Hi Jo,
Definition of consumer from directive 1999/44/EC :
"consumer: shall mean any natural person who, in the contracts covered by this Directive, is acting for purposes which are not related to his trade, business or profession;"
The word "Consumer" is not mentioned anywhere in the medical device directive.
I have not heard of a notified body applying directive 1999/44/EC to medical devices.
It seems to me that the regulator did not intend for medical devices to be treated as consumer good. Also, most all medical devices are intended for healthcare professionals, not consumers.
Shimon