CE Marking
A certification mark indicating that a product conforms to EU health, safety, and environmental protection standards. For medical devices, CE marking under EU MDR requires assessment by a Notified Body (for Class IIa and above).
CE marking (Conformité Européenne) is the mandatory conformity marking for products sold in the European Economic Area. For medical devices, it indicates compliance with EU MDR 2017/745 or EU IVDR 2017/746.
CE marking process for medical devices
Class I devices: Self-declaration by the manufacturer. Class IIa, IIb, and III devices: Requires conformity assessment by a Notified Body, including review of the Quality Management System, Technical Documentation, and Clinical Evaluation Report.
In tender context
EU tenders require valid CE marking with a Declaration of Conformity referencing the current regulation (MDR, not the old MDD). The CE certificate must be current — expired certificates are a common compliance failure in tender evaluations.