(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.