Does the company violates any regulation/standard by selling device without warranty

#1
Hello everyone,

My company manufactures medical devices which will be sold in EU countries.

Recently, my company planned to remove the warranty card for our products by saying that it is not required, as long as we provide after sales services to the customers.

I have found nothing on the requirements on warranty online. May I know if it is true that it will not violate any regulation and/or standard by doing so??

Thank you!!

Best Regards,
Clarence
 
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#4
Hello everyone,

My company manufactures medical devices which will be sold in EU countries.

Recently, my company planned to remove the warranty card for our products by saying that it is not required, as long as we provide after sales services to the customers.

I have found nothing on the requirements on warranty online. May I know if it is true that it will not violate any regulation and/or standard by doing so??

Thank you!!

Best Regards,
Clarence

I think there is a whole lot difference between a medical device and consumer goods being sold in the EU.
The MD abide by guidelines of MDD/CE. Most MD carries a shelf life (excluding software related, class-I, etc etc...), and the manufacturer is responsible for the service/compliances to the regulatory and consumers throughout the life cycle of the device (irrespective of the warranty).

aftersales service is more abiding to the regulatory than giving some warranty/guaranty. and as far I know there are no such guidelines explaining about the warranty of a Medical device. (Consumer goods guidelines are different)
 
#6
I think there is a whole lot difference between a medical device and consumer goods being sold in the EU.
The MD abide by guidelines of MDD/CE. Most MD carries a shelf life (excluding software related, class-I, etc etc...), and the manufacturer is responsible for the service/compliances to the regulatory and consumers throughout the life cycle of the device (irrespective of the warranty).

aftersales service is more abiding to the regulatory than giving some warranty/guaranty. and as far I know there are no such guidelines explaining about the warranty of a Medical device. (Consumer goods guidelines are different)
Thank you for you reply. I should consider the after-sales service of the product instead, which I believe my company has got it covered quite well.

Thank you so much!
 
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