Post Market Clinical Follow Up (PMCF)

Post Market Clinical Follow Up

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 /suitability of identified risks (residual risk) and of detecting any emerging new risks on the basis of factual evidence collected.

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 PMCF Plan.

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

This page provides important information 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.

In order to provide evidence of the long term safety and performance of the device, data received via PMS and PMCF are considered most useful for updating the CER throughout the life cycle.

PMCF is a must where there is very limited clinical data for a legacy device and becomes vital where long term data gaps or unanswered questions related to the usage of the device and certain indications, or novel features of a new device exists.

Post Market Clinical Follow Up Plan (PMCF Plan)

As per the new Medical Device Regulation (EU MDR), the Plan shall be a continuous process that updates the Clinical Evaluation Summary Reports and shall be addressed in the manufacturer's PMS Plan. A PMCF study plan is executed considering the following points

  • PMCF study plan must be designed with the aim to confirm the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks based on factual evidence.
  • PMCF plan must contain the period of study, plan number, PMCF procedure, date of planning, device information, and also confirm or disprove the acceptability of the previously identified risks, discover new risk and evaluate clinical safety and performance.
  • The PMCF plan should describe the appropriate methodology selected for the study
  • PMCF plan should contain inclusion and exclusion criteria
  • PMCF plan should describe the process of clinical data analysis and interpretation of the results.
  • Data to be collected
  • Special control measures needed to be considered and adopted during the study must be identified in the plan
  • PMCF plan should be filled with the respective details with authorization of the personnel prepared by, reviewed by and approved

A PMCF study Plan will help manufacturers and Notified Bodies in the following manner:

  • Demonstrate, for its intended use, clinical safety and performance of a device through its lifetime and
  • Device's performance to a broad spectrum of physicians and patients.
  • The Plan should have adequate interim follow-up periods for early detection of problems as well as long-term follow-up.
  • The procedure, plans, and relevant records should be controlled and submitted to NB.

Circumstances under which PMCF study to be initiated

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

Post Market Clinical Follow up Methodology

The most common methodologies adopted for PMCF studies are the following

  • 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

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:
  • 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).
  • A manufacturer sponsored 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 to come up with solution by the time MDR is in full swing.

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