Manufacturers of class IIa, class IIb, and class III medical devices have to prepare a Period Safety Update Report (PSUR) for each device or group of device. Manufacturers of class I medical devices do not have to prepare a PSUR, but a PMS report instead. With article 86, the Medical Devices Regulation (MDR) introduced this requirement.
In December 2022, the Medical Device Coordination Group (MDCD) published a Guidance to assist manufacturers in implementing the PSUR requirements. Specifically, this Guidance applies to medical devices certified under MDR as well as to legacy devices. The Guidance also includes templates for the PSUR, EUDAMED PSUR Web Form, and the presentation of data in Annex I – V.
PSUR objectives: benefit-risk analysis and corrective actions
The main objective of this report is to present a summary of the data gained through post market surveillance. Data can refer to a specific device or a devices’ group and have to allow the identification of any safety and performance concerns. After identifying any concerns, a re-evaluation of the benefit-risk profile and the state of art of the device should follow.
In addition, the PSUR should also include information about Corrective Action(s) or Preventive Action(s) (CAPA). Typically, CAPA refers to:
- Devices already placed on the EU market.
- Issues related to product safety, performance or quality.
- Any suspensions of marketing of devices not associated with commercial decisions.
- Evaluation of benefits and risks identified through post-market activities.
Article 86 of the MDR states that the PSUR is part of the Technical Documentation. Principally, the PSUR should be a stand-alone document, easy to find and clearly presented. In particular, the PSUR should include a summary of the results and conclusions of all post-market surveillance activities and the data collected and analysed. The data are based on the PMS plan.
Mainly, the report should include:
- Conclusions of the benefit-risk determination.
- Main findings of the post-market clinical follow-up (PMCF).
- Volume of sales, estimated characteristics of the population using the device, and frequency of use, when applicable.
Scope and duration of the PSUR requirement
Both MDR compliant devices and legacy devices should have a PSUR, required throughout the lifetime of the device. The manufacturer indicates the lifetime of the device, during which a device is expected to remain safe and effective. The manufacturer should draw up a report per device and, where relevant, for a category or group of devices. When a report covers one device, this device should be associated with one Basic UDI-DI. On the other hand, one PSUR can cover multiple Basic UDI-DIs (or device families) when the manufacturer provides a proper justification.
It is no longer necessary to update the report when the manufacturer places the last device on the market and its intended lifetime has been achieved.
General aspects for all PSURs and specific aspects for EUDAMED
Among others, all PSURs should meet the following requirements:
- In the case of one PSUR for a group of devices, the manufacturer should assign a “leading device” which drives the schedule.
- In the update of the report, the manufacturer can amend a device grouping by removing or adding devices except for the “leading device”.
- When there are changes in the “leading devices”, the manufacturer should issue a new report.
- Grouping devices within one PSUR is only possible when the same Notified Body assesses the devices.
When submitting the device in EUDAMED, the manufacturer should observe, among other things:
- The PSUR should include references to at least one Basic UDI-DI of class III or implantable devices. It is possible to add several Basic UDI-DIs in case of a grouping of devices.
- Every class III or implantable device should have at least one linked PSUR.
- The manufacturer should use the EUDAMED web interface to capture the Basic UDI-DIs of class III or implantable devices belonging to that group.
Notably, manufacturers of legacy devices should not submit the PSUR in EUDAMED. However, they should make it available upon request to the Competent Authorities and the Notified Body.
PSUR preparation and issuance
As specified in the Regulation, the manufacturer is responsible for preparing and updating the PSURs and including them in the Technical Documentation. Moreover, the manufacturer should either submit the PSUR to the Notified Body via EUDAMED or make it available to the
When a legacy device receives a certification under MDR, the initial PSUR schedule can continue. When a significant change occurs, the device is considered a new device.
Manufacturers of legacy devices should have started the collection of data in May 2021, date of MDR application. Afterwards, they have either one or two years to finalise the report, depending on the device class. For class IIa devices, the first availability of the report is May 2023, whereas for devices from other classes, the PSUR should have been ready by May 2022.
Here below a Summary Table MDR and Legacy devices:
Find all relevant Guidance documents in our Library of Document.