Is minimum repair or replace guarantee period for medical devices in EU the same as consumer guarantee law of 2 years?

#1
Hi all, I'm updating our distribution contract and our new sales director who comes from a big international company is telling me they used to sell devices in the EU for a 6 month guarantee period. I know that EU consumer laws entitle buyers to a 2 year guarantee for repair or replacement. i think this applies for medical devices being sold to a distributor/reseller too. He might have been referring to an extra warranty period. Does anyone have any experience on this please?
Thanks!
Krystle
(RA in a small start-up medical device company in Malta)
 
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dgrainger

Trusted Information Resource
#2
I think you're talking about the Consumer sales and guarantees directive:
Consumer sales and guarantees directive

As it's a directive, you need to check individual county implementation.
It also applies only to good supplied to 'consumers':
"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 "​
 
#3
If you are not selling directly to consumers, why would the two-year period apply to you unless it was forced upon you by your distributors? I would go with your sales director's position. And why don't you have a lawyer reviewing the distribution agreements?
 

Mark Meer

Trusted Information Resource
#4
...I know that EU consumer laws entitle buyers to a 2 year guarantee for repair or replacement...
Wow. Please tell me there is some reasonable context for this. Otherwise, it'd be a pretty gross over-reach for the EU to start mandating sweeping product guarantees and post-market services.
 
#5
Hi all, thanks for the feedback. Yes I am referring to Consumer laws, 2 years in EU. I wanted to know what experience you all have regarding this. I gather from your feedback that a distributor is not to be considered a consumer. I asked here because the situation in Malta is that there is no medical device regulation system and no Maltese owned medical devices companies (apart from the 2 my husband and i set up). Therefore lawyers here have proven time and again that they know absolutely nothing about the industry and i wanted to ask your opinions before going to them.
Anyway, thank you for your replies!
 
#6
Hi all, thanks for the feedback. Yes I am referring to Consumer laws, 2 years in EU. I wanted to know what experience you all have regarding this. I gather from your feedback that a distributor is not to be considered a consumer. I asked here because the situation in Malta is that there is no medical device regulation system and no Maltese owned medical devices companies (apart from the 2 my husband and i set up). Therefore lawyers here have proven time and again that they know absolutely nothing about the industry and i wanted to ask your opinions before going to them.
Anyway, thank you for your replies!
Hi Krystle, for this kind of agreement, your customer/distributor will probably want it governed under the law of the destination or the U.K. or something more "neutral" than Maltese law - which they are unlikely to be familiar with. In that case your options for engaging a medical device knowledgeable lawyer open up more widely.

Good luck!
 
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