Vigilance Control
[ISO 13485 Cl, 8.2.3]
Vigilance Control Process
Vigilance is an important clause of the quality management system detailed in ISO 13485. It pertains to the systematic approach to monitoring and assessing the performance and safety of medical devices after they are available on the market.
Conversely, vigilance also involves the swift reporting and examination of any adverse events or incidents that arise from the use of a medical device. This process includes promptly informing the appropriate regulatory bodies and taking necessary corrective and preventive measures to reduce any related risks. ( This is mainly applicable in EU)
Clause 8.2.3 – Reporting to Regulatory Authorities (Vigilance Control)
This ISO clause requires that if a device presents:
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A serious safety risk, or
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Has malfunctioned or deteriorated, or
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Has caused or might cause serious injury or death,
then it must be reported to the applicable regulatory authorities in accordance with country-specific requirements
INTERNAL AUDIT TOOL
Frequently Asked Questions
What is Clause 8.2.3 about in ISO 13485:2016?
It requires medical device manufacturers to report adverse events or product issues that could result in serious injury or death to regulatory authorities, following each country’s specific requirements. This is often referred to as the vigilance system.
What are examples of reportable events?
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Patient death due to device malfunction
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Device causing serious injury (e.g., burns, infection, bleeding)
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Serious deterioration in a patient’s condition
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Product recall or field safety corrective action (FSCA)
Who is responsible for vigilance reporting in a company?
Typically, the Regulatory Affairs or Quality Assurance team. A designated person (sometimes called the “Person Responsible for Regulatory Compliance” or PRRC under EU MDR) manages this process.
What happens if you fail to comply with Clause 8.2.3?
Failure to report serious events can lead to:
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Regulatory action (warning letters, fines, product seizures)
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Suspension of CE Certificate by Notified Bodies
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Damage to company reputation and loss of market access
Does this apply to distributors or importers too?
Under EU MDR, yes — importers and distributors also have vigilance obligations, like forwarding complaints to the manufacturer and cooperating in field safety actions.