Periodic Safety Update Reports

Periodic Safety Update Report (PSUR)

New Medical Device Regulation (MDR) has significantly increased the requirements for monitoring Medical Device after its release to market and customers /patient usage.

MDR /IVDR chapter VII, explains the manufacturer must establish a surveillance system as part of Harmonized Standard EN ISO 13485:2016 implemented and monitored.

  • Post market data collected.
  • Methods for analyzing the collected data
  • Actions taken to counter the data
  • Actions taken such as CAPA, Vigilance, Recall etc.;
  • Analysis and Conclusion of Data

The above are collected and documented as per PMS Plan mentioned in article 84 and article 79 in MDR & IVDR respectively.

As per MDR / IVDR class 1 device permitted to keep Post Market Surveillance Report (PMSR) and Class 11a, Class 11b & Class 111 products Periodic Safety Update Report (PSUR)

Content of Periodic Safety Update Report (PSUR)

  • Summary of the PMS
  • Data analysis and Conclusions / Result
  • CAPAs taken against actions.
  • Result of Risk Analysis / Residual Risks
  • Sales volume, Geographical Location, User group

Periodic Safety Update Report (PSUR) Timeline

Class 1

PMSR

On Request

When Necessary

Class 11a

PSUR

NB Conformity Assessment Review

Every 24 months

Class 11b (Non Implant)

PSUR

NB Conformity Assessment Review

12 months

Class 11b (Implant)

PSUR

EUDAMAD / NB Conformity Assessment Review

12 months

Class 111

PSUR

EUDAMAD / NB Conformity Assessment Review

12 months

IVD Class A,B

PMSR

On Request

When Necessary

IVD C

PSUR

NB Conformity Assessment Review

12 months

IVD D

PSUR

EUDAMAD / NB Conformity Assessment Review

12 months

Need help with Periodic Safety Update Reports (PSUR) Data Analysis & Writers. Contact us.

Case Study Presentation


  • Is a plan followed by the manufacturer? Are there any deviations against written down plan?
  • Which data were collected? Is the data sufficient to analyzes the device features?
  • Is patient safety proved?
  • Is the device found good when measured against the state of the art technology?
  • What action and when taken and for what reason?
  • Why were no actions necessary. Is the result of PSUR welcoming?

MDR article 33 mentioned it should be submitted to EUDAMED. There is NO correct information so far.

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