What is post market clinical follow-up?

PMCF is active collection of data on clinical experience with your device after market release. These activities can range from analysis of data from existing device registrations to performing a new clinical investigation. European and American regulatory requirements advise medical device manufacturers to consider PMCF as part of their Post Market Surveillance Plan. Why? Because clinical data gathered in the pre-market phase may be too limited to identify rare events or incidents. Post market clinical follow-up is crucial to identify new and unknown risks.   

Updating your Clinical Evaluation Report (CER)

Results of the PMCF, as well as vigilance and complaints, will have to be analyzed by the medical device manufacturer and reported in an updated Clinical Evaluation Report. This way the CER will reflect the current understanding of the benefits and risk of the medical device. 


Qserve can determine the PMCF strategy for your medical device and assist in factoring in marketing considerations , like country specific reimbursement requirements. Qserve can provide CRO support for setting up PMCF clinical investigations, which are in fact run similar as any clinical investigation project.

Make sure PMCF is part of your Post Market Surveillance Plan! 

Why collecting post market clinical data is important:

  • Pre-market clinical data may be too limited to identify rare events and incidents
  • Allows assessment of competitive advantages for your medical device
  • To keep an updated Clinical Evaluation Report
  • Regulatory requirements may demand PMCF
  • The new MDR will require new clinical data on your device, if your current CE marking is based on equivalence to competitor devices

What can we do for you?

Set up your PMCF strategy


Set up your PMCF clinical investigation


Update your CER based on post market clinical data


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