For medical devices, "expectedness" is anchored not only in user-facing labeling but critically in the Risk Management File produced under ISO 14971. An event may be known to the manufacturer through hazard analysis yet absent from the Instructions for Use — creating a bifurcated assessment that has no direct parallel in pharmaceutical vigilance.
RSI Hierarchy for Devices
Click each document layer to reveal its role in expectedness determination.
The IFU is the primary user-facing disclosure document shipped with the device. It lists known risks, contraindications, warnings, and precautions that clinicians and patients rely upon.
The RMF is the manufacturer's internal hazard analysis per ISO 14971. It catalogues foreseeable hazards, failure modes, and residual risks — many of which may never appear in user-facing labeling.
The CCSI represents the manufacturer's internal global safety position for the entire device family. It is housed within the Technical File and serves as the benchmark across all regional labeling variants.
For investigational devices undergoing clinical trials, the IB is the sole Reference Safety Information document. It determines whether an event qualifies as a Suspected Unexpected Serious Adverse Reaction (SUSAR).
Expectedness Decision Flow
Trace the path from a new safety event to its regulatory classification.
Specificity & Severity Rule
An event becomes "unexpected" when it exceeds what was documented in either dimension.
Day 0 Timeline
The clock starts when any employee first becomes aware of a potential reportable event.
Day 0: The Awareness Principle
Day 0 is triggered when any person within the manufacturer's organization first becomes aware of information suggesting a reportable event — not when the safety or regulatory team is notified. This includes sales representatives receiving a verbal complaint, clinical application specialists witnessing a malfunction during a procedure, or administrative staff opening a customer letter. The regulatory clock does not wait for internal escalation. This principle demands robust intake training across all customer-facing and back-office functions, ensuring that awareness anywhere in the company is treated as awareness by the company.