PMCF Solutions

Empowering PMCF Solutions with sufficient data

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. Our team of experts can provide comprehensive support in designing and executing PMCF surveys, ensuring high-quality data collection and analysis to meet regulatory requirements.

How does a PMCF survey work?

With your input, Qserve CRO will write the PMCF survey plan and design the questionnaire. After the finalization of the plan, the questionnaire will be programmed in an electronic data capturing (EDC) system followed by the 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.

In a high-quality PMCF survey, patient-specific clinical data is obtained based on a PMCF survey plan. Included in these plans:

Qserve CRO

Clear scope

Qserve CRO

Appropriate design including endpoints and acceptance criteria

Qserve CRO

Evaluation of potential sources of bias, including measures to reduce bias as far as possible

Qserve CRO

Statistical justification for the sample size

Qserve CRO

Questionnaire covering at least the defined endpoints

Qserve CRO

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.

Services

Qserve CRO 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

View all services

  • Sample size calculations and statistical justification
  • Delivery of electronic survey
  • Data analysis and reporting
  • Assistance with communication with the Notified Body
Qserve CRO

“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.”

Bianca Lutters / Head of CRO

Contact us today to learn more about how Qserve CRO can assist you. Together, we can navigate the regulatory landscape and ensure the success of your medical device.

Contact us

Latest news

Qserve CRO
Tips to Design a High-Quality PMCF User Survey

With the implementation of the Medical Device Regulation (2017/745) (MDR) in the EU, post-market clinical [...]

Read more
22
Nov