As part of the ongoing efforts to ensure the safety and performance of medical devices, the Post-Market Surveillance (PMS) system under the European Union Medical Device Regulation (EU MDR) has become more stringent. One of the components of PMS is the periodic safety update report (PSUR), introduced in Article 86 of MDR 2017/745, which is now a cornerstone of compliance and device lifecycle management.
Interestingly, while PSURs have been mandatory for pharmaceutical products for some time, they have only recently become a requirement for medical devices under EU MDR.
What is a Periodic Safety Update Report (PSUR)?
A PSUR provides a concise analysis of PMS data to assess the benefit-risk profile, incorporating new or emerging information. By evaluating global safety data and summarising PMS findings, a PSUR ensures timely identification of risks and supports regulatory compliance.
Objectives of the PSUR
Under the EU MDR (2017/745), manufacturers are required to submit PSURs with the goal of enhancing medical devices and maximising the benefits they provide to patients.
The objectives include:
- Identification and evaluation of changes in the benefit-risk profile
- To provide information on Preventive or Corrective Actions (CAPA) according to Article 83(4).
Content of the PSUR
The key requirements of a PSUR are set out in Article 86(1) and Annex III. These include the following:
- The conclusions of the benefit-risk determination
- The main findings of the post-market clinical follow-up (PMCF)
- The volume of sales of the device, an estimate of the size and other characteristics of the population using the device, and, where practicable, the usage frequency of the device.
Which devices need a PSUR?
According to the EU MDR, the following groups of devices require a PSUR:
- MDR compliant devices
- Class IIa, IIb and III devices
- Custom-made devices falling within Class IIa, Class IIb and Class III
- Annex XVI devices falling within Class IIa, IIb and Class III certified under MDR,
- Legacy devices placed on the market before or after 26 May 2021 under Article 120(3).
Class I MDR devices and Class I legacy devices are excluded from this requirement.
Unsure which classification your device falls under? Check out our quick guide.
Frequency of PSUR submission
| Classification | Frequency | Submission |
|---|---|---|
| Class IIa | Every two years | Submit to Notified Body |
| Class IIb non-implantable devices | Annually | Submit to Notified Body |
| Class IIb implantable devices | Annually | Submit via EUDAMED to Notified Body |
| Class III | Annually | Submit via EUDAMED to Notified Body |
Reporting to competent authorities
Data collection for the PSUR should commence from the first certification date of the MDR device. Manufacturers of class III devices or implantable devices are required to submit their PSURs electronically through the European Database on Medical Devices (EUDAMED) to the Notified Body involved in the conformity assessment.
For Class IIa and IIb non-implantable devices, they are made available to the Notified Body involved in the conformity assessment and to competent authorities during surveillance activities or upon request.
Action points for manufacturers
- Ensure continuous data collection processes focusing on clinical data and adverse event reporting
- Implement a robust risk management process to assess the device’s safety and performance
- Review and update the PMS plan to ensure that PSURs meet regulatory expectations
- Maintain open communication with competent authorities to submit reports and address any identified risks promptly.
Ensuring compliance with EU MDR PSUR requirements not only helps mitigate regulatory risks but also enhances the safety of medical devices on the market. By proactively implementing a comprehensive PMS process, manufacturers can enhance device performance, improve patient outcomes, and meet EU MDR expectations.
Stay ahead of regulatory requirements—assess your PSUR process today. Contact us for a free and confidential discussion on how we can support you in meeting your MDR requirements.
