PMCF - Post Market Clinical Follow up

PMCF surveys for remote data collection

PMCF

Post Market Clinical Follow-up

PMCF is an active collection of data on clinical experience with your device after market release. PMCF activities can range from an analysis of data from literature or existing device registries to performing a new post-market clinical investigation. European and American regulatory requirements require medical device manufacturers to consider PMCF as part of their Post Market Surveillance Plan. Why? Because clinical data gathered in the pre-market phase may be too limited to identify rare events or incidents and it may not be fully representative of real-world use. Post Market Clinical Follow-up is crucial to identify any emerging or previously unknown risks and to confirm the safety and performance of the device throughout its lifetime

 

 

 

PMCF surveys for remote data collection

Due to the COVID-19 pandemic, many clinical investigations other than those aimed at management of the disease have been postponed or suspended. For medical device manufacturers, this is particularly unfortunate. The EU Medical Devices Regulation (MDR) 2017/745 reinforces the rules on clinical evidence. In practice, this means that for many devices currently on the market additional clinical data will have to be generated to enable CE-marking under the MDR. Data collection takes time, and even with the MDR’s date of application postponed to 26 May 2021, study delays could mean that manufacturers will not have sufficient clinical evidence by the time their current CE-certificate expires.


But clinical investigations are not the only method of clinical data collection. Depending on the clinical data gap that needs to be addressed, post-market clinical follow-up (PMCF) surveys can be a valuable data collection tool. In fact, user surveys (collecting of user feedback) are listed in the MDR as a valid method of post-market clinical data collection (see MDR Annex I Part B, clause 6.2a). PMCF surveys can be performed fully remotely with no need for clinical personnel to visit hospitals and no need for patient contact.

Some of the main advantages of PMCF surveys:

  • Can be designed and conducted fully remotely
  • Potential for quicker execution than other data collection methods such as trials
  • No ethics review or competent authority approval required
  • High-quality data can be obtained
  • The fraction of the budget of a clinical trial
  • Can help obtain sufficient clinical evidence and meet PMCF requirements
  • Collect data on general user experience or on single-use cases

Overview of services we offer for PMCF surveys:

Survey Plan development

Development of questionnaires

Scoping of the survey

Determine suitable endpoints

Delivery of electronic survey

Determine feasibility of survey execution

Sample size calculations and statistical justification

Assist in communication with Notified Body

Data analysis and reporting

The way Qserve works (full service survey):

  1. Quotation
  2. Review of clinical documentation
  3. Develop survey with input of customer
  4. Program Electronic Data Capture (EDC) system
  5. Test-run of survey with select number of respondents
  6. Final adjustments to survey
  7. Customer invites healthcare providers (HCPs) to fill in the survey*
  8. Data analysis and reporting

* customer remains responsible for obtaining survey responses, Qserve can advise on different strategies of execution.

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