MDD Europe Post Market Clinical Follow Up (PMCF)

MDD European system, even if a Medical Device has gained CE Marking based on clinical evidence from substantially equivalent similar device(s), it is a MUST to conduct PMCF.
If the manufacturer has provided long-term clinical data on the actual device to demonstrates safety, performance, intended use and stability, a PMCF 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.

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.

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 device registry.
  • Review of relevant retrospective data from patients previously exposed to device

              A study plan is executed considering the following points

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

The circumstances under which PMCF 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 PMCF study must help the manufacturer and Notified Body

(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) PMCFs should have adequate interim follow-up periods for early detection of problems as well as long term follow-up.
(4) PMCF procedure, plans and relevant records should be controlled and submitted to NB.

• MEDDEV 2.7.1 Rev. 3 outlines the stages of clinical evaluations; the general principles of a thorough, objective, and ethical clinical evaluation; the sources of data, appraisal, and analysis of clinical data; and the necessary reporting.6
• EN ISO 14155:2011 defines good clinical practice for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
• EN ISO 14155:2011 specifies general requirements intended to protect the rights, safety, and well-being of human subjects; ensures the scientific conduct of the clinical investigation and credibility of the results; define the responsibilities of the sponsor and principal investigator; and assist sponsors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices.9
• MEDDEV 2.7.3 gives guidance on what is reportable in a clinical investigation as ‘incidents’ are not ‘adverse events’.10


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