What is PMS?
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.
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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