The Medical Device Regulation 2017/745 introduced the term “sufficient clinical data” as a requirement for market approval in Europe. For devices that are CE-marked under the Medical Device Directive 93/42/EEC and do not have sufficient clinical data, a high-quality post market clinical follow-up (PMCF) survey is a popular and low-cost solution to gather clinical data. PMCF survey data collected in a country where your device has market access can be used as sufficient clinical data to obtain market access for your device in another country.
“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.”
With your input, Qserve will write the PMCF survey plan and design the questionnaire. After finalization of the plan, the questionnaire will be programmed in an electronic data capturing (EDC) system followed by deployment of the survey.
The incoming completed surveys will be reviewed and managed. When all surveys have been collected, data will be analyzed, including statistical analysis to support the endpoints of the survey are met, and a PMCF survey report will be written.Contact us