scope:

This Technical Report describes the current situation for medical device traceability in Europe and identifies key elements to establish a comprehensive European traceability system that would provide full traceability to the individual patient level. This Technical Report applies to medical devices, active implantable medical devices and in vitro diagnostic medical devices, including their accessories. Other devices which are custom-made or intended for clinical investigations and those in vitro diagnostic medical devices which are manufactured in health institutions and for performance evaluation are out of the scope of this document.