Objectives

Identification and evaluation of changes of the benefit-risk profile
The main objective of a PSUR us to present a summary of the results and conclusions of the analysis of PMS data, thus allowing the reporting of any possible changes to the benefit-risk profile of the devices.

Information on Corrective or Preventive Actions (CAPA)
The PSUR provides information about Corrective Actions or Preventive Actions. A summary of CAPA can be made available to the Competent Authorities either through the PSUR or through a specific report. All safety related CAPA should be part of the PSUR.

Content

General Aspects
The PSUR should be generated as a stand-alone document that can be assessed independently from the supporting documentation and shall provide a general overview of all PMS activities and data.

Specific Aspects
In accordance with Article 86(1) of the MDR, the PSUR should provide:
1. The conclusions of the benefit-risk determination
2. The main findings of the PMCF
3. The volume of sales of the device and an estimation of the population using the device.

Scope

Devices within the scope of PSUR requirement
For class III, class IIb and class IIa devices, the PSUR is required for each device or for each group of devices.

Devices outside the scope of PSUR requirement
Class I MDR devices and class I legacy devices

Duration

Device lifetime
A PSUR is required throughout the lifetime of the device.

The data collection period should start at the device MDR certification date. If the device is not MDR-certified, the data collection period starts at the MDR Date of Application (26 May 2021)

End of obligation to update the PSUR
When the last manufactured device has been placed on the market and the intended lifetime of that device has been achieved, a PSUR is no longer required to be updated.