This report outlines the post-market surveillance activities related to a specific product, as detailed in the Post-Market Surveillance Plan.
1. Executive Summary
Summarize the key findings of the current PSUR and provide essential background information to make the PSUR self-contained. The executive summary should include a decisive statement on whether the benefit-risk balance has been adversely affected based on the data presented in this PSUR. This statement should be included after the conclusions section is completed.
2. Purpose and Scope of the PSUR
This PSUR pertains to [Device Name] and provides an overview of the analysis of post-market surveillance data, including a rationale and details of any preventive and corrective measures implemented.
| 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 device lifetime: |
3.1 Intended Use
Specify the intended use of the device.
3.2 Patient Population
Describe the patient population for which the device is intended.
3.3 Intended Medical Indication
Detail the medical indications for which the device is intended.
3.4 Contraindications
If applicable, state: “There are no known specific contraindications for using this device.”
3.5 Operating Principle
Provide an in-depth description of the device, including its name, models, sizes, and components, covering hardware, software, and accessories. Categorize the device type (e.g., biological artificial aortic valve) and describe its physical, chemical, and technical specifications, as well as mechanical characteristics. Mention sterilization techniques, any radioactivity aspects, and operational mechanisms. Include details about materials, particularly those in patient contact, and any medicinal substances, animal tissues, or blood components. Include diagrams and note the device class, its global market presence, and any specific configurations. Highlight novel features relevant for ongoing evaluations and address unmet medical needs. Include concise instructions for use and outline performance across different modes and device workflows.
3.6 User Profile
Describe the typical user, including required qualifications, prior training, technical expertise, and time spent using the device or software.
3.7 User Environment, Including Hardware/Software
Detail the typical environment in which the device is used, including the type of devices it operates on, whether it’s used on one or multiple devices, and the noise levels (e.g., emergency ward). Include information on required software or hardware, such as the need for a smartphone with an operating system (iOS/Android).
3.8 Characteristics of the Population Using the Device
Outline the observed use of the device across different patient groups, comparing expected and actual use, and identify any over-represented or under-represented groups.
3.9 Sales Volume
Provide accurate sales data, including any variations over the reporting period, broken down by year, size, model, and system components.
4. Summary of PMS Activities
4.1 Feedback and Complaints
4.1.1 Serious Incidents
Summarize significant incidents and their impact on risk management and the benefit-risk assessment.
4.1.2 Non-Serious Incidents and Expected Undesirable Side Effects
Summarize minor incidents and their impact on risk management and benefit-risk evaluation.
4.1.3 Proactive Feedback Collection
Summarize feedback activities, findings, implications for risk management or clinical evaluation, and any follow-up actions.
4.2 Trend Identification and Reporting
Summarize detected trends related to non-serious incidents or expected side effects, report any regulatory submissions, and detail follow-up actions.
4.3 Technical and Specialist Literature
Summarize findings from relevant technical and specialist literature, including regulations, guidance updates, product standards, and relevant journals.
4.4 Information on Similar Devices
Summarize data from publicly available sources, including complaint databases and reports related to comparable or similar devices (e.g., FDA MAUDE, MHRA, Swissmedic, implant registries).
4.5 Summary of FSCA Documentation
Summarize details on field safety corrective actions and associated documentation.
5. Key Findings from PMCF Activities
5.1 List of PMCF Studies
Summarize ongoing and planned PMCF studies.
5.2 Systematic Literature Search
Include references to the Clinical Evaluation Report or provide a summary of the literature review.
6. Information from Previous PSURs
Include relevant data from past PSURs or PMSRs (if applicable) to identify any pending actions from prior reporting periods.
7. Changes in the State of the Art
Discuss any changes in the device’s state of the art compared to the current Clinical Evaluation Report.
8. Risk Management and Benefit-Risk Assessment
Potential failure modes and associated hazards have been identified, assessed, and managed during development as per EN ISO 14971:2019. No new risks were identified from the current PMS activities, and there have been no updates to the risk management file based on safety or performance concerns.
In conclusion, the review results show that the benefit-risk profile of the device remains favorable, with the benefits continuing to outweigh the risks.
9. Planned Updates to the PMS Plan
Outline planned revisions to the PMS plan.