Medical device traceability enabled by unique device identification (UDI)
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This Technical Report identifies key elements needed for a European system that would provide 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.
Medical device traceability enabled by unique device identification (UDI)
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