CE Marking

Competent Authority (CAS) is a member state organization responsible for market surveillance to ensure that devices comply with regulations and do not endanger the health or safety of any public.

Notified Body is a conformity assessment body designated by a member state to undertake conformity assessment activities for medical.

Economic Operator is a manufacturer, an authorized representative, an importer, a distributor, or a legal person.

The manufacturer is the one who markets a device under its name or trademark.

Authorized Representative or EC Rep is in the European Union which acts on behalf of a manufacturer in relation to the specific tasks regarding written mandate according to EUMDR with the manufacturer established outside the EU.

The importer is a person within the European Union the places a device from a third country on the union market.

A distributor is a person in the supply chain other than the manufacturer or the importer, making a device available on the market until the point of putting it into service.