teams on the new requirements.
\u2022 Attend the AEMPS information session on 4 December, dedicated to addressing practical implementation questions.<\/p>\n\n\n\n