To be regarded as complete, a technical documentation should cover with appropriate depth the items listed in the document of the Global Harmonization Task Force ‘Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)’ as well as additional items required by the European legislation or, for in vitro diagnostic medical devices, ‘Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices’ as well as additional items required by the European legislation, see for these documents http://www.imdrf.org/ghtf/ghtf-archives-sg1.asp
Per essere considerata completa la documentazione tecnica deve come minimo trattare in modo adeguatamente approfondito gli elementi elencati nel documento «Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)» della Global Harmonization Task Force, nonché tutti gli elementi aggiuntivi richiesti dalla legislazione europea, oppure, per quanto riguarda i dispositivi medico-diagnostici in vitro, nel documento «Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices» nonché tutti gli elementi aggiuntivi imposti dalla legislazione europea; i documenti sono reperibili all’indirizzo http://www.imdrf.org/ghtf/ghtf-archives-sg1.asp.