Learning from other Domains to Advance AI Evaluation and Testing: Medical Device Testing: Regulatory Requirements, Evolution and Lessons for AI Governance

The field of medical devices exemplifies the transformative potential of technology in addressing
healthcare challenges.
Testing in the medical device domain is intricately tied to regulatory requirements across
jurisdictions. During the pre-market phase, medical testing establishes baseline safety and
effectiveness metrics through bench testing, performance standards, and clinical studies. Post market testing ensures that real-world data informs ongoing compliance and safety improvements.
Testing is indispensable in translating technological innovation into safe and effective medical
devices.
The regulation of medical devices plays a foundational role in safeguarding public health by
ensuring that devices are safe, effective, and high-quality. In the global marketplace, the United
States, the UK Medicines and Healthcare Products Regulatory Agency (MHRA), and the European
Union represent some of the most influential regulatory jurisdictions, each with comprehensive
frameworks: the U.S. Food and Drug Administration (FDA) medical device regulations, the
MHRA (MDD) and European Union Medical Device Regulation (EU MDR). While there are
country-specific differences with regards to the particular pre-market and post-market review
procedures, most developed jurisdictions regulate medical devices similarly to the US or European
models.