# European Union innovation needs regulatory science excellence centres - Nature *Источник: Nature* *Дата: 2026-07-29* *Язык: en* **Кратко:** Fit-for-purpose regulation of medical devices and medical artificial intelligence in Europe needs Centres of Excellence in Regulatory Science and Innovation, providing research on concepts, early evidence generation, and horizon scanning on emerging needs and technologies. Access options Access Nature and 54 other Nature Portfolio journals Get Nature+, our best-value online-access subscription 27,99 € / 30 days cancel any time Subscribe to this journal Receive 12 digital issues and online access to articles 118,99 € per year only 9,92 € per issue Buy this article 39,95 € Prices may be subject to local taxes which are calculated during checkout References - Warraich, H. Fit-for-purpose regulation of medical devices and medical artificial intelligence in Europe needs Centres of Excellence in Regulatory Science and Innovation, providing research on concepts, early evidence generation, and horizon scanning on emerging needs and technologies. Access options Access Nature and 54 other Nature Portfolio journals Get Nature+, our best-value online-access subscription 27,99 € / 30 days cancel any time Subscribe to this journal Receive 12 digital issues and online access to articles 118,99 € per year only 9,92 € per issue Buy this article 39,95 € Prices may be subject to local taxes which are calculated during checkout References - Warraich, H. J., Tazbaz, T. & Califf, R. M. JAMA 333, 241–247 (2025). - Regulation for the Fourth Industrial Revolution White Paper CP111 (Secretary of State for Business, Energy and Industrial Strategy, 2019). - Gilbert, S. et al. J. Med. 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Part A: A Competitiveness Strategy for Europe (European Union, 2025). - Choose Europe for Life Sciences: A Strategy to Position the EU as the World’s Most Attractive Place for Life Sciences by 2030 COM(2025) 525 (European Commission, 2025). - Centers of Excellence in Regulatory Science and Innovation (CERSIs) (US Food and Drug Administration, 2025); https://go.nature.com/3Racp8h - Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs) (Medicines and Healthcare products Regulatory Agency, 2025). - MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner. Medicines and Healthcare products Regulatory Agency (2025). - Facts & Figures 2024 (MedTech Europe, 2024). - MedTech Europe IVDR & MDR Survey Results 2024 (MedTech Europe, 2025). - Gilbert, S., Cavicchi, B., Vuorinen, H. & Florindi, F. EU R&I Policy as an Enabler of MedTech Innovation: Addressing Development and Market Integration Challenges (European Union, 2025). - Barbier, L., Moscariello, P., Leufkens, H. G., Herold, R. & Pasmooij, A. M. G. Nat. Rev. Drug Discov. 24, 485–486 (2025). Acknowledgements We acknowledge the use of the ChatGPT language model (GPT-4 and GPT-5, OpenAI) for assisting in refining some text of this manuscript. Author information Authors and Affiliations Contributions A.S. and S.G. developed the concept of the manuscript. A.S. and S.G. wrote the first draft of the manuscript. A.S., A.K.D., A.F.F., C.J., T.M., K.S. and S.G. contributed to the writing, interpretation of the content and editing of the manuscript, revising it critically for important intellectual content. A.S., A.K.D., A.F.F., C.J., T.M., K.S. and S.G. had final approval of the completed version. A.S., A.K.D., A.F.F., C.J., T.M., K.S. and S.G. take accountability for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Corresponding author Ethics declarations Competing interests A.K.D. declares that he is supported by the UK Centre of Excellence for Regulatory Science and Innovation in AI and Digital Health. A.F.F. declares that he is supported by the UK Centre of Excellence on in-silico Regulatory Science and Innovation. K.S. declares that he is supported by the UCSF/Stanford Center for Excellence in Regulatory Science and Innovation. A.S., C.J., T.M. and S.G. declare no competing interests. Peer review Peer review information Nature Biomedical Engineering thanks Derek Hill and the other, anonymous, reviewer(s) for their contribution to the peer review of this work. About this article Cite this article Schönfelder, A., Denniston, A.K., Frangi, A.F. et al. European Union innovation needs regulatory science excellence centres. Nat. Biomed. Eng (2026). https://doi.org/10.1038/s41551-026-01756-x - Published: - Version of record: - DOI: https://doi.org/10.1038/s41551-026-01756-x [Оригинал](https://www.nature.com/articles/s41551-026-01756-x)