FAQs

means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar that Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: Diagnosis, prevention, monitoring, treatment or alleviation of disease, o Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

An organization managing a database of information on safety and/or performance related aspects of medical devices and employing staff capable of taking appropriate action on any confirmed problems.

Means a product intended specifically by its manufacturer to be used together with a medical device to enable that medical device to achieve its intended purpose.

Means written, printed or graphic matter a) Affixed to a medical device or any of its containers or wrappers. b) Information accompanying a medical device, related to identification, technical description. c) Information accompanying a medical device, related to its use, but excluding shipping documents.

Yes, it is allowed if they are made for the main medical device