Post Market Clinical Follow-up (PMCF)
Performing post-market clinical investigation for medical device
What is Post Market Clinical Follow-up?
PMCF is an active collection of data on the clinical experience of your device aftermarket 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. The primary reason is that the 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 per EU MDR
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").
Key Advantages of PMCF Surveys
PMCF Services Offerings
- 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
CLIENT TESTIMONIALS
We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”
Case Studies
We have provided a few projects which we have executed for our customers. Please reach out to us for more details.
