CE Mark certification is a mandatory requirement for medical devices sold within the European Economic Area (EEA). It indicates that a device meets EU safety, health, and performance standards as outlined in the Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).

To obtain CE marking, manufacturers must classify their medical device based on risk (Class I, IIa, IIb, or III) and undergo a conformity assessment. Higher-risk devices require evaluation by a Notified Body—an independent organization approved by EU authorities. The process includes technical documentation review, clinical evaluations, and quality management system audits (e.g., ISO 13485 compliance).

The CE mark ensures the device is safe, effective, and ready for use in the EU market. It also facilitates global trade, as many countries recognize CE certification. By achieving this mark, manufacturers gain market access, build trust with healthcare providers, and demonstrate regulatory compliance for patient safety.