Periodic Safety Update Reports

Periodic Safety Update Report (PSUR)

The Periodic Safety Update Report (PSUR) is essentially an extension of a Post Market Surveillance Report (PMSR) containing information for higher risk devices.

Periodic Safety Update Report is for medium to high-risk class devices such as Class IIa, IIb & III. Inputs to Periodic Safety Reports are from Post Market Surveillance (Results and conclusions of PMS data, vigilance reporting and current status of these devices on the European Market).

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.

Periodic Safety Update report must be prepared and submitted to Notified Body and relevant Competetent Authority via EUDAMED system.

The PSUR writing must be prepared against the number of technical files the device manufacturer is holding. In short PSUR is made for each device and the intended use.

The conclusion of the PSUR is made for the respective previos year for class III and few of the class IIb devices. Lower class devices can be for a year or two

PSUR must have strong and valid explanation / justification for the below to satisfy notified body involved in the conformity assessment.

  • 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)

The contents of this report are outlined in Article 86 of the MDR listed below.

  • Summary of the PMS and covering findings of Post Market Clinical Follow Up (PMCF)
  • 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

Role of I 3 CONSULTING in writing and documenting PSUR

  • Development of Procedures and necessery templates.
  • Review of PMS data and conclusion derived by the manufacturer as per PMS plan. Unsatisfied reports; we will provide expert help to solve the issue.
  • Review of PMCF conclusion by the manufacturer. Incase of deficiency we provide expert help to solve the issue.
  • We also help in rewriting PMS and PMCF if required.
  • Review of risk-benefit ratio, resudal risk, correlate with PMS and CAPA and design changes.
  • Special emphasis on review of custom made devices.
  • Check details in PSUR against estimate evaluation of the size and other characteristics of the population using the device.
  • Modification in PSUR based on rationale and description of any preventive and corrective actions taken against each risk and CAPA.

PSUR Case Study Presentation

Need help with Periodic Safety Update Report documentation including Data Analysis & Writing. Contact via below email.


  • 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.

INDIA – Bangalore
+ 91 994 591 2081
Phone / WhatsApp


USA – Chicago
+1 630 696 1293
Phone / WhatsApp


GERMANY – Bremen
+49 2161 990 8831
Phone / WhatsApp


mail enquiry@i3cglobal.com
LiveZilla Live Chat Software