AI in medical devices – a regulatory perspective

The possible application scenarios of artificial intelligence in medical technology seem endless. The use of superintelligence in particular harbours as yet untapped potential, as well as risks.

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.

But what do manufacturers have to consider when approving AI-based medical software? And how do the regulatory requirements of the European market differ from those in the USA?

The comparison shows:

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. In addition, only “locked algorithms” that have a completed learning phase are approved in the USA.

While the FDA presented a concept in 2019 with the Total Product Lifecycle (TPLC) that is intended to enable AI-based medical software to continue learning, in the EU it remains questionable for the time being: How can artificial intelligence be used effectively and safely?

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AI in medical devices – a regulatory perspective

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