{"id":739,"date":"2026-05-21T13:53:51","date_gmt":"2026-05-21T13:53:51","guid":{"rendered":"https:\/\/lisconsultgroup.com\/?p=739"},"modified":"2026-05-21T13:53:52","modified_gmt":"2026-05-21T13:53:52","slug":"bringing-an-ai-powered-diagnostic-tool-to-the-european-market","status":"publish","type":"post","link":"https:\/\/lisconsultgroup.com\/index.php\/2026\/05\/21\/bringing-an-ai-powered-diagnostic-tool-to-the-european-market\/","title":{"rendered":"Bringing an AI-powered diagnostic tool to the European market"},"content":{"rendered":"\n

<\/h3>\n\n\n\n

The situation<\/strong><\/h2>\n\n\n\n

A medtech startup had developed an AI-powered image analysis software designed to assist radiologists in detecting early-stage lung nodules. Clinically promising and technically robust, the product was ready for commercialisation \u2014 but the regulatory pathway to the European market was far from straightforward. The company approached LIS Consulting to define a compliant route to CE marking.<\/p>\n\n\n\n

The challenge<\/strong><\/h2>\n\n\n\n

AI-driven diagnostic tools sit at the intersection of two complex regulatory frameworks. First, the software had to be qualified and classified as a Software as a Medical Device (SaMD) under MDR 2017\/745. Given its intended purpose \u2014 directly influencing clinical decisions \u2014 it was classified as Class IIb, triggering mandatory notified body involvement. Second, because the output of the software informed diagnostic conclusions, questions arose about whether IVDR 2017\/746 applied in parallel. A thorough intended purpose analysis was required to draw the boundary clearly.<\/p>\n\n\n\n

Beyond classification, the AI\/ML nature of the product introduced additional layers of complexity:<\/p>\n\n\n\n