Warranty of Medical Devices

JoCam

Trusted Information Resource
#1
Hi All,

Does the directive 1999/44/EC (on certain aspects of the sale of consumer goods and associated guarantees) apply to medical devices, and if so should a 2 year warranty always be offered?

Jo
 
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shimonv

Trusted Information Resource
#2
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
 

Sicco

Involved In Discussions
#3
Hi Jo
It depends - 1) 1999/44/EC is "only" directive not regulation it means each member state implement it into own regulation frame individually and there could be differences in each member state.
2) In general it depends who is your target consumer if it is private person - there should be two year warranty as minimal
if it is legal entity/company this warranty requirement could be different.
 
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