{"id":48742,"topic":"ai","source":"Nature","title":"European Union innovation needs regulatory science excellence centres - Nature","url":"https://www.nature.com/articles/s41551-026-01756-x","url_hash":"685ae00ad9975bdeea1f02b47897094c56db6725","author":"","summary":"European Union innovation needs regulatory science excellence centres Nature","content":"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.\nAccess options\nAccess Nature and 54 other Nature Portfolio journals\nGet Nature+, our best-value online-access subscription\n27,99 € / 30 days\ncancel any time\nSubscribe to this journal\nReceive 12 digital issues and online access to articles\n118,99 € per year\nonly 9,92 € per issue\nBuy this article\n39,95 €\nPrices may be subject to local taxes which are calculated during checkout\nReferences\n- Warraich, H. J., Tazbaz, T. & Califf, R. M. JAMA 333, 241–247 (2025). \n- Regulation for the Fourth Industrial Revolution White Paper CP111 (Secretary of State for Business, Energy and Industrial Strategy, 2019). \n- Gilbert, S. et al. J. Med. Internet Res. 25, e43682 (2023). \n- AI Airlock: The Regulatory Sandbox for AIaMD (Medicines and Healthcare products Regulatory Agency, 2024). \n- Algorithmic Accountability Act of 2023 S. 2892 (118th US Congress, 2023). \n- Proposal for a Regulation of the European Parliament and of the Council Amending Regulations (EU) 2017/745 and (EU) 2017/746 as Regards Simplifying and Reducing the Burden of the Rules on Medical Devices and In Vitro Diagnostic Medical Devices, and Amending Regulation (EU) 2022/123 as Regards the Support of the European Medicines Agency for the Expert Panels on Medical Devices and Regulation (EU) 2024/1689 as Regards the List of Union Harmonisation Legislation Referred to in its Annex I, 2025/0404 (European Commission, 2025). \n- European Political Strategy Centre. The Future of European Competitiveness. Part A: A Competitiveness Strategy for Europe (European Union, 2025). \n- 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). \n- Centers of Excellence in Regulatory Science and Innovation (CERSIs) (US Food and Drug Administration, 2025); https://go.nature.com/3Racp8h \n- Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs) (Medicines and Healthcare products Regulatory Agency, 2025). \n- MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner. Medicines and Healthcare products Regulatory Agency (2025). \n- Facts & Figures 2024 (MedTech Europe, 2024). \n- MedTech Europe IVDR & MDR Survey Results 2024 (MedTech Europe, 2025). \n- 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). \n- Barbier, L., Moscariello, P., Leufkens, H. G., Herold, R. & Pasmooij, A. M. G. Nat. Rev. Drug Discov. 24, 485–486 (2025). \nAcknowledgements\nWe acknowledge the use of the ChatGPT language model (GPT-4 and GPT-5, OpenAI) for assisting in refining some text of this manuscript.\nAuthor information\nAuthors and Affiliations\nContributions\nA.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.\nCorresponding author\nEthics declarations\nCompeting interests\nA.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.\nPeer review\nPeer review information\nNature Biomedical Engineering thanks Derek Hill and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.\nAbout this article\nCite this article\nSchönfelder, 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\n- Published: \n- Version of record: \n- DOI: https://doi.org/10.1038/s41551-026-01756-x","image_url":"https://media.springernature.com/m685/springer-static/image/art%3A10.1038%2Fs41551-026-01756-x/MediaObjects/41551_2026_1756_Fig1_HTML.png","lang":"en","published_at":"2026-07-29T10:03:55+00:00","fetched_at":"2026-07-29T10:15:04+00:00","status":"read","starred":0,"extract_state":"ok","summary_auto":"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\nAccess Nature and 54 other Nature Portfolio journals\nGet Nature+, our best-value online-access subscription\n27,99 € / 30 days\ncancel any time\nSubscribe to this journal\nReceive 12 digital issues and online access to articles\n118,99 € per year\nonly 9,92 € per issue\nBuy this article\n39,95 €\nPrices may be subject to local taxes which are calculated during checkout\nReferences\n- Warraich, H.","cluster_id":null,"extract_retries":0,"extract_error":null,"contract_version":"news_item.v1","format_contract_version":"news_item_formats.v1","dedup_url":"https://www.nature.com/articles/s41551-026-01756-x","quality_profile":{"profile_version":"extraction_quality.v2","bucket":"high","confidence":0.9,"failure_kind":"none","retryable":false,"retry_after_attempts":0,"reason":"High confidence: full text extraction produced 4680 characters.","operator_guidance":{"severity":"ok","recommended_action":"trust_full_text","next_step":"Use the extracted full text as the primary article source.","operator_label":"Ready","can_retry":false,"can_use_summary":false,"diagnostics_required":false},"content_depth":{"contract_version":"content_depth.v1","category":"full_text","label":"Full text","has_full_text":true,"has_summary":true,"content_length":4680,"summary_length":677,"usable_text_length":4680,"source_field":"content"},"legacy_collapsed":false,"signals":{"extract_state":"ok","extract_error":null,"extract_retries":0,"content_length":4680,"summary_length":677}},"news_item":{"id":48742,"canonical_url":"https://www.nature.com/articles/s41551-026-01756-x","source_url":"https://www.nature.com/articles/s41551-026-01756-x","title":"European Union innovation needs regulatory science excellence centres - Nature","source_name":"Nature","author":null,"published_at":"2026-07-29T10:03:55+00:00","locale":"en","topic":"ai","tags":[],"rss_summary":"European Union innovation needs regulatory science excellence centres Nature","full_text":"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.\nAccess options\nAccess Nature and 54 other Nature Portfolio journals\nGet Nature+, our best-value online-access subscription\n27,99 € / 30 days\ncancel any time\nSubscribe to this journal\nReceive 12 digital issues and online access to articles\n118,99 € per year\nonly 9,92 € per issue\nBuy this article\n39,95 €\nPrices may be subject to local taxes which are calculated during checkout\nReferences\n- Warraich, H. J., Tazbaz, T. & Califf, R. M. JAMA 333, 241–247 (2025). \n- Regulation for the Fourth Industrial Revolution White Paper CP111 (Secretary of State for Business, Energy and Industrial Strategy, 2019). \n- Gilbert, S. et al. J. Med. Internet Res. 25, e43682 (2023). \n- AI Airlock: The Regulatory Sandbox for AIaMD (Medicines and Healthcare products Regulatory Agency, 2024). \n- Algorithmic Accountability Act of 2023 S. 2892 (118th US Congress, 2023). \n- Proposal for a Regulation of the European Parliament and of the Council Amending Regulations (EU) 2017/745 and (EU) 2017/746 as Regards Simplifying and Reducing the Burden of the Rules on Medical Devices and In Vitro Diagnostic Medical Devices, and Amending Regulation (EU) 2022/123 as Regards the Support of the European Medicines Agency for the Expert Panels on Medical Devices and Regulation (EU) 2024/1689 as Regards the List of Union Harmonisation Legislation Referred to in its Annex I, 2025/0404 (European Commission, 2025). \n- European Political Strategy Centre. The Future of European Competitiveness. Part A: A Competitiveness Strategy for Europe (European Union, 2025). \n- 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). \n- Centers of Excellence in Regulatory Science and Innovation (CERSIs) (US Food and Drug Administration, 2025); https://go.nature.com/3Racp8h \n- Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs) (Medicines and Healthcare products Regulatory Agency, 2025). \n- MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner. Medicines and Healthcare products Regulatory Agency (2025). \n- Facts & Figures 2024 (MedTech Europe, 2024). \n- MedTech Europe IVDR & MDR Survey Results 2024 (MedTech Europe, 2025). \n- 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). \n- Barbier, L., Moscariello, P., Leufkens, H. G., Herold, R. & Pasmooij, A. M. G. Nat. Rev. Drug Discov. 24, 485–486 (2025). \nAcknowledgements\nWe acknowledge the use of the ChatGPT language model (GPT-4 and GPT-5, OpenAI) for assisting in refining some text of this manuscript.\nAuthor information\nAuthors and Affiliations\nContributions\nA.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.\nCorresponding author\nEthics declarations\nCompeting interests\nA.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.\nPeer review\nPeer review information\nNature Biomedical Engineering thanks Derek Hill and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.\nAbout this article\nCite this article\nSchönfelder, 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\n- Published: \n- Version of record: \n- DOI: https://doi.org/10.1038/s41551-026-01756-x","excerpt":"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\nAccess Nature and 54 other Nature Portfolio journals\nGet Nature+, our best-value online-access subscription\n27,99 € / 30 days\ncancel any time\nSubscribe to this journal\nReceive 12 digital issues and online access to articles\n118,99 € per year\nonly 9,92 € per issue\nBuy this article\n39,95 €\nPrices may be subject to local taxes which are calculated during checkout\nReferences\n- Warraich, H.","extraction":{"state":"ok","confidence":0.9,"error":null,"explanation":"High confidence: full text extraction produced 4680 characters.","diagnostics_url":"/api/diagnose?url=https%3A//www.nature.com/articles/s41551-026-01756-x","quality_profile":{"profile_version":"extraction_quality.v2","bucket":"high","confidence":0.9,"failure_kind":"none","retryable":false,"retry_after_attempts":0,"reason":"High confidence: full text extraction produced 4680 characters.","operator_guidance":{"severity":"ok","recommended_action":"trust_full_text","next_step":"Use the extracted full text as the primary article source.","operator_label":"Ready","can_retry":false,"can_use_summary":false,"diagnostics_required":false},"content_depth":{"contract_version":"content_depth.v1","category":"full_text","label":"Full text","has_full_text":true,"has_summary":true,"content_length":4680,"summary_length":677,"usable_text_length":4680,"source_field":"content"},"legacy_collapsed":false,"signals":{"extract_state":"ok","extract_error":null,"extract_retries":0,"content_length":4680,"summary_length":677}}},"display_formats":["compact","card","full","digest_section","json"]},"daily_stack_record":{"title":"European Union innovation needs regulatory science excellence centres - Nature","url":"https://www.nature.com/articles/s41551-026-01756-x","summary":"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\nAccess Nature and 54 other Nature Portfolio journals\nGet Nature+, our best-value online-access subscription\n27,99 € / 30 days\ncancel any time\nSubscribe to this journal\nReceive 12 digital issues and online access to articles\n118,99 € per year\nonly 9,92 € per issue\nBuy this article\n39,95 €\nPrices may be subject to local taxes which are calculated during checkout\nReferences\n- Warraich, H.","source":"Nature","date":"2026-07-29T10:03:55+00:00","content":"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.\nAccess options\nAccess Nature and 54 other Nature Portfolio journals\nGet Nature+, our best-value online-access subscription\n27,99 € / 30 days\ncancel any time\nSubscribe to this journal\nReceive 12 digital issues and online access to articles\n118,99 € per year\nonly 9,92 € per issue\nBuy this article\n39,95 €\nPrices may be subject to local taxes which are calculated during checkout\nReferences\n- Warraich, H. J., Tazbaz, T. & Califf, R. M. JAMA 333, 241–247 (2025). \n- Regulation for the Fourth Industrial Revolution White Paper CP111 (Secretary of State for Business, Energy and Industrial Strategy, 2019). \n- Gilbert, S. et al. J. Med. Internet Res. 25, e43682 (2023). \n- AI Airlock: The Regulatory Sandbox for AIaMD (Medicines and Healthcare products Regulatory Agency, 2024). \n- Algorithmic Accountability Act of 2023 S. 2892 (118th US Congress, 2023). \n- Proposal for a Regulation of the European Parliament and of the Council Amending Regulations (EU) 2017/745 and (EU) 2017/746 as Regards Simplifying and Reducing the Burden of the Rules on Medical Devices and In Vitro Diagnostic Medical Devices, and Amending Regulation (EU) 2022/123 as Regards the Support of the European Medicines Agency for the Expert Panels on Medical Devices and Regulation (EU) 2024/1689 as Regards the List of Union Harmonisation Legislation Referred to in its Annex I, 2025/0404 (European Commission, 2025). \n- European Political Strategy Centre. The Future of European Competitiveness. Part A: A Competitiveness Strategy for Europe (European Union, 2025). \n- 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). \n- Centers of Excellence in Regulatory Science and Innovation (CERSIs) (US Food and Drug Administration, 2025); https://go.nature.com/3Racp8h \n- Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs) (Medicines and Healthcare products Regulatory Agency, 2025). \n- MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner. Medicines and Healthcare products Regulatory Agency (2025). \n- Facts & Figures 2024 (MedTech Europe, 2024). \n- MedTech Europe IVDR & MDR Survey Results 2024 (MedTech Europe, 2025). \n- 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). \n- Barbier, L., Moscariello, P., Leufkens, H. G., Herold, R. & Pasmooij, A. M. G. Nat. Rev. Drug Discov. 24, 485–486 (2025). \nAcknowledgements\nWe acknowledge the use of the ChatGPT language model (GPT-4 and GPT-5, OpenAI) for assisting in refining some text of this manuscript.\nAuthor information\nAuthors and Affiliations\nContributions\nA.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.\nCorresponding author\nEthics declarations\nCompeting interests\nA.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.\nPeer review\nPeer review information\nNature Biomedical Engineering thanks Derek Hill and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.\nAbout this article\nCite this article\nSchönfelder, A., Denniston, A.K., Frangi, A.F. et al. European Union innovation needs regulatory science excellence centres. Nat. Biomed. 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Access options\nAccess Nature and 54 other Nature Portfolio journals\nGet Nature+, our best-value online-access subscription\n27,99 € / 30 days\ncancel any time\nSubscribe to this journal\nReceive 12 digital issues and online access to articles\n118,99 € per year\nonly 9,92 € per issue\nBuy this article\n39,95 €\nPrices may be subject to local taxes which are calculated during checkout\nReferences\n- Warraich, H.","full_text":"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.\nAccess options\nAccess Nature and 54 other Nature Portfolio journals\nGet Nature+, our best-value online-access subscription\n27,99 € / 30 days\ncancel any time\nSubscribe to this journal\nReceive 12 digital issues and online access to articles\n118,99 € per year\nonly 9,92 € per issue\nBuy this article\n39,95 €\nPrices may be subject to local taxes which are calculated during checkout\nReferences\n- Warraich, H. J., Tazbaz, T. & Califf, R. M. JAMA 333, 241–247 (2025). \n- Regulation for the Fourth Industrial Revolution White Paper CP111 (Secretary of State for Business, Energy and Industrial Strategy, 2019). \n- Gilbert, S. et al. J. Med. Internet Res. 25, e43682 (2023). \n- AI Airlock: The Regulatory Sandbox for AIaMD (Medicines and Healthcare products Regulatory Agency, 2024). \n- Algorithmic Accountability Act of 2023 S. 2892 (118th US Congress, 2023). \n- Proposal for a Regulation of the European Parliament and of the Council Amending Regulations (EU) 2017/745 and (EU) 2017/746 as Regards Simplifying and Reducing the Burden of the Rules on Medical Devices and In Vitro Diagnostic Medical Devices, and Amending Regulation (EU) 2022/123 as Regards the Support of the European Medicines Agency for the Expert Panels on Medical Devices and Regulation (EU) 2024/1689 as Regards the List of Union Harmonisation Legislation Referred to in its Annex I, 2025/0404 (European Commission, 2025). \n- European Political Strategy Centre. The Future of European Competitiveness. Part A: A Competitiveness Strategy for Europe (European Union, 2025). \n- 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). \n- Centers of Excellence in Regulatory Science and Innovation (CERSIs) (US Food and Drug Administration, 2025); https://go.nature.com/3Racp8h \n- Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs) (Medicines and Healthcare products Regulatory Agency, 2025). \n- MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner. Medicines and Healthcare products Regulatory Agency (2025). \n- Facts & Figures 2024 (MedTech Europe, 2024). \n- MedTech Europe IVDR & MDR Survey Results 2024 (MedTech Europe, 2025). \n- 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). \n- Barbier, L., Moscariello, P., Leufkens, H. G., Herold, R. & Pasmooij, A. M. G. Nat. Rev. Drug Discov. 24, 485–486 (2025). \nAcknowledgements\nWe acknowledge the use of the ChatGPT language model (GPT-4 and GPT-5, OpenAI) for assisting in refining some text of this manuscript.\nAuthor information\nAuthors and Affiliations\nContributions\nA.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.\nCorresponding author\nEthics declarations\nCompeting interests\nA.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.\nPeer review\nPeer review information\nNature Biomedical Engineering thanks Derek Hill and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.\nAbout this article\nCite this article\nSchönfelder, A., Denniston, A.K., Frangi, A.F. et al. European Union innovation needs regulatory science excellence centres. Nat. Biomed. 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Access options\nAccess Nature and 54 other Nature Portfolio journals\nGet Nature+, our best-value online-access subscription\n27,99 € / 30 days\ncancel any time\nSubscribe to this journal\nReceive 12 digital issues and online access to articles\n118,99 € per year\nonly 9,92 € per issue\nBuy this article\n39,95 €\nPrices may be subject to local taxes which are calculated during checkout\nReferences\n- Warraich, H.","source":"Nature","date":"2026-07-29T10:03:55+00:00","content":"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.\nAccess options\nAccess Nature and 54 other Nature Portfolio journals\nGet Nature+, our best-value online-access subscription\n27,99 € / 30 days\ncancel any time\nSubscribe to this journal\nReceive 12 digital issues and online access to articles\n118,99 € per year\nonly 9,92 € per issue\nBuy this article\n39,95 €\nPrices may be subject to local taxes which are calculated during checkout\nReferences\n- Warraich, H. J., Tazbaz, T. & Califf, R. M. JAMA 333, 241–247 (2025). \n- Regulation for the Fourth Industrial Revolution White Paper CP111 (Secretary of State for Business, Energy and Industrial Strategy, 2019). \n- Gilbert, S. et al. J. Med. Internet Res. 25, e43682 (2023). \n- AI Airlock: The Regulatory Sandbox for AIaMD (Medicines and Healthcare products Regulatory Agency, 2024). \n- Algorithmic Accountability Act of 2023 S. 2892 (118th US Congress, 2023). \n- Proposal for a Regulation of the European Parliament and of the Council Amending Regulations (EU) 2017/745 and (EU) 2017/746 as Regards Simplifying and Reducing the Burden of the Rules on Medical Devices and In Vitro Diagnostic Medical Devices, and Amending Regulation (EU) 2022/123 as Regards the Support of the European Medicines Agency for the Expert Panels on Medical Devices and Regulation (EU) 2024/1689 as Regards the List of Union Harmonisation Legislation Referred to in its Annex I, 2025/0404 (European Commission, 2025). \n- European Political Strategy Centre. The Future of European Competitiveness. Part A: A Competitiveness Strategy for Europe (European Union, 2025). \n- 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). \n- Centers of Excellence in Regulatory Science and Innovation (CERSIs) (US Food and Drug Administration, 2025); https://go.nature.com/3Racp8h \n- Guidance: Centres of Excellence for Regulatory Science and Innovation (CERSIs) (Medicines and Healthcare products Regulatory Agency, 2025). \n- MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner. Medicines and Healthcare products Regulatory Agency (2025). \n- Facts & Figures 2024 (MedTech Europe, 2024). \n- MedTech Europe IVDR & MDR Survey Results 2024 (MedTech Europe, 2025). \n- 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). \n- Barbier, L., Moscariello, P., Leufkens, H. G., Herold, R. & Pasmooij, A. M. G. Nat. Rev. Drug Discov. 24, 485–486 (2025). \nAcknowledgements\nWe acknowledge the use of the ChatGPT language model (GPT-4 and GPT-5, OpenAI) for assisting in refining some text of this manuscript.\nAuthor information\nAuthors and Affiliations\nContributions\nA.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.\nCorresponding author\nEthics declarations\nCompeting interests\nA.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.\nPeer review\nPeer review information\nNature Biomedical Engineering thanks Derek Hill and the other, anonymous, reviewer(s) for their contribution to the peer review of this work.\nAbout this article\nCite this article\nSchönfelder, A., Denniston, A.K., Frangi, A.F. et al. European Union innovation needs regulatory science excellence centres. Nat. Biomed. 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