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”.
The European Commission has significantly increased the requirements for monitoring products with the directives (MDR, IVDR). 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:
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.
Here you can read more about the topic of Post-Market Surveillanceand the delimitation of the post-market clinical follow-up and vigilance.
Because the safety report PSUR must be created for the higher-classed products, it contains more data compared to the PMS report.
Summary of the results
Conclusions from analyses
CAPAs taken (with justification)
Conclusions from the risk-benefit consideration
Sales volume, uses, patients
Both reports should answer questions such as:
To identify a PSUR, MDCG guidance document 2022-21 "Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745" now refers to a "PSUR reference number". The manufacturer assigns this unique identifier to each PSUR. It remains unchanged throughout the lifetime of the PSUR.
The frequency of report updates depends on the class:
Type of report
MDR: Class IIa
As needed, at least every two years
MDR: Classes IIb and III
As needed, at least once a year
Contrary to the MDR, the IVDR only differentiates between two intervals: Either as needed or at least once a year.
A PSUR is required throughout the lifetime of the product: The lifetime of a product is the period of time specified by the manufacturer in the product documentation during which the product is expected to remain safe and effective. This means a PSUR must be prepared until the lifetime of the last product placed on the market is reached.
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.
The manufacturer does not create these reports only for themselves. They are intended for the following recipients:
Authority (upon request)
MDR: Class I
MDR classes IIa and IIb
MDR: Class III and implantable products
Per MDCG 2022-21 Appendix I, a Periodic Safety Update Report could include the following chapter structure:
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”.
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!
In the MDCG 2021-22, you will find in Appendix I a template for a PSUR with the chapter structure described above, as well as help on what exactly is important in the content of the chapters.
Furthermore, there are several templates in Appendix II, and general information for presenting your data in Appendix III.
Even if a PMS report for Class I products does not have the same scope as a PSUR, the guidance document can also serve as a good orientation aid when preparing it.