(6) It is necessary to clarify that consideration of a product having a medical purpose is intrinsic to the definition of a medical device and that software in its own right can be defined as a medical device .
(6) Nepieciešams precizēt to , ka medicīnas ierīču noteikšanai būtiski ir tas, vai ierīcei ir medicīnisks nolūks, un to, ka programmatūra pati par sevi var tikt definēta kā medicīnas ierīce .