The new European regulation on medical devices requires the drafting of a periodic safety update report (PSUR), a rigorous process that cannot be improvised. MultiHealth explains the procedure and the benefits to be gained from it.
Since the entry into force of Regulation (EU) 2017/745 on medical devices (MDR), the regulatory landscape has undergone a major change, particularly in terms of post-market surveillance.
The PSUR (Periodic Safety Update Report) has become a key element of this system, requiring manufacturers to rigorously collect and analyze data on the safety and performance of their devices. Writing a PSUR requires foresight and the adoption of best practices to meet regulatory expectations while enhancing patient safety.
A document that requires regular updating
The PSUR applies to all Class IIa and higher (IIb, III, and implantable) medical devices. Its main objective is to demonstrate, at regular intervals, that the benefit/risk ratio of the device remains favorable after it has been placed on the market. This report is based on the analysis of data from the post-market surveillance (PMS) system, documented in the PMS plan. It is not a simple summary of incidents, but a structured, self-contained document (which does not require consultation of other elements to be understood) and independently evaluated by the notified body. The frequency of updates varies according to the class of the device: every two years for class IIa, and at least once a year for classes IIb and III.
PSUR structure according to MDCG recommendations
To be compliant, the PSUR must follow the structure recommended by MDCG guidance 2022-21 (1), namely:
- A cover page and a summary including administrative information, i.e., the manufacturer's contact details, device references, PSUR version, notified body, and period covered.
- An executive summary that includes a clear overview of the content, main conclusions, and status on whether or not the benefit/risk profile has changed.
- Description of devices: This should include the Unique Device Identifier (UDI-DI ), trade names, classification, indications, and marketing status. Any additions or removals of devices since the last report must be justified.
- Information relating to exposure: sales volumes (by country and in total) must be presented and the exposed population must be estimated, particularly for reusable or implantable devices.
- Performance and vigilance data: vigilance data must be grouped together: serious incidents, detected trends, safety corrective actions (FSCA (2)). Data must be coded according to IMDRF terminology (3).
Leveraging proactive data sources
The PSUR is not limited to passive vigilance. It must incorporate data from proactive monitoring, such as:
- Post-Market Clinical Follow-up (PMCF) studies,
- independent clinical databases,
- scientific literature reviews,
- real-life data: user feedback, social media, public health databases, etc.
Each source must be analyzed to detect any new risks or confirm expected performance.
List the actions taken during the past period.
The report must describe in detail the preventive and corrective actions (CAPA) taken during the period in response to safety signals or observations from clinical studies. It is crucial to include:
- the reason for the action,
- identifying the root cause,
- the status of the action (in progress, closed),
- the effectiveness of the measure, if applicable.
Each action must be linked to the clinical conclusions of the PSUR.
Draw clear and actionable conclusions
The final section of the PSUR must answer a key question: has the benefit/risk ratio changed?
The manufacturer must:
- demonstrate the validity of the data collected,
- demonstrate the potential impact of new risks,
- compare its results with similar devices (if available),
- detail the measures taken or planned in response to the findings.
Making your PSUR a strategic tool
In conclusion, the PSUR is much more than just an obligation. Writing a PSUR that complies with the MDR is not simply a matter of ticking boxes. It is a rigorous and analytical process that requires foresight in order to collect data from various sources and coordination to ensure the consistency of the document provided.
In a context of enhanced surveillance and increased traceability, a well-constructed PSUR is also a strategic asset: the PSUR reflects the manufacturer's commitment to patient safety, quality and performance monitoring of its devices, and compliance with European regulatory requirements.
1 Medical Device Coordination Group – https://health.ec.europa.eu/latest-updates/mdcg-2022-21-guidanceperiodic-safety-update-report-psur-according-regulation-eu-2017745-december-2022-12-16_en.
2 Field Safety Corrective Action.
3 International Medical Device Regulators Forum.
