A medical device and an in vitro diagnostic medical device shall be qualified and classified according to its intended use and shall be subject to the analysis of criteria such as time and type of patient contact, degree of invasiveness, mode of administration, presence of potentially hazardous substances.
The correct qualification and classification of a medical device is key to determining the appropriate conformity assessment procedure and avoids the legal complications and additions to the costs associated with placing a medical device with the wrong classification on the market.