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Exemptions from Mandatory Problem Reporting

Overview​

Not every complaint or adverse event involving a medical device triggers a mandatory reporting obligation. Understanding exemptions helps companies avoid unnecessary reports while ensuring genuinely reportable events are not missed.

Events that are not reportable​

1. Events caused entirely by patient's condition​

If a patient experiences a deterioration in health that is entirely attributable to their underlying disease or condition, and the device performed exactly as specified with no malfunction or deficiency, no MPR is required.

2. Events caused entirely by user error (with no device deficiency)​

If a healthcare professional or patient used the device incorrectly in a way that was not related to any device deficiency (clear labelling, clear IFU, no design deficiency), no MPR is required. However, if the incorrect use was facilitated by a labelling deficiency or design issue, the device deficiency criterion may be met and reporting may be required.

3. Events involving devices not sold or distributed by the reporting company​

A manufacturer is not required to report events involving counterfeit versions of its devices, competitor devices, or devices that it has not placed on the market in Canada.

4. Events that do not meet the seriousness threshold​

Events that result only in minor, temporary, reversible harm — and where no serious deterioration in health occurred or could occur — are not subject to mandatory reporting. Such events should still be captured in the complaint handling system.

Borderline cases​

For borderline cases where it is uncertain whether an event is reportable, Health Canada advises:

  • When in doubt, report — there is no penalty for over-reporting
  • Document the reportability assessment in the complaint/event file regardless of the outcome

Record retention​

Even for events that are assessed as not reportable, the complaint and the reportability assessment must be documented and retained in the quality system. Health Canada may review these records during inspections.

Legislative source: Medical Devices Regulations, SOR/98-282, ss 59–64