Handling complaints about medical devices (GUI-0065): Glossary
These definitions explain how terms are used in this document. If there is a conflict with a definition in the Food and Drugs Act or Medical Devices Regulations, the definition in the Act or Regulations prevails.
Abnormal use: An act, or omission of an act, by the user of a medical device as a result of conduct that is beyond any reasonable means of risk control by the manufacturer. Foreseeable misuse, that is warned against in the instructions for use, is considered abnormal use if all other reasonable means of risk control have been exhausted. This would include intentional use for non-approved purpose, such as off-label use.
Complaint: Any written, electronic or oral communication that alleges or implies deficiencies concerning the identity, quality, durability, reliability, safety, effectiveness or performance of a medical device that has been released for distribution or sale as per the requirements of the regulations. Complaints include reports of incidents or problems involving medical devices or associated labelling.
Control number: A unique series of letters, numbers or symbols, or any combination of these:
- that is assigned to a medical device by the manufacturer and
- from which a history of the manufacture, packaging, labelling and distribution of a lot or batch of the device can be determined
Corrective action: Action to eliminate the cause of a detected nonconformity or other undesirable situation.
- There can be more than 1 cause for a nonconformity.
Correction: Action to eliminate a detected nonconformity, such as repairing, modifying, adjusting, relabelling or inspecting (including patient monitoring) a device without its physical removal to some other location. Thus, a correction can be:
- made with a corrective action
- a rework or re-grade (ISO 13485:2016)
- a recall to address nonconforming devices in distribution
Note: A nonconformity may include a problem or malfunction with the device.
Distributor: A person, other than a manufacturer, importer or retailer, who sells a medical device in Canada for the purpose of resale or use, other than for personal use. A person outside of Canada selling medical devices into Canada is also considered a distributor.
Harm: Injury or damage to the health of people, or damage to property or the environment. (ISO 14971:2019)
Hazard: Potential source of harm. (ISO 14971:2019)
Hazardous situation: Circumstance in which people, property or the environment is/are exposed to one or more hazards. (ISO 14971:2019)
Health care facility: A facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that is responsible for the activities carried out in those facilities. (section 1, Medical Devices Regulations)
Importer: A person in Canada, other than the manufacturer of a medical device, who is responsible for the medical device being brought into Canada for sale.
Manufacturer: A person who sells a medical device under their own name, or under a trademark, design, trade name or other name or mark owned or controlled by the person, and who is responsible for designing, manufacturing, assembling, processing, labelling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that person or on their behalf. (section 1, Medical Devices Regulations)
Medical device: A device within the meaning of the Act but does not include any device that is intended for use in relation to animals. (section 1, Medical Devices Regulations)
Nonconformity: Non-fulfillment of a requirement. (ISO 13485:2003)
Person: Includes a partnership and an association. (section 1, Medical Devices Regulations)
Preventive action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation.
- There can be more than 1 cause for a potential nonconformity.
- Preventive action is taken to prevent occurrence, whereas corrective action is taken to prevent recurrence.
Private-label manufacturer: A person who sells a private label medical device under their own name or trademark.
Recall: means
- recall ordered by the Minister under section 21.3 of the Act; or
- any action taken by a manufacturer, importer or distributor of a medical device, after the device has been sold, to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device
- may present a risk of injury to health,
- may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety, or
- may not meet the requirements of the Act or these Regulations
(section 1, Medical Devices Regulations)
Record: A document that states the results achieved or provides evidence of activities performed. (ISO 9000:2008)
- Records can be used to track the history of a part or service and to provide evidence of verification and preventive and corrective actions.
Residual risk: Risk remaining after risk control measures have been implemented. (ISO 14971:2019)
Risk: Combination of the probability of occurrence of harm and the severity of that harm. (ISO 14971:2019)
Risk analysis: Systematic use of available information to identify hazards and to estimate the risk. (ISO 14971:2019)
Risk assessment: Overall process comprising a risk analysis and a risk evaluation. (ISO 14971:2019)
Risk control: Process in which decisions are made and measures implemented by which risks are reduced to, or maintained within specified levels. (ISO 14971:2019)
Risk evaluation: Process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk. (ISO 14971:2019)
Risk management: Systematic application of management policies, procedures and practices to analysing, evaluating and monitoring risk. (ISO 14971:2019)
Sell: Includes
- offer for sale, expose for sale, have in possession for sale — or distribute to one or more persons, whether or not the distribution is made for consideration, and
- lease, offer for lease, expose for lease or have in possession for lease
(section 2, Food and Drugs Act)
Serious deterioration in the state of health: A life-threatening disease, disorder or abnormal physical state, the permanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage.
(section 1, Medical Devices Regulations)
Also includes a serious public health threat, which is any incident type, that results in:
- imminent risk of death
- serious deterioration in health or
- serious illness that requires prompt remedial action
Significant change: A change that could reasonably be expected to affect the safety or effectiveness of a medical device. It includes a change to any of the following:
- the manufacturing process, facility or equipment
- the manufacturing quality control procedures
- includes the methods, tests or procedures used to control the quality, purity and sterility of the device or of the materials used in its manufacture
- the design of the device
- includes its performance characteristics, principles of operation and specifications of materials, energy source, software or accessories
- the intended use of the device
- includes any new or extended use, any addition or deletion of a contra-indication for the device and any change to the period used to establish its expiry date
(section 1, Medical Devices Regulations)
User error: Act, or omission of an act, that has a different result to that intended by the manufacturer or expected by the user. Includes slips, lapses, mistakes and reasonably foreseeable misuse.