Stratipath Breast received CE marking under the European Union In Vitro Diagnostic Regulation, EU 2017/746. IVDR is a substantially higher bar than the IVD Directive it replaced, requiring clinical evidence, demonstrated analytical validity and an ongoing post market surveillance commitment rather than largely self declared conformity. For an AI based prognostic tool this is one of the more demanding routes to European market access currently available.
Our readEuropean pathology labs and oncology departments can deploy the tool clinically rather than for research use only, which is the practical distinction that determines whether a result can inform a treatment decision. The post market surveillance obligation is worth weight in a vendor comparison, because it commits Stratipath to monitoring real world performance rather than resting on the validation study. Buyers comparing AI pathology vendors across regions should note that IVDR certification and FDA clearance are not interchangeable and cover different claims.