Periodic Safety Update Report (PSUR)
This report describes product-specific post-market surveillance activity output as outlined in the Post-Market
Surveillance Plan.
1. Executive Summary
Describe the main results of the current PSUR and provide background information so that the PSUR “stands
alone”. Executive summary should provide a clear and bold statement declaring whether the benefit risk ratio
has been negatively impacted based on the information reported within the current PSUR. This statement
should be added after the conclusions of the PSUR have been completed.
2. Purpose and Scope of the PSUR
This Periodic Safety Update Report (PSUR) applies to [Device Name] and summarizes the results and conclusions
of the analyses of the post-market surveillance data. Furthermore, this report provides a rationale and
description of any preventive and corrective actions taken.
| General information | |
|---|---|
| Surveillance Period: | |
| PSUR Reference Number: | |
| PSUR Version Number: |
3. Device information
| This PSUR covers: | |
|---|---|
| Device name: | |
| Device model: | |
| Legal manufacturer | |
| Classification: | |
| Basic UDI: | |
| Date of the first DoC: | |
| Notified Body name and organization number: | |
| Expected lifetime of device: |
3.1 Intended Use
Add intended use.
3.2 Patient Population
Add patient population
3.3 Intended Medical Indication
Add intended medical indication
3.4 Contraindications
If none, state as follows: There are no known specific situations that contraindicate the use of this device.
3.5 Operating Principle
Offer a detailed overview of the device, encompassing its name, models, sizes, and components across
hardware, software, and accessories. Clearly categorize the device, such as a biological artificial aortic
valve, and outline its physical and chemical attributes, technical specifications, and mechanical
traits. Specify sterilization methods, radioactivity considerations, and operational principles. Detail
materials used, particularly those in contact with the patient, and any inclusion of medicinal substances,
animal tissues, or blood components. Incorporate a visual representation, and note the device's class,
global market entry, and specific product configurations. Highlight innovative features relevant to ongoing
assessments and address unmet medical needs. Provide concise step-by-step application procedures, elucidate
performance in different modes, and describe the device's workflow.
3.6 User Profile
Describe the typical user of the software. Some ideas could be: Qualifications, prior training (for your
software), technical proficiency, time spent using the software.
3.7 User Environment Including Hardware / Software
Describe the typical use environment. What sort of devices is this running on? Does the software only run on
one device or multiple devices? Is it loud and chaotic like in an emergency ward? How’s the lighting? Also,
add other software or hardware which is required by your device. Most commonly, apps require users to have a
smartphone with a compatible operating system (iOS / Android).
3.8 Characteristics of the Population using the Device
Describe the observed usage of the device in different patient populations in comparison to the expected
usage and identify the possible over-represented or under-represented patient groups.
3.9 Volume of Sales
Provide an accurate information on the number of devices sold and the possible changes on it. The data
should be presented by year to year. Provide also further information on the volume of sales in respect to
the various sizes, models and system components of the device.
4. Summary of PMS Activities
4.1 Feedbackback and Complaints
4.1.1 Serious incidents
Summarize all serious incidents and describe the influence on the risk management and the risk benefit
evaluation.
4.1.2 Non-Serious incidents and expected undesirable side effects
Summarize all non-serious incidents and describe the influence on the risk management and the risk benefit
evaluation.
4.1.3 Proactively gathered feedback
Summarize the activities and findings, any consequences on risk management and/or clinical evaluation,
including any follow-up activity.
4.2 Trend identification and reporting
Summarize information on any detected trends for non-serious incidents or expected undesirable
side-effects. Summarize the activities and findings, including the reporting to the regulatory authority and
any required follow-up activity.
4.3 Technical & Specialist Literature
Summarize information coming from specialist or technical literature, such as regulations, directives,
guidance document updates, common specifications, product standards, specialist journals, etc.
4.4 Information about Similar Devices
Summarize information coming from publicly available sources and channels for complaints or other experience
databases on equivalent/similar devices (such as FDA MAUDE, MHRA, Swissmedic, Implant Registries, etc.).
4.5 Summary of FSCA Documentation
Summarize the information on field safety and corrective actions.
5. Main findings from PMCF Activities
5.1 List of PMCF Studies
Summaries all ongoing and plannend PMCF studies.
5.2 Systematic Literature Research
Reference the CER or provide a summary of the literature search.
6. Information from previous PSURs
Information from the previous PSUR / PMSR (if available) to identify pending actions during that reporting
periods.
7. Change of the State of the Art
Describe whether there is any change of the device state of the art when compared with the evaluation from
the current Clinical Evaluation Report.
8. Risk Management & Benefit-Risk Assessment
Potential failure modes (hazards) and harms related to use of the Device Name/Group have been identified,
assessed and controlled during development according to EN ISO 14971:2019. No new hazards and harms were
identified as a result of the PMS activities conducted during the present review period, and no update of
the risk management file has been made due to safety and performance issues.In conclusion, the results referred to above demonstrate a continuous acceptability of the benefit-risk
determination of the Device Name/Group , i.e. the risks associated with use of the device are still
outweighed by the benefits of the device.
9. Required Updates to PMS Plan
Describe the plannend updates of the PMS plan.
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