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”.

PSUR and PMS report: Regulatory background and objectives

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:

• 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.

Content of the Reports (PSUR, PMS report)

Because the safety report PSUR must be created for the higher-classed products, it contains more data compared to the PMS report.

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?

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.

Update of reports: Frequency

The frequency of report updates depends on the class:

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.

Recipients of the PSUR and PMS reports

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

Periodic Safety Update Report – Structure

Per MDCG 2022-21 Appendix I, a Periodic Safety Update Report could include the following chapter structure:

• PSUR cover page (für Klasse III und implantierbare Produkte: PSUR Web Form)
• Executive summary
• Description of the devices covered by the PSUR and their intended uses (Article 86.1)
• Grouping of the Devices
• Volume of Sales (Article 86.1)
• Size and other characteristics of the population using the device (Article 86.1)
• Post-Market Surveillance: Vigilance and CAPA information
• Post-Market Surveillance: information including general Post-Market Clinical Follow-up (PMCF) information (Annex III and Annex XIV, Part B, 6.2(a) and (f) MDR)
• Specific Post-Market Clinical Follow-up (PMCF) Information (Article 86, MDR Annex XIV, Part B, 6.2(b))
• Summary of Findings and Conclusions of the PSUR

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”.

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.