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.
How does a PMCF survey work?
In a high-quality PMCF survey, patient-specific clinical data is obtained based on a PMCF survey plan. Included in these plans:
Appropriate design including endpoints and acceptance criteria
Evaluation of potential sources of bias, incl. measures to reduce bias as far as possible
Statistical justification for the sample size
Questionnaire covering at least the defined endpoints
Methods for data collection and data analysis
The questionnaire in the survey will be completed by end-users based on the information documented in a patient chart.
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
Qserve provides the following services to assist with PMCF surveys:
- Survey plan development
- Development of questionnaires
- Scoping of the survey
- Determine suitable endpoints and acceptance criteria
- Determine feasibility of survey execution
- Sample size calculations and statistical justification
- Delivery of electronic survey
- Data analysis and reporting
- Assistance with communication with Notified Body