manufacturers obligations

[kim13]

In my 16 years of experience in the field, I have noticed that the manufacturers of medical devices, are committed to providing spare parts and technological support for at least 10 years from the date the last medical device was released. Public hospitals, in their declarations for the purchase of new medical devices, require the provision of spare parts for at least 10 years.

What I am trying to find and I would like your help is the regulation or the directive, from which derive the above obligations of the manufacturers of Medical devices.

 

[itsmoked]

I can not imagine there is any such regulation in existence. It would simply be a purchasing agreement between the parties. If the manufacturer reneged they would have to compensate the original buyer. That might be something like replacing all the infusers with the new models for free or some huge discount or a cash settlement.

Keith Cress
kcress -

http://www.flaminsystems.com