Manufacturers are finding that they do not have clinical data on their own devices, as required by the EU MDR. So they are turning to PMCF surveys as a cheap and easy way to gather the required data. Although PMCF surveys can be a valuable tool to collect clinical data on your own device using a PMCF survey will only work when it is designed to meet both regulatory requirements and appropriate objectives.
The aim of this Webinar was to share lessons learned from planning, execution, reporting and notified body review of PMCF surveys were discussed. Also, the second part of the webinar focussed on how to apply these lessons learned. This included scoping and definition of endpoints and acceptance criteria of the survey.