International Sales Legal/Regulatory Gray Area?

I

IHeartRegs

#1
Hi, all. I'm a frequent lurker and know this is a good site to gain a broad perspective on issues. Hoping for that with this one!

If a contract for a medical device (not yet FDA registered or ISO certified) specifies a certain percentage of down payment for international sales (without delivery of product) 30-45 days before shipment of product (at which time the remainder would be paid, and would not occur before the CE mark is obtained), can the down payment be legally accepted before the CE mark is obtained?

Regardless of the answer, would you mind sharing the criteria/standard/precedent for the decision? Or, if you can't answer, even being pointed in the right direction to research the applicable laws/regulations myself would be enormously helpful. We're trying to educate ourselves.

Looking forward to some help/direction.:) Thanks!
 
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Wes Bucey

Prophet of Profit
#2
Re: Legal/Regulatory Gray Area?

Hi, all. I'm a frequent lurker and know this is a good site to gain a broad perspective on issues. Hoping for that with this one!

If a contract for a medical device (not yet FDA registered or ISO certified) specifies a certain percentage of down payment for international sales (without delivery of product) 30-45 days before shipment of product (at which time the remainder would be paid, and would not occur before the CE mark is obtained), can the down payment be legally accepted before the CE mark is obtained?

Regardless of the answer, would you mind sharing the criteria/standard/precedent for the decision? Or, if you can't answer, even being pointed in the right direction to research the applicable laws/regulations myself would be enormously helpful. We're trying to educate ourselves.

Looking forward to some help/direction.:) Thanks!
My "weasel mind" says YES - I would consider it the same as prepayment in full for a custom product, subject to refund if the product does NOT achieve CE status.

The governing criterion is the refund if CE not achieved. Obviously, the product is NOT delivered until CE status achieved.
 

CharlieUK

Quite Involved in Discussions
#4
I don't see any issue with part payment

A product must be CE marked before it is "placed on the market" or "put into service" and neither of these have been done.

This sounds like purely a contractual requirement where intent to buy is confirmed with part payment and transfer of ownership has not occurred.

Charlie
 
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