Approval of AI-based medical software
As autonomously learning software, artificial intelligence, like humans, is capable of abstract thinking. For the field of medical technology, this opens up a seemingly infinite number of possible applications.
While a weak AI is understood to be an intelligence that is only superior to humans in very specific areas, a superintelligence – equal to humans – can learn and make decisions.
However, in order to be allowed to use artificial intelligence in the development of medical technology products, manufacturers must observe various requirements. Which regulations apply to the European market and what do manufacturers have to consider in order to be able to approve the product in the USA?
In Europe, the requirements of Regulation (EU) 2017/745 for software products apply above all. This is because AI can be considered a sub-discipline of software from a technical perspective. According to Annex I No. 17 of the regulation, software must be designed to ensure repeatability, reliability and performance in accordance with its intended use.
The FDA, on the other hand, distinguishes between artificial intelligence and software-based medical devices. Moreover, only “locked algorithms” with a completed learning phase have been approved in the USA so far.
The lecture will discuss the extent to which the regulatory requirements can be implemented in Europe and the USA. The presentation will also focus on the different approaches of the EU and the FDA.