Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation

Key Points

• Assess the relationship between AI-specific regulatory frameworks and patient safety in orthopaedic devices.
• Examined FDA approval processes for AI/ML devices
• Investigated EU MDR regulations for equivalence
• Proposed future comparisons of recall rates across jurisdictions
• Identified a lack of EU MDR equivalents for approved AI/ML orthopaedic devices
• Found uncertainty in patient risk under current regulatory pathways
• Suggested that AI-specific frameworks may enhance device reliability