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

Author:

Fraser Alan G12ORCID,Biasin Elisabetta3,Bijnens Bart4,Bruining Nico5,Caiani Enrico G6,Cobbaert Koen7ORCID,Davies Rhodri H8,Gilbert Stephen H9,Hovestadt Leo10,Kamenjasevic Erik3ORCID,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

Reference198 articles.

1. McCarthy J, Minsky M, Rochester N, et al. A proposal for the dartmouth summer research project on artificial intelligence. August 1955. Available from: file:///C:/Users/wcgagf/Downloads/McCarthy,%20Minsky,%20Rochester,%20Shannon%20(1955)%20-%20A%20Proposal%20for%20the%20Dartmouth%20Summer%20Research%20Project%20on%20Artificial%20Intelligence.pdf (Accessed 2022 May 19.

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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