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 do PMCF study requirements change under the new EU MDR?

Unless justified by a medical-scientific rationale, medical device manufacturers need to conduct Post-Market Clinical Follow-up (PMCF) investigations to collect additional information about a product already approved for sale in Europe. A PMCF strategy outlined in a manufacturer's Post-Market Surveillance (PMS) plan is essential to maintaining compliance under the new Medical Devices Regulation (MDR 2017/745).

Unfortunately, many companies feel overwhelmed and confused by the new requirements. Emergo's clinical team can assist with the planning of 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 CE-certified (approved).
• Significant changes have been made to the medical device or labeling, and your Notified Body agrees that no 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.
• If questions regarding long-term safety or performance, or risks already identified from other similar devices still need to be addressed.
• On request from your Notified Body or regulatory authority.

Emergo can help you evaluate whether your products would not require a PMCF study. A discussion with your Notified Body may be necessary; we can assist with that as well.

Our team can assess PMCF study requirements for your device

The MDR places greater emphasis on PMCF and introduces changes to the procedure for demonstrating PMCF compliance. In fact, data accepted under the previous European Medical Devices Directive (MDD) may no longer be sufficient under the new MDR. Emergo’s consulting teams in the United States and Europe are experts in conducting PMCF studies and clinical data analysis. 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.
• Submit the necessary documents to obtain study approval as needed in a cost-efficient way.

Contact us to learn how we can help you navigate PMCF study requirements.

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.