(x)"investigational medical device" in relation to a medical device, other than in vitro diagnostic medical device, means a medical device specified in clause (zb),-(i)which does not have its predicate device as defined in clause (zm); or(ii)which is licenced under sub-rule (4) or sub-rule (6) of rule 20, sub-rule (1) of rule 25, or sub-rule (1) of rule 36 and claims for new intended use or new population or new material or major design change; and is being assessed for safety or performance or effectiveness in a clinical investigation.
