Post-Market Surveillance and Ongoing Compliance
Once your medical device is approved and on the market, maintaining regulatory compliance is an ongoing responsibility. Post-market surveillance (PMS) ensures that your product continues to meet safety and performance standards throughout its lifecycle. This guide walks you through the key stages of post-market surveillance, vigilance reporting, and ongoing compliance in the EU and US, with helpful links to key regulations.
Step 1:
Understand the Requirements for Post-Market Surveillance (PMS)
Post-market surveillance (PMS) refers to the proactive collection, analysis, and reporting of data on the performance and safety of your device after it has been introduced to the market. PMS is mandatory under both the EU MDR/IVDR and FDA regulations in the US.
In the EU:
PMS is required for all medical devices. You must implement a PMS plan that continuously monitors the safety and performance of your device. The plan should be proportionate to the risk class of the device.
Key elements include:
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Ongoing collection of data related to device performance and safety.
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Analysis of this data to identify any potential risks or issues.
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Continuous updates to your technical documentation based on the results of post-market surveillance.
In the US:
FDA requires manufacturers of certain high-risk devices to conduct post-market surveillance under Section 522 of the FD&C Act. Post-market surveillance is a systematic collection and analysis of data to detect any unforeseen risks or adverse effects once the device is in use.
More information:
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FDA Post-Market Surveillance Requirements
Step 2:
Develop a Post-Market Surveillance (PMS) Plan
Developing a comprehensive PMS plan is crucial to ongoing compliance. The plan should be tailored to the risk class of the device and aligned with the regulatory requirements in the market where the device is sold.
Key Components of a PMS Plan:
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Data Collection: Define the sources from which data will be collected (e.g., user feedback, incident reports, clinical data).
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Risk Assessment: Continuously assess risks and implement measures to minimize them.
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Performance Evaluation: Monitor device effectiveness and ensure it continues to meet its intended use.
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Reporting Mechanisms: Establish clear procedures for reporting adverse events and incidents to the relevant regulatory authorities.
Useful links:
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FDA PMS Requirements
Step 3:
Implement Vigilance Reporting and Incident Management
Vigilance reporting is essential for identifying and mitigating risks associated with your device. Manufacturers must report serious incidents, such as device malfunctions or adverse effects, to the relevant authorities.
In the EU:
Vigilance reporting is a key component of PMS under MDR and IVDR. Manufacturers are required to report serious incidents to the Competent Authorities within a defined timeframe. Incidents should be reported through the EUDAMED database.
Reporting timelines:
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Serious Incidents: Report within 10 days of becoming aware of the issue.
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Field Safety Corrective Actions (FSCAs): Notify authorities before or at the time of implementing the action.
In the US:
The FDA’s Medical Device Reporting (MDR) program requires manufacturers to report device-related adverse events and malfunctions. Reports must be submitted to the FDA through the MedWatch system.
Reporting timelines:
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Serious Injuries or Deaths: Report within 30 days.
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Device Malfunctions: Report within 30 days if the malfunction could lead to serious injuries or deaths.
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FDA Medical Device Reporting
Step 4:
Periodic Safety Update Report (PSUR)
For higher-risk devices (Class IIa, IIb, and III in the EU), manufacturers must create and submit Periodic Safety Update Reports (PSUR) to demonstrate ongoing device safety and performance.
In the EU:
Under MDR, Class IIa, IIb, and III devices require regular PSUR submissions to Competent Authorities and Notified Bodies. These reports summarize the results of your post-market surveillance activities, including risk-benefit analysis, and suggest improvements if necessary.
Submission timelines:
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Class III and IIb devices: PSUR must be updated annually.
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Class IIa devices: PSUR must be updated every two years.
Step 5:
Maintain and Update Technical Documentation
Ongoing post-market surveillance data and vigilance reporting results must be reflected in your technical documentation. Regular updates to your risk management, clinical evaluation, and technical documentation are necessary to remain compliant with regulations.
In the EU:
Update your risk management and clinical evaluation reports based on PMS findings. Incorporate new data from vigilance reports and PSURs into your technical documentation.
More information:
In the US:
Continuously monitor and update technical documentation, incorporating PMS findings and any corrective actions taken to address adverse events or risks.
Step 6:
Conduct Post-Market Clinical Follow-up (PMCF) Studies
For some high-risk devices, post-market clinical follow-up (PMCF) studies are required to collect long-term data on device performance and safety.
In the EU:
PMCF is part of the overall post-market surveillance process for higher-risk devices. Manufacturers must actively collect and analyze clinical data to verify the continued safety and effectiveness of the device.
More information:
In the US:
The FDA may require additional post-approval studies for certain Class III devices to monitor long-term performance.
More information:
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FDA Post-Approval Studies
Step 7:
Manage Field Safety Corrective Actions (FSCA)
If a device presents an unacceptable risk, manufacturers must take corrective actions to ensure safety. This may include issuing a Field Safety Corrective Action (FSCA), such as device recalls or updates.
In the EU:
FSCAs must be reported to the Competent Authorities, and users should be informed about the corrective actions.
More information:
In the US:
The FDA requires reporting and actions for recalls and corrective measures under the Medical Device Recall process.
More information:
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FDA Medical Device Recalls
Helpful Links:
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FDA Post-Market Surveillance Overview
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FDA Medical Device Reporting (MDR)
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FDA Post-Approval Studies