Post-market Clinical Follow-up (PMCF) Studies For Medical Devices
A Post-Market Clinical Follow-up (PMCF) study is a type of clinical investigation that is conducted on medical devices after they have been placed on the market. The aim of PMCF studies is to collect additional data on the safety and performance of medical devices, and to identify any potential issues that may not have been detected during pre-market testing.
The European Union’s Medical Device Regulation (MDR 2017/745) requires that a Post-Market Clinical Follow-up (PMCF) study be conducted as part of the post-market surveillance (PMS) requirements for medical devices. The main purpose of PMCF studies is to gather additional clinical evidence on the safety and performance of medical devices after they have been placed on the market, in order to ensure that the device continues to be safe and effective in real-world use.
When are PMCF Studies expected to be conducted?
PMCF studies should be conducted for medical devices after they have been approved or marketed, to gather additional data on their safety, effectiveness, and usability in real-world settings. The specific timing of the PMCF study may vary depending on the device and the regulatory requirements of the country or region where it is being marketed.
| Medical Device Class | PMCF Study Requirement | Timeframe |
|---|---|---|
| Class III and Implantable devices | Mandatory | Follow-up period should take into account the expected duration of device use, the expected rate of adverse events, and the intended use population |
| Lower-risk devices with significant risks identified or long-term safety and effectiveness confirmation needed | May be required | Follow-up period should take into account the expected duration of device use, the expected rate of adverse events, and the intended use population |
| Diagnostic devices used only once | May be required | Follow-up period may be shorter than for long-term implantable devices |
| All medical devices | Recommended as part of post-market surveillance | Depends on the specific device and the need for additional data |
It’s important to note that the specific requirements for PMCF studies may vary depending on the country or region where the medical device is being marketed. The table above provides general guidelines based on the European MDR and IVDR regulations.
Why are PMCF Studies Important?
PMCF studies are required for medical devices for several reasons:
How We Can Help
With over 15+ years experience, We specialize in providing end-to-end PMCF study services for all classes of medical devices. With our deep expertise in medical device regulations, clinical research, and data management, we can help you design, execute, and report on your PMCF studies, ensuring that you meet all regulatory requirements and collect the data you need to support ongoing product development.
Our PMCF Study Services
At Techsol, we understand that every medical device company is unique, and we work closely with you to tailor our PMCF study services to your specific needs and objectives. Whether you need help designing a new PMCF study or conducting ongoing monitoring of an existing device, we can help.
- PMCF Plan Development: Communicate with Notified Bodies (NB) to confirm regulatory requirements and provide our expertise for authoring a sound PMCF plan and necessary documentation.
- Study design: Develop a comprehensive study design with specific objectives considering the device class, regulatory requirements to be fulfilled and, patient populations, and clinical outcomes.
- Data collection and management: Build a robust data collection EDC platform to capture high-quality data with all the core and optional data elments and perform end-to-end clinical data management.
- Statistical analysis: Complete final data analysis on the collected PMCF study data using advanced statistical methods and provide insights to take informed decisions about your device's safety and performance.
- Regulatory compliance: We ensure that your PMCF study meets all regulatory requirements, including those set forth by the European Union's Medical Device Regulation (MDR), and that your study results are submitted in a timely and accurate manner.
