An increasing number of medical devices and invitro diagnostics incorporate artificial intelligence (AI) to support therapeutic and diagnostic applications.
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In spite of the risks connected with this innovative technology, the applicable regulatory framework does not specify any requirements for this class of medical devices. To make matters even more complicated for manufacturers, there are no standards, guidance documents or common specifications for medical devices on how to demonstrate conformity with the essential requirements. This presentation explains the common risks and pitfalls of incorporating AI in medical devices and gives an outlook on the regulatory framework.
