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Mandatory Problem Reporting — What Must Be Reported

The reporting obligation​

Under ss 59–64 of the Medical Devices Regulations, manufacturers, importers, and distributors must submit a Mandatory Problem Report (MPR) to Health Canada when they become aware of information suggesting that:

  1. A device they sell, import, or distribute was involved in a death or serious deterioration in the health of a patient, user, or another person; and
  2. The device's malfunction or deterioration could cause or contribute to a similar event if it were to recur.

Both conditions must be met for a mandatory reporting obligation to arise.

Serious deterioration in health​

"Serious deterioration in health" includes:

  • Life-threatening illness or injury
  • Permanent impairment of a body function or permanent damage to a body structure
  • Hospitalisation or prolonged hospitalisation
  • Necessity for medical or surgical intervention to prevent one of the above
  • Foetal distress, foetal death, or congenital abnormality

The "malfunction or deterioration" condition​

The malfunction or deterioration of the device must be a contributing or potential contributing factor to the death or serious deterioration. This includes:

  • Device failure or malfunction
  • Inadequate labelling or instructions (where the inadequacy contributed to the event)
  • Incorrect use facilitated by design deficiencies
  • A device deficiency that, even if it has not yet caused harm, could cause harm if the situation recurred

What is NOT reportable​

The following typically do not require an MPR:

  • Events caused entirely by the patient's underlying condition with no device contribution
  • Events caused entirely by user error unrelated to any device deficiency
  • Minor complaints with no patient safety implications
  • Events where the device performed exactly as specified, but the indication was wrong

When in doubt, err on the side of reporting — Health Canada prefers over-reporting to under-reporting.

Anticipating vs. unexpected events​

There is a distinction between:

  • Unexpected events (not described in the device's labelling as a known risk) → 10-day reporting requirement
  • Expected events (described in the device's labelling as a known, acceptable risk) → 30-day reporting requirement

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