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.
Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form.
This document provides guidance on:
• the criteria to be used for deciding when to exchange information,
• the procedures to follow when exchanging information,
• the forms to use for exchanging information,
• the requirements for IMDRF members participation in the NCAR Exchange Program.