Europe – IMDRF: Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form

This document was developed by the IMDRF National Competent Authority report (NCAR) Exchange Program Working Group as an update to the original document (N79) authored by Study Group 2 of the Global Harmonization Task Force (GHTF) in relation to the GHTF Exchange Program.
This document concerns a two-way communication system involving confidential information for serious public health issues.
This document will provide guidance, procedures and forms for exchange of reports between IMDRF members. Other forms of information exchange may be addressed in the future…