Section 3
ActIn forceProvision 3 of 80
Section 3
(1)
A medical device shall be classified by an establishment based on the level of risk it poses, its intended use and the vulnerability of the human body in accordance with the prescribed manner.
Medical Device 13
(2)
In the event of any dispute between an establishment and a conformity assessment body over a classification of a medical device, the matter shall be referred to the Authority, in the manner and within such period as may be specified by the Authority, for its decision.