Post Market Clinical Follow up (PMCF) is the best practice for monitoring the safety of Medical device after it has been released on the Market. Post Marketing Surveillance uses a number of approaches to monitor the safety of Medical device as per European Regulation,
This study is carried out if the residual risk impacts the risk/benefit ratio, significant changes in device design or labeling, results of any adverse events reported or any one indication or claim has been approved.
Clinical follow up study is carried out in cases any residual risks are identified or un clear on long term clinical performance that may impact the benefit or risk ratio.
Post Market Clinical Follow Up ( PMCF) is a part of Post Market Surveillance (PMS)
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
Implementation of study
Study is conducted every year according to the plan and data collected are reviewed at the end of the year. The data and conclusions derived from the Post Market Clinical Follow up study are reported as PMCF study report. Post Market Clinical Follow up (PMCF) study report is used to provide clinical evidence for the clinical evaluation process and verification of device continues to comply with the Essential Requirements. Based on the study appropriate corrective or preventive actions, implemented.
Study shall be executed with adequate control measures to assure compliance with the Plan.
Data analysis is carried out with conclusions drawn according to the analysis plan.
Final report is prepared with conclusions relating back to the original objective of the study
The conclusions derived from PMCF studies are used to provide the clinical evidence for clinical evaluation, to reassess the device comply with the essential requirements
Based on Post Market Clinical Follow up (PMCF) study corrective and preventive actions can be implemented if necessary.
Malesh M
Regulatory Consultant
+91 8050648432
Health Care Regulatory and QA Consultants 