CE Marking

Definition

A mandatory conformity marking for products sold within the European Economic Area, indicating that the product meets EU health, safety, and environmental protection requirements. For medical devices, CE marking under the Medical Device Regulation (MDR 2017/745) requires conformity assessment by a Notified Body, clinical evaluation, and ongoing post-market surveillance. CE marking is a prerequisite for market access in the EU and is a valuable regulatory intangible asset, though the transition from the Medical Devices Directive to MDR has significantly increased the time and cost of obtaining certification.