MedTech Dive May 3, 2024
Some AI products that currently can be put on the market without conformity assessment will move to a higher risk class, requiring more scrutiny.
Dive Brief:
- A U.K. agency outlined its position on the regulation of artificial intelligence as a medical device in a policy paper published Tuesday.
- The Medicines and Healthcare products Regulatory Agency (MHRA) said many AI products that can be put on the market now without conformity assessment will move to a higher risk category in upcoming reforms.
- The paper explains how MHRA interprets a government AI strategy focused on principles such as safety, security and robustness and aligns it with international standards.
Dive Insight:
The U.K. government committed to five cross-sector principles for the...
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