Post-sale of medical devices, it is critical to monitor how efficiently the device is working, its downtime, any faulty findings, any risk it poses to the users, end-users etc. In short, continuous monitoring of the medical device must be conducted to check its safety and performance.

The legal manufacturer must evaluate the type & frequency of the complaints to understand the severity of the risks posed to the users and thus ensuring appropriate training post sale of the product.

Efforts must be made to figure out the root cause of the complaints by using different tools of risk analysis like Decision Tree Analysis, Fishbone, FMEA, Probability Matrix, Preliminary Hazard and Final Hazard Analysis etc. As per Article 88 in MDR, this is called the Trend Reporting Events.

Any statistically significant increase in serious incidents (severity of risks) as per the trending report leads to appropriate control measures taken like the Corrective and Preventive Actions (CAPA) or the Field Safety Corrective Actions (FSCA) for any Field Safety Notice (FSN) generated.

PMS activities must be performed as per Article 83 to Article 89 including data gathering, PMS Plan, PMS/PSUR report, vigilance reporting, trend reporting, FSN and FSCA.

Post-Market Surveillance (PMS) & PSUR

  • PMS under EUMDR  
    • Stringent implementation & monitored by PRRC
    • Included in the technical documentation
    • Report to Notified Bodies & Competent Authorities
  • The PMS system will consist of 
    • PMS Procedure
    • PMS Plan, PMS Report or Periodic Safety Update Report (PSUR)
  • PMS system will be used to update 
    • Design & Manufacturing information
    • IFU & Labels
    • Clinical Evaluation
    • Summary of Safety & Clinical Performance (SSCP)
    • Benefit-Risk determination
  • Periodic Safety Update Report (PSUR)
    • Class IIa, IIb & III manufacturers
    • Included in the technical documentation
    • Reporting every 2 years or annually depending upon the class of medical devices
  • PSUR must address 
    • Main findings of PMCF
    • Conclusion of benefit-risk determination
    • Sales Volume
    • No. of Complaints
    • No. of Patients (sample size)
    • Patient Characteristics
    • Medical Device Usage Frequency (applicable)

IZiel Healthcare offers PMS services to our clients where we perform end to end Post Market Surveillance activities. These services can be PMS Plan, PMS/PSUR Reports, PMCF Plan and Reports, Trend Reporting, Complaint Handling, Clinical Evaluation, Risk Benefit Management and many more.

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