The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
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.