Options to export into the EU without a CE Mark (?)

B

barbaram

#1
I’m hoping the Elsmar universe can help me understand something regarding exporting requirement of product out of the US into the EU.

We are a US Manufacturer and distributor of medical devices (510(k)). The majority of our products are CE Marked, but for various reasons there are a couple of products that are do not carry the CE Mark. One product in particular was packaged and co-branded specifically for a global distribution partner who happens to be headquartered in the UK. This product does not have a CE Mark as it was deemed to not be necessary for a particular distribution pipeline to their Middle East customer- the important clearance for this customer was US 510k clearance (which this product does have).

Initially, we were to ship the product directly to the Middle East customer from the US, but the UK Distributor would now like us to ship the product directly to them in the UK for them to distribute to their Middle East customer. This product is not for EU distribution. Can we ship a non-CE Marked product into the EU/UK if the product is not intended for EU distribution? If so, does anyone know of specific labeling requirements to satisfy EU Customs officials?

Thank you in advance for your assistance.

Best, Barb
 
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somashekar

Staff member
Super Moderator
#2
(h) ‘placing on the market’ means the first making available in return
for payment or free of charge of a device other than a device
intended for clinical investigation, with a view to distribution
and/or use on the Community market, regardless of whether it is
new or fully refurbished;

(i) ‘putting into service’ means the stage at which a device has been
made available to the final user as being ready for use on the
Community market for the first time for its intended purpose;

Article 2
Placing on the market and putting into service
Member States shall take all necessary steps to ensure that devices may
be placed on the market and/or put into service only if they comply with
the requirements laid down in this Directive when duly supplied and
properly installed, maintained and used in accordance with their
intended purpose.
Above is from MDD definition and Article 2

So your UK distributor can take a call on this as it is he who is "NOT putting the device into the market in the EU"

Ask him to get the necessary clearences.
 
B

barbaram

#3
Thanks, Somashekar! My Notified Body did get back to me and gave the same assessment on the MDD but without the added suggestion on customs and the distributor- I appreciate your feedback!
 

somashekar

Staff member
Super Moderator
#4
Thanks, Somashekar! My Notified Body did get back to me and gave the same assessment on the MDD but without the added suggestion on customs and the distributor- I appreciate your feedback!
Hi Barb...
They would not because it is not their domine. Customs do not get into CE stuff, but when they doubt, they call upon the competent authorities. Your UK distributor will have to work with the customs and his import clearing authorities prior to your shipping and you get the green to ship out.
 
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