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European Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices

ANSWERED ON THIS PAGE:

  • What is a Post-Market Clinical Follow-up (PMCF) study and when is such a study necessary?
  • How is a PMCF study different from a clinical investigation?
  • How will PMCF study requirements change under the new EU MDR?

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. Emergo's 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

PMCF studies are designed to identify the potential for residual risks of a CE marked device, and to collect data and gain clarity regarding the long-term clinical performance of the product.

Circumstances that may require PMCF studies include, but are not limited to:

  • To confirm the safety and/or clinical performance for a new indication for use or claim that has been certified (approved).
  • Significant changes have been made to the medical device or labeling, and your NB agrees that no spate pre-CE-marking study is necessary.
  • Risk classification of the device has increased.
  • Post-market surveillance activities have raised questions about safety, clinical performance, or effectiveness.
  • If pre-CE-Marking safety and clinical performance study did not or could not sufficiently address certain aspects.
  • Unanswered questions regarding long-term safety or performance, or risks already identified from other similar devices.
  • On request from your Notified Body or regulatory authority.

Emergo can help you evaluate if your circumstances warrant a PMCF study. A discussion with your Notified Body may be necessary - we can assist with that as well.

Our global team can help with PMCF study analysis and compliance

The MDR places even greater emphasis on PMCF and introduces changes to the procedure for demonstrating PMCF compliance. In fact, data accepted under the current MDD may no longer be acceptable or sufficient under the new MDR. Emergo has in-house consulting teams located in the United States, Europe, and beyond who are experts in clinical data analysis and European compliance. Here’s how we can help:

  • assist with creating your PMCF plan and necessary documentation
  • clearly define the objective of your post-market clinical follow-up study
  • negotiate with your NB upfront to ensure they find the proposed study plan acceptable
  • design the study and create a protocol
  • execute the PMCF study in Europe and in certain countries beyond
  • analyze data from your study to determine acceptability under the MDR
  • help implement the consequences of a labeling change, impact on the Risk Management File, and--under the MDR--update the Summary of Safety and Clinical performance

Contact us to learn how we can help you navigate PMCF study requirements and maintain European compliance.

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Common 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.