Risk classification guide for medical device establishment inspections: Glossary

Version: 3

Date issued: December 9, 2022

Replaces: Risk classification guide for medical device establishment inspections, version 2 (January 31, 2020)

Disclaimer: This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.

Departure from an approved instruction or established standard (ICH Q7)
Injury or damage to the health of people, or damage to property or the environment (ISO 14971:2019)
Potential source of harm (ISO 14971:2019)
Hazardous situation
Circumstances in which people, property or the environment is/are exposed to 1 or more hazards (ISO 14971:2019)
Observation (medical devices)

A deviation, deficiency or failure to comply with the Food and Drugs Act or the Medical Devices Regulations that an inspector:

  • sees during an inspection of a medical device establishment
  • confirms in an inspection report given to the establishment

Consult Introduction for more information about how observations are classified by risk

Includes a partnership and an association (s. 1, MDR)
Combination of the probability of occurrence of harm and the severity of that harm (ISO 14971:2019)
Measure of the possible consequence of a hazard (ISO 14971:2019)

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