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Post Market Clinical Follow-up

Post market Clinical follow-up (PMCF) is a proactive method for collection and evaluation of clinical data, confirm the safety of device and ensure continued acceptability of the risk identified and identify new risks that may arise for the medical devices which are already in market and are CE certified. PMCF is one of the segments of Post Market Surveillance and it is a continuous process that updates the quality management system with focus to areas like clinical evaluation, and risk management.

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Purpose of PMCF

  • Conform Safety and performance of the device
  • Identify known side effects, risks, contraindication, off label use and misuse
  • To collect information regarding:
    • rare complications
    • clinical observations only seen in a larger user/patient population or long-term use of the device
  • Ensure continued acceptability of benefit risk ratio

Factors to be considered in determining the need for Post-Market Clinical Follow-up

  • Innovation
  • high product related risk
  • anatomical locations having high risk
  • high risk target populations
  • severity of disease/treatment challenges
  • unanswered questions of long-term safety and performance
  • identification of previously unstudied subpopulations which may show different benefit/risk-ratio
  • emergence of new information on safety or performance
  • interaction with other medical products or treatments
  • verification of safety and performance when exposed to larger and varied population

As per EU MDR 2017/745, the manufacturer shall consider the need to perform PMCF for every medical device and where PMCF is not required due to presence of sufficient clinical data a rational or detailed justification is to be documented within the technical documentation. As per the EU MDR, detailed and elaborated analysis of all the clinical data available needs to be performed in order to decide if PMCF is justified or not. If gaps are observed in the clinical data, PMCF studies are required.

Maven team provides complete end to end solution for your PMCF studies. Determining the need for performing PMCF studies as per EU MDR, if the PMCF studies are not applicable a detailed justification will be provided. Also, the data which is accepted under MDD may no longer be sufficient and adequate under the EU MDR. Consultants at Maven Profcon Services LLP, can help you with the following:

  • Documenting PMCF Plan
  • Define the objective of PMCF studies
  • Negotiate with notified bodies that the proposed PMCF plan are acceptable
  • Where deemed appropriate, justification for non-applicability of PMCF
  • Design PMCF studies
  • Provide monitoring services for continual collection of PMCF and preparation of PMCF report.

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