European Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
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Clinical Study Design Solutions
Medical device manufacturers increasingly need to conduct post-market clinical follow-up (PMCF) investigations to collect additional information about a product already approved for sale in Europe. Your PMCF plan and PMCF studies are essential to maintaining compliance under the new Medical Devices Regulation (MDR 2017/745), but many companies feel overwhelmed and confused by the new requirements. Pepgra global consulting team can assist with all aspects of MDR compliance, including planning, evaluating, and conducting PMCF studies for medical devices.
When to conduct PMCF studies for medical devices in Europe
A compliant CER should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The CER must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
You are required to prepare and submit a clinical evaluation report with your technical file as part of the CE Marking/conformity assessment process. However, approach the CER as a standalone document.
When to update your device CER
The initial report is just the beginning of your CER’s lifecycle. Update your CER regularly based on ongoing clinical evaluations, or as part of your post-market surveillance and vigilance operations. Updates to your CER are required:
We can assist with your EU Clinical Evaluation Reports and literature reviews
Pepgra specializes in reviewing medical device clinical data, and we can ensure your CER meets all European requirements. Our expert team of regulatory consultants brings depth of clinical experience with a range of medical devices and IVDs. We can:
Contact us for more information about how we can help you comply with MEDDEV 2.7/1 rev 4 and perform literature reviews.
Ask us for detailed information about Europe clinical evaluation report services.
Learn about the process, costs and timelines.
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See list of all officesCommon PMCF questions
What is the difference between a PMCF study and a clinical investigation?
Although there are many similarities between a clinical investigation and a PMCF investigation, there are also major differences that can make a PMCF a much more attractive option. In a PMCF study, the device is already CE marked and used within its intended purpose. In a clinical study, the devices are not yet CE marked for the intended purpose used in the study. However, the protection of subjects and high ethical standards required for a clinical investigation are identical. Download our white paper to learn about PMCF requirements in Europe.
Can I do a PMCF if I never completed a pre-Ce-Marking study for this product?
In principle, yes, and sometimes it is necessary. However, the details must be carefully assessed before making this important decision.
Do I need to do a PMCF for every product? And conduct a PMS?
No, to the first question. This is a matter of careful assessment and consideration. Yes, always to the second question. We are happy to explain the differences.
How we can help you in Europe
