What CE Marking for a Medical AI Tool Actually Requires and What It Means for Your Platform
CE marking is not a one-time certification. Under MDR, manufacturers have ongoing post-market surveillance obligations that continue for the lifetime of the device monitoring clinical outcomes, reviewing flagged interactions, and demonstrating that the device continues to meet its clinical performance claims in real-world use. That commitment doesn’t end at certification. For platforms considering building their own medical reasoning capability, it’s where the real operational cost begins.
