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Label medical devices in accordance with the labeling regulations, 21 CFR 801 or 21 CFR 809; Report adverse events of medical device as identified by the user, manufacturer and/or distributor” Examples of Class I devices include tongue depressors, arm slings, and manual stethoscopes. Medical devices can also be used to change the structure or function of the body (for example… A medical device classification system is therefore needed, in order to channel medical devices into the proper conformity assessment route. Devices for self-testing - Devices for self-testing form a special IVD group. Under the Directive, accessories are treated as separate in vitro diagnostic medical devices. The goal of the Regulations is to ensure that medical devices distributed in Canada are safe and effective and meet quality standards. Class II Medical Devices A medical device is an instrument, apparatus, machine or related object used to diagnose, cure, treat, or prevent diseases in people or animals. Accessories to medical devices are classified separately to the device, excluding accessories to active implantable devices. Examples of permitted listings . Products classified as Class I medical devices that meet all prescribed safety and effectiveness requirements, do not require a prescription, are not otherwise prohibited, and are appropriately described and labelled, such as:

Accessories are designed specifically for a device, and may include consumables, parts, add-ons, and other components for use in conjunction with, or for upgrade, replacement and repair of parts of a medical device. The Medical Devices Regulations set out the requirements governing the sale, importation and advertisement of medical devices. This help page covers medical devices and accessories. In order to ensure that conformity assessment under the Medical Device Directive functions effectively from January 1995, manufacturers should be able to know as early as possible in which class their product is. These Regulations were published in Canada Gazette II on May 27, 1998, and implementation began on July 1, 1998. These IVDs are intended by the manufacturer to be used by laypersons in a home environment, for example pregnancy tests.