The Class I Fallacy: Why Low Risk Does Not Mean "No Data" Under EU MDR
There is a dangerous, widely held belief circulating among medical device manufacturers: “Because our device is Class I, we don’t need a real literature search, a State of the Art (SOTA) analysis, or any actual clinical data.” This assumption is leading companies straight into major audit non-conformities. While Article 10(9) and Article 83(1) of the EU Medical Device Regulation (MDR 2017/745) state that Quality Management Systems and Post-Market Surveillance must be proporti
