Written by
Phil Grainger
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The EU AI Act, the first comprehensive regulation on AI by a major regulator, came into force at the beginning of August. The majority of the act addresses what it designates as “high-risk” use cases, which include the implementation of the technology within medical devices.
Why we are covering this topic
- The AI act has significant ramifications for the medical imaging AI industry, impacting all AI solutions that currently require the CE mark.
- AI vendors operating in Europe need to start considering how it will affect their investment in services and go-to-market strategies.
Why it matters
- The act places a greater burden on the users of the technology, and providers will expect support from AI vendors to meet these requirements.
- The impact of the act is unlikely to remain contained to the EU and may shift the competitive landscape in all major markets.
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