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Glossary Term
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Individual Case Safety Report (ICSR)

Definition

An Individual Case Safety Report (ICSR) is a standardized document used to report information about a single case of an adverse event, product quality complaint, or other safety concern associated with a medical product, such as a medical device, drug, or combination product. ICSRs are critical for regulatory compliance and safety monitoring.

Relevance to the MedTech Industry

ICSRs play a vital role in post-market surveillance by ensuring that adverse events and safety concerns are documented, reported, and analyzed. These reports enable manufacturers and regulatory authorities to identify trends, assess risks, and implement corrective actions to protect patients and users. They are integral to maintaining compliance with global regulatory frameworks, such as FDA’s Medical Device Reporting (MDR) requirements or EU MDR vigilance reporting.

Additional Information & Related Terms

Key Components of an ICSR

  1. Reporter Information

    • Includes details about the individual submitting the report, such as a healthcare professional, manufacturer, or user.

  2. Patient Information

    • Contains anonymized demographic details, such as age, sex, and medical history relevant to the case.

  3. Device Information

    • Identifies the medical device, including its name, model, serial number, and lot or batch number.

  4. Adverse Event Description

    • Provides a narrative or structured description of the adverse event, including its severity, outcome, and relationship to the device.

  5. Causality Assessment

    • An evaluation of the likelihood that the device contributed to the adverse event.

  6. Corrective Actions

    • Details any actions taken in response to the event, such as device recalls, design changes, or user training updates.


Related Terms

  • Adverse Event (AE): A key trigger for generating an ICSR, detailing incidents involving device-related harm.

  • Post-Market Surveillance (PMS): ICSRs are integral to ongoing safety monitoring under PMS frameworks.

  • Corrective and Preventive Actions (CAPA): Actions often initiated based on trends identified in ICSRs.

  • Medical Device Reporting (MDR): FDA's system for mandatory submission of ICSRs for adverse events involving medical devices.

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