27/04/2026
Certification is seen as the end point for AI medical devices.
Post-market reality tells a different story.
AI systems evolve once deployed in real clinical environments.
Performance shifts, data patterns change, and new risks appear over time.
These 5 realities highlight what happens after approval in AI post-market surveillance.
โข Continuous ๐บ๐ผ๐ป๐ถ๐๐ผ๐ฟ๐ถ๐ป๐ด ๐ฏ๐ฒ๐ฐ๐ผ๐บ๐ฒ๐ ๐ฒ๐๐๐ฒ๐ป๐๐ถ๐ฎ๐น
โข ๐ ๐ผ๐ฑ๐ฒ๐น ๐ฑ๐ฟ๐ถ๐ณ๐ must be anticipated
โข Regulatory changes can be triggered by ๐๐บ๐ฎ๐น๐น ๐๐ฝ๐ฑ๐ฎ๐๐ฒ๐
โข Real-world evidence is required to confirm ๐ฝ๐ฒ๐ฟ๐ณ๐ผ๐ฟ๐บ๐ฎ๐ป๐ฐ๐ฒ ๐ผ๐๐ฒ๐ฟ ๐๐ถ๐บ๐ฒ
Post-market surveillance defines whether an AI medical device remains safe and effective in practice.
