CE Mark for a medical device is mandatory. The CE mark must be applied to medical devices that are covered by the European New Approach Directives (EU Directives) and Regulations (EU Regulations).
By affixing the CE mark, the manufacturer, the European Authorized Representative or the European importer confirms, and takes the responsibility, that his product complies to the European safety requirements.
“CE Mark Medical offers a wide range of practical, technical and legal services for companies in the process of CE Certification.”
A medical device bearing the CE Mark has free access to the entire market within the European Economic Area (EEA). Products that are not in compliance with the associated legislation (Directives or Regulations) and which do not bear the CE mark, are not permitted to be traded or put into use within the EEA.