The EU medical device regulation: Implications for artificial intelligence-based medical device software in medical physics
| Autor: | Z. Kwade, R. Beckers, Federica Zanca |
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| Rok vydání: | 2020 |
| Předmět: |
Medical device
Computer science media_common.quotation_subject Biophysics General Physics and Astronomy computer.software_genre 030218 nuclear medicine & medical imaging 03 medical and health sciences 0302 clinical medicine Artificial Intelligence Medical software Humans Radiology Nuclear Medicine and imaging Quality (business) Product (category theory) Medical Device Legislation Set (psychology) media_common business.industry Physics General Medicine Regulatory Submission Quality management system 030220 oncology & carcinogenesis Key (cryptography) Artificial intelligence business computer Algorithms Software |
| Zdroj: | Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB). 83 |
| ISSN: | 1724-191X |
| Popis: | Medical device manufacturers are increasingly applying artificial intelligence (AI) to innovate their products and to improve patient outcomes. Health institutions are also developing their own algorithms, to address specific needs for which no commercial product exists. Although AI-based algorithms offer good prospects for improving patient outcomes, their wide adoption in clinical practice is still limited. The most significant barriers to the trust required for wider implementation are safety and clinical performance assurance . Qualified medical physicist experts (MPEs) play a key role in safety and performance assessment of such tools, before and during integration in clinical practice. As AI methods drive clinical decision-making, their quality should be assured and tested. Occasionally, an MPE may be also involved in the in-house development of such an AI algorithm. It is therefore important for MPEs to be well informed about the current regulatory framework for Medical Devices. The new European Medical Device Regulation (EU MDR), with date of application set for 26 of May 2021, imposes stringent requirements that need to be met before such tools can be applied in clinical practice. The objective of this paper is to give MPEs perspective on how the EU MDR affects the development of AI-based medical device software. We present our perspective regarding how to implement a regulatory roadmap, from early-stage consideration through design and development, regulatory submission, and post-market surveillance. We have further included an explanation of how to set up a compliant quality management system to ensure reliable and consistent product quality, safety, and performance . |
| Databáze: | OpenAIRE |
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