The CE Mark is a certification mark that indicates a product’s compliance with EU health, safety, and environmental protection standards. It is a mandatory conformity marking for certain products sold within the European Economic Area (EEA), including medical devices. Medical devices that meet the requirements of the MDR EU Regulation can be CE marked, allowing them to be sold in the EU. The CE Marking process involves a series of conformity assessments. This includes a technical documentation review, risk analysis, and clinical evaluation, to ensure that the product meets the necessary standards.
« Back to Glossary Index