Post Market Clinical Follow Up (PMCF)

Post Market Clinical Follow Up(PMCF)

If a Medical Device has gained CE Marking based on clinical evidence from a substantially equivalent and similar device, it is a must to conduct post market clinical follow up..

If the manufacturer has provided long-term clinical data on the actual device to demonstrate safety, performance, intended use and stability, a post market clnical follow up study may not be necessary.

This page provides important things to be followed by the Organization for conducting Post market clinical follow up studies as per MEDDEV 2.12/2 rev 4 as part of maintaining Notified Body CE Certificate.

A Clinical follow up study is carried out in cases any residual risks are identified or not clear on long term clinical performance that may impact the benefit/risk ratio.

What the new EU MDR say about Post Market Clinical Follow Up (PMCF)

As per new Medical Device Regulation (EU MDR) Post Market Clnical Follow up (PMCF) shall be a continuous process that updates the Clinical Evaluation Summenry Reports and shall be addressed in the manufacturer's Post Market surveillance plan.

When conducting Post Market Clinical Follow Up , the manufacturer shall proactively collect and evaluate clinical data obtained with the aim of confirming the safety and performance throughout the expected lifetime of the device for ensuring the continued acceptability /suitablity of identified risks ( residual risk) and of detecting any emerging new risks on the basis of factual evidence collected.

A PMCF study plan is executed considering the following points

  • The patient population
  • Inclusion/Exclusion criteria
  • Selection of sites and investigators
  • Endpoints and statistical considerations.
  • Duration of the study
  • Data to be collected
  • Study endpoints
  • Analysis Plan

The circumstances under which PMCF study to be considered, include but are not limited to:

  • Novel medical technology
  • High product-related risk
  • High-risk implant/drug-device combination
  • Paediatric use high-risk devices
  • Worst case use scenario [ Severity/Treatment / hard to reach areas]
  • Unanswered questions of long-term safety and performance

A Post Market Clnical Follow Up (PMCF) study must help the manufacturer and Notified Body in the following manner

(1) Demonstrate, for its intended use, clinical safety and performance of a device through its lifetime and

(2) Device’s performance to a broad spectrum of physicians and patients.

(3) Post Market Clinical Follow up should have adequate interim follow-up periods for early detection of problems as well as long-term follow-up.

(4) Post Market Clinical Follow up procedure, plans, and relevant records should be controlled and submitted to NB.


The methodology adopted for PMCF studies shall be as follows

    • Extended follow up of patients enrolled in premarket investigations
    • A new clinical investigation
    • A review data derived from the device registry.
    • Review of relevant retrospective data from patients previously exposed to the device

What happens if a company has a device in market for a long time (legacy product). Does it need to perform Post Market Clnical Follow Up?

An established old device on the market for a long time. It is typically one that has been CE marked based on the market history of the product and on equivalence to other similar products. This creates problems under the MDR, especially in the case of the higher-risk class III and class IIb implantables because when manufacturers recertify their products under the MDR, they need to present "sufficient" clinical evidence.

The Clinical Investigation and Evaluation (CIE) working group in europe group is working on guidance to explain this term and it could not be ready very soon unfortunately.Information that is obtained through what would effectively now constitute PMCF is critically useful in such cases.

For established old medical devices, the manufacturers must search data on their products and weigh up and see if it meets the MDR requirements for sufficient clinical evidence. It means manufactures will do an analysis of data about whatever clinical data is available on their old device from national registries of implants, investigator reports, sponsored studies, other clinical studies performed on the product in other geographic jurisdictions.

Once manufacturer collect and analyze, they need to do a gap analysis between what clinical data they have and what is needed as per RMF and PMS and then put into place a Post Market Clnical Follow Up(PMCF).


What happens if a company manufactures a novel product and was CE Certified on equivalence. Is PMCF required?

A manufacturer sponcered PMCF study is required for a novel product that was CE marked based on clinical data from an “equivalent” device.

Manufacturers should be aware that the clinical data from the PMCF study in such cases will be crucial to ensuring that the product can be recertified under the MDR without further clinical data particularly for class III and IIb. But there is not enough information yet. No one is clear what kind of scrutiny will be done by NB or how to get validation for a study for a novel product for such cases..

European Commission's Medical Device Expert Group is working on bringing more clarity to the subject matter and expected bto come up with solution by the time MDR is in full swing.

Periodic Safety Update Reports (PSURs)

The results of Post Market Clinical Follow up (PMCF) under the new Medical Device Regulation (MDR) are an input into the PSUR. Read More>>>

PMCF is a continuous process to update the clinical evaluation and address the post market surveillance plan.

  • The data collected during the study should be filled by the clinical investigator in the respective clinical study report template as per the method chosen.
  • Sufficient data should be accompanied in the clinical study report, if not a justification for the same should be provided.

  • The information received from the PMS, Resudial Risk, inadequate scientific literature may lead to PMCF:


Additional Resources

  • How Post Market Clinical Follow Up Documentation Reviewed by Notified Body. Read More >>>

  • Medical Device Post Market Surveillance. Read More>>>

  • Buy Post Market Clinical Follow Up (PMCF) Procedure, Plan & Report Templates. Read More>>>

     

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