Outlook for AI Regulation worldwide

This article summarizes the main differences between MDR and the previous MDD; the first one is the new rules have the legal form of “regulation” and in contrast to “directive”, it enters directly into force in the EU Member States and does not have to be transferred into national law.

Regulation pathway for AI in medical devices around the world:

  • U.S.A.: In 2019 the FDA published a discussion paper on a proposed regulatory framework for artificial intelligence in medical devices. The document is based on the principle of risk management, software-change management, guidance on the clinical evaluation of software and a best-practice approach to the software lifecycle. In 2021, the FDA published their action plan on furthering AI in medical devices. The action plan consists of five next steps, with the foremost being to develop a regulatory framework explicitly for change control of AI, a good machine learning practice and new methods to evaluate algorithm bias and robustness.
  • CHINA: China’s National Medical Products Administration (NMPA) published the “Technical Guiding Principles of Real-World Data for Clinical Evaluation of Medical Devices” guidance document. It specifies obligations concerning requirements-analysis, data collection and processing, model definition, verification, and validation as well as post-market surveillance.
  • JAPAN: Ministry of Health, Labour and Welfare is working on a regional standard for artificial intelligence in medical devices. Key points of assessment are the predictability of models, quality of data and degree of autonomy.
  • GERMANY: The Notified Bodies have developed their own guidance for artificial intelligence. The guidance document was prepared by the Interest Group of the Notified Bodies for Medical Devices in Germany (IG-NB) and is aimed at providing guidance to Notified Bodies, manufacturers and interested third parties. The guidance follows the principle that the safety of AI-based medical devices can only be achieved by means of a process-focused approach that covers all relevant processes throughout the whole life cycle of a medical device. Consequently, the guidance does not define specific requirements for products, but for processes.
  • Worldwide: The World Health Organization, too, is currently working on a guideline addressing artificial intelligence in health care.

Regulation of artificial intelligence is likewise still at the beginning of development involving various approaches. All major regulators around the globe have defined or are starting to define requirements for artificial intelligence in medical devices. There is a unanimous consensus that a high level of safety in medical devices will only be possible with suitable measures in place to regulate and control artificial intelligence, but this must not impair the development of technical innovation.