Periodic Safety Update Report (PSUR) and Post-Market Surveillance Report (PMS Report)

The MDR and IVDR require either a “Post-market surveillance report” or a “Periodic safety update report” from medical product manufacturers.

The periodic safety update report is abbreviated as “PSUR”, the post-market surveillance reports as “PMS report”. A synonym of PSUR is “safety report”.

PSUR and PMS report: Regulatory background and objectives

The European Commission has significantly increased the requirements for monitoring products with the directives (MDRIVDR). According to section 1 in chapter VII of the MDR or IVDR, the manufacturer must establish a surveillance system which is normally part of the quality management system. Corresponding instructions for conduct should be, for example:

  • Data that the manufacturer collects after marketing
  • Channels to reach the manufacturer via these data
  • Methods for analysing the data
  • Specifications to decide how to react to the data
  • Lists of possible measures (CAPA, reports to authorities, recall, etc.)
  • Documentation of this process

The manufacturer must document this surveillance specific to product in a Post-Market Surveillance Plan (MDR article 84, IVDR article 79). The MDR and the IVDR also require the manufacturer to document the results of this surveillance.

For medical devices on class 1, this report is called “Post-Market Surveillance Report”). For products of class IIa and higher, the report is called “Periodic Safety Update Report”, PSUR.

The goal of both reports is to provide authorities or the designated office a rapid overview of the post-market activities, in particular about the implementation of the plan, the data collected, the conclusions and actions.

Further information

Here you can read more about the topic of Post-Market Surveillanceand the delimitation of the post-market clinical follow-up and vigilance.

Content of the Reports (PSUR, PMS report)

Because the safety report (Periodic Safety Update Report) must be created for the higher-classed products, it contains more data compared to the PMS report.

Contents

PMS report

PSUR

Summary of the results

X

X

Conclusions from analyses

X

X

CAPAs taken (with justification)

X

X

Conclusions from the risk-benefit consideration

 

X

Sales volume, uses, patients

 

X

Both reports should answer questions such as:

  • Was the plan followed? Where were there deviations?
  • Which data were collected? What did the data look like?
  • Is patient safety still guaranteed?
  • Is the product still of benefit (measured against the state of the art of technology)?
  • Which actions were taken and why?
  • Why were no actions necessary?

Update of reports: Frequency

The frequency of report updates depends on the class:

Class

Frequency

Type of report

MDR: Class
IIVDR: Classes A and B

As needed

PMS report

MDR: Class IIa

As needed, at least every two years

PSUR

MDR: Classes IIb and III
IVDR: Classes B and C

As needed, at least once a year

PSUR

Contrary to the MDR, the IVDR only differentiates between two intervals: Either as needed or at least once a year.

Caution

The manufacturer should not confuse the regulatory specifications on the frequency of update with the frequency of data collection and analysis. The latter may be necessary on a weekly basis, such as for IT security data.

Recipients of the PSUR and PMS reports

The manufacturer does not create these reports only for themselves. They are intended for the following recipients:

Class

Authority (upon request)

Appointed body

Eudamed

MDR: Class I
IVDR: Classes A and B

X

 

 

MDR classes IIa and IIb
IVDR: Class C

X

X

 

MDR: Class III and implantable products
IVDR: Class D

X

X

X

Periodic Safety Update Report – Structure

A Post-Market Surveillance Report could contain the following chapter structure:

  1. Meta-information including references
  2. Implementation of the plan
  3. Product data (incl. sales, uses, patients)
  4. Overview of data (incl. adverse events)
  5. Results of analysis (incl. trends)
  6. Overview of actions taken (incl. CAPA, vigilance, FSCA ...)
  7. Conclusions from the risk-benefit ratio
  8. Final assessment
Periodic Safety Update Report

Fig. 1: Overview of content of a Periodic Safety Update Report PSUR (safety report)

Manufacturers must present the safety report (PSUR) or the PMS report as part of the technical documentation pursuant to annex III “in clear, organized, easily searchable and unmistakable form”.

We'd be glad to help!

Our E-Learning platform contains more than 100 templates (incl. PSUR) that help in creating technical documentation quickly and in a compliant form.

The Johner Institute will assume post-market surveillance activities upon request, including creating the relevant reports (PSUR, PMS report). Please Contact us!