Situations where the device should not be used because the risk of use clearly outweighs any reasonably foreseeable benefits.
Control mechanism:
The means by which the action of a device is directed or the output of a device is regulated.
Design specifications:
A set of device characteristics that clearly state the technical and performance criteria that a medical device meets. They must be measurable and/or verifiable. For example, the design specifications of a medical device can describe a device’s:
properties, such as dimensions, weight/mass, form/configuration or materials
performance (or functional) characteristics, such as accuracy, strength, force, flexibility or energy source/output level
Facility:
A site that’s involved in the manufacture or design and manufacture of a medical device.
Operating principles:
The means by which a device produces or brings about an intended or appropriate effect. They are the means whereby a device is able to have a certain influence on a person or its surroundings.
Precautions:
Information that alerts the user to exercise special care for the safe and effective use of the device.
Recall:
For a medical device that has been sold, any action taken by the manufacturer, importer or distributor of the device 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:
be hazardous to health
fail to conform to any claim made by the manufacturer or importer about its effectiveness, benefits, performance characteristics or safety or
not meet the requirements of the Food and Drugs Act or the Medical Devices Regulations
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, including 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, including its performance characteristics, principles of operation, specifications of materials, energy source, software, or accessories
the intended use of the device, including any new or extended use, any addition or deletion of a contraindication for the device, and any change to the period used to establish its expiry date
Surgically invasive device:
An invasive device that is intended to enter the body through an artificially created opening that provides access to body structures and fluids.
Validation:
Confirmation, through objective evidence that the requirements for a specific intended use or application have been fulfilled (for example, clinical evaluations or performance evaluations). Validation demonstrates that the clinical performance of a device is acceptable.
Verification:
Confirmation through provision of objective evidence that specified requirements (for example, comparing a new design specification with a similar proven design) have been fulfilled. Verification ensures a device performs as intended.
Warning:
Describes serious adverse reactions and potential safety hazards that can occur in the proper use, or misuse, of a device, along with the consequent limitations in use and mitigating steps to take if they occur.
