What is Post Market Clinical Follow-up?
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 (per 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.
- Potential for quicker execution than other data collection methods such as trials
- No ethics review or competent authority approval required
- Can be designed and conducted fully remotely
- 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
A PMCF Plan, Survey, and Report require strong collaboration among marketing, clinical and regulatory functions. Quality, regulatory and clinical expertise is required at every step to ensure success and a good investment of your resources. The PMCF survey should have a clear objective and not have conflicting purposes that could confuse the respondent. Your survey respondent can lose focus easily if you try to cover too many diverse topics, resulting in less useful data needed to meet the requirements of the Medical Device Regulation (“MDR”).
- PMCF Plan per EU MDR
- PMCF Survey Plan development
- Development of questionnaires
- Scoping of the survey
- Determine suitable endpoints
- Delivery of electronic survey using the proprietary tool – FastPMCF™
- Determine feasibility of survey execution
- Sample size calculations and statistical justification
- Assist in communication with Notified Body
- Data analysis and reporting
