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Periodic safety update report

As per EU MDR and IVDR, PMSR shall be prepared for a class I medical devices & Class A and B in-vitro diagnostic devices, a post-market surveillance report summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as per the post-market surveillance plan.

Manufacturers of class IIa, class IIb and class III medical devices as well as class C and Class D IVD devices shall prepare a periodic safety update report (PSUR) by summarizing the results and conclusions of the analyses of the post-market surveillance (PMS) data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. PSUR shall be a part of technical documentation for all the categories mentioned above but not for custom made devices.

Throughout the lifetime of the device, that PSUR should update with following aspects:

Indian-mdr-img

When should one update PSUR?

  • Manufacturers of class IIb and class III medical devices and Class C and Class D IVD devices shall update the PSUR at least annually.
  • Manufacturers of class IIa medical devices shall update the PSUR when necessary and at least every two years.

Submission of PSUR

  • For class III medical devices or implantable devices, as well as class C and Class D IVD devices manufacturers shall submit PSURs by means of the electronic system to the notified body involved in the conformity assessment
  • For medical devices other than those mentioned in above point, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
  • The manufacturers must submit Periodic Safety Update Report in compliance with Annex III – Technical Documentation of Post Market Surveillance.

Role of consultant in writing PSUR

We, Maven Profcon Services LLP. will take upon the Post-Market Surveillance activities upon request, including Periodic Safety Update Report and Post Market Surveillance Report!!!

FAQ:

Ans. Conclusions and results of Post market surveillance data which includes Complaint data, risk monitoring, vigilance, sales data; main findings of PMCF, conclusions of benefit risk determination, an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Ans. PSUR update helps us in determining and analyzing the safety of the medical devices by identifying risks, evaluation benefit-risk ratio. It helps the manufacturer to implement necessary preventive actions.

For more information on PSUR, see our video

https://www.youtube.com/watch?v=XOinDkmtrbw&t=6s

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