Work

Regulation of Artificial Intelligence in Medical Devices in Russia: Balancing Innovation and Safety

Year: 2025

Type: article

Abstract: This narrative review explores the current regulatory landscape governing the use of artificial intelligence (AI) in medical devices in Russia. It discusses how national regulations aim to balance technological innovation with patient safety and compares these approaches to international frameworks such as the EU MDR, FDA guidance, and IMDRF principles. The review highlights key challenges in standardization, clinical evaluation, and ethical oversight of AI-based medical technologies. It also outlines strategic directions for regulators, developers, and researchers to ensure responsible and effective integration of AI into medical device regulation.

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.17533633

Authors: Momynaliev, Kuvat, Khoroshun, Dimash, Ivanov, Igor

Institutions: All-Russian Scientific and Research Institute for Medical Engineering, National Medical Research Center for Hematology

Language: English

Topic: Healthcare Regulation

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W7104011508

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