Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives-Reference-Cited by-同舟云学术

Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives

Published:2023-05-08 Issue:6 Volume:20 Page:467-491
ISSN:1743-4440
Container-title:Expert Review of Medical Devices
language:en
Short-container-title:Expert Review of Medical Devices

Author:

Fraser Alan G¹²^ORCID,Biasin Elisabetta³,Bijnens Bart⁴,Bruining Nico⁵,Caiani Enrico G⁶,Cobbaert Koen⁷^ORCID,Davies Rhodri H⁸,Gilbert Stephen H⁹,Hovestadt Leo¹⁰,Kamenjasevic Erik³^ORCID,Kwade Zuzanna¹¹,McGauran Gearóid¹²,O’Connor Gearóid¹²,Vasey Baptiste¹³,Rademakers Frank E²

Affiliation:

1. University Hospital of Wales, School of Medicine, Cardiff University, Heath Park, Cardiff, U.K

2. KU Leuven, Leuven, Belgium

3. Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, Belgium

4. Engineering Sciences, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain

5. Department of Clinical and Experimental Information processing (Digital Cardiology), Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands

6. Department of Electronics, Information and Biomedical Engineering, Politecnico di Milano, Milan, Italy

7. Philips, Brussels, Belgium

8. Institute of Cardiovascular Science, University College London, London, U.K

9. Technische Universität Dresden, Else Kröner Fresenius Center for Digital Health, Dresden, Germany

10. Elekta, Stockholm, Sweden

11. Dedalus HealthCare GmbH, Bonn, Germany

12. Health Products Regulatory Authority, Dublin, Ireland

13. Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK

Funder

European Union Horizon 2020 Research and Innovation Programme, for the CORE–MD project

Publisher

Informa UK Limited

Subject

Biomedical Engineering,General Medicine,Surgery

Link

https://www.tandfonline.com/doi/pdf/10.1080/17434440.2023.2184685

Reference198 articles.

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2. Artificial Intelligence Is Stupid and Causal Reasoning Will Not Fix It

3. Artificial Intelligence and Statistics: Just the Old Wine in New Wineskins?

4. International Medical Device Regulators Forum. Software as a Medical Device (SaMD) Working Group. “Software as a Medical Device”: possible framework for risk categorization and corresponding considerations. IMDRF/SaMD WG/N12FINAL. 2014. Available from: https://www.imdrf.org/documents/software-medical-device-possible-framework-risk-categorization-and-corresponding-considerations.

5. Medical Device Coordination Group. MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. Available from: https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2019_11_guidance_qualification_classification_software_en_0.pdf.

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