This document provides guidance on the design and conduct of clinical studies to determine the
performance characteristics of new intrauterine devices. It also provides advice on the analysis of data
when the study is completed, as well as interpretation of these results by manufacturers, researchers
and regulatory bodies.
It is intended to ensure the scientific conduct of the clinical investigation and the credibility of the
clinical investigation results, and to assist sponsors, monitors, investigators, ethics committees,
regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Certain clinical trial concerns are not addressed in this document, including subject compensation,
confidentiality of subjects and their records, use of local ethics committees, etc. These and many other
clinical trial design issues are covered in great detail in ISO 14155.