Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
Title:
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
Origin/Publisher:
GHTF
Document Type:
Guideline
Content:
This document is intended to provide guidance on the content of the STED for IVD medical devices to be assembled and submitted, where applicable, to a RA or CAB for premarket review, and for use post-market to assess continuing conformity to the Essential Principles.