CE Marking

CE certification verifies to regulators in Europe that medical devices meet all quality, safety and performance requirements of the applicable Medical Device Directives (including for In Vitro Diagnostic Medical Device IVD and Active Implantable Medical Device AIMD).

CE Marking shall be obtained by manufacturers prior to marketing, distribution and sale of their medical devices in any EU Member State.

Notified Body assessment is required for CE marking of moderate to high class medical devices. A regulation, binding in its entirety, is to replace the existing MD Directives in Europe: The MDR (Medical Device Regulation) replaces Medical Device Directive (MDD) and the IVDR (In Vitro Medical Device Regulation) replaces In Vitro Medical Device Directive (IVDD).