AI in Medical Devices: Application, Regulatory Landscape in US and EU, Ethical Challenges, and Future Outlook
Main Article Content
Keywords
Medical device, AI regulation, FDA, EU’s AI Act, Software as medical device, Ethical challenge, USA, EU, rtificial intelligence (AI)
Abstract
Background: By increasing patient management, enabling individualized treatment, and boosting diagnostic accuracy, artificial intelligence (AI) is revolutionizing the medical device market. However, issues with bias, transparency, data privacy, and regulatory compliance are brought up by its incorporation. Objective: While addressing important ethical and societal issues, this review will look at how AI is used in medical devices and contrast the legal systems in the US and the EU. Material and Methods: Scientific publications, policy documents, and regulatory guidelines pertaining to AI-based medical devices were used in a review of the literature. We gathered and compared data on applications, regulatory strategies, and ethical issues. Results: Through applications like wearable technology, personalized medicine, and diagnostic imaging, AI-based medical devices enhance clinical outcomes. While the EU implements a risk-based framework under the AI Act and MDR, emphasizing openness and human oversight, the US FDA uses a Total Product Life Cycle (TPLC)-based strategy that focuses on continuous monitoring and Good Machine Learning Practices (GMLP). Notwithstanding these developments, issues including algorithmic bias, interpretability issues, and regulatory inequalities continue to exist, particularly in low- and middle-income nations. Conclusion: Medical equipment could be greatly advanced by AI, but in order to guarantee safety and efficacy, robust legal frameworks and moral standards are crucial. For AI to be used responsibly in healthcare, global regulatory harmonization and ongoing oversight are essential.
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