Medical Devices Regulations — 1
ull information as to the procedures recommended for achieving the optimum performance of the device, and includes cautions, warnings, contra-indications and possible adverse effects. ( mode d’emploi ) dispenser means a person who is a member of a professional governing body and who is entitled, by virtue of their membership in that body, to manufacture or adapt a medical device in accordance with a health care professional’s written directions in order to meet the specific requirements of a patient. ( préparateur ) General Council Decision has the meaning assigned by subsection 30(6) of the Act. ( décision du Conseil général ) genetic testing means the analysis of DNA, RNA or chromosomes for purposes such as the prediction of disease or vertical transmission risks, or monitoring, diagnosis or prognosis. ( test génétique ) health care facility means a facility that provides diagnostic or therapeutic services to patients. It includes a group of such facilities that report to one common management that has responsibility for the activities carried out in those facilities. ( établissement de santé ) health care professional means a person who is entitled under the laws of a province to provide health services in the province. ( professionnel de la santé ) identifier means a unique series of letters or numbers or any combination of these or a bar code that is assigned to a medical device by the manufacturer and that identifies it and distinguishes it from similar devices. ( identificateur ) implant means a medical device that is listed in Schedule 2. ( implant ) invasive device means a medical device that is intended to come into contact with the surface of the eye or penetrate the body, either through a body orifice or through the body surface. ( instrument effractif ) in vitro diagnostic device or IVDD means a medical device that is intended to be used in vitro for the examination of specimens taken from the body. ( instrument diagnostique in vitro ou IDIV ) manufacturer means 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. ( fabricant ) medical device means a device within the meaning of the Act, but does not include any device that is intended for use in relation to animals. ( instrument médical ) medical device family means a group of medical devices that are made by the same manufacturer, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that have the same intended use. ( famille d’instruments ) medical device group means a medical device comprising a collection of medical devices, such as a procedure pack or tray, that is sold under a single name. ( ensemble d’instruments ) medical device group family means a collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group. ( famille d’ensembles d’instruments ) name of the device , in respect of a medical device, includes any information necessary for the user to identify the device and to distinguish it from similar devices. ( nom de l’instrument ) near patient in vitro diagnostic device or near patient IVDD means an in vitro diagnostic device that is intended for use outside a laboratory, for testing at home or at the point of care, such as a pharmacy, a health care professional’s office or the bedside. ( instrument diagnostique clinique in vitro ) objective evidence means information that can be proved true, based on facts obtained through observation, measurement, testing or other means, as set out in the definit