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.
SummalY Technical Documentation for Demonstrating Confonnity to
the Essential Principles of Safety and Performance ofMedical Devices
(STED)
This guideline provides recommendations on the content of summary technical documentation (STED) to be assembled and submitted to a Regulatory Authority or Conformity Assessment Body.