CE-marking

In conformity with the requirements of the European Medical Device Regulation (MDR), any medical device sold on the European market needs to bear the CE marking of conformity (for all Medical Devices Classes), followed by the identification number of the notified body responsible for the conformity assessment procedures (for all Medical Devices Classes, apart from Class I). This obligation does not concern the medical devices used during a clinical investigation, and there are few other exceptions. Medicina Legatis verifies if this obligation is fulfilled, along with other conformity tasks, when a non-European manufacturer introduces a new medical device on the European market.