B
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
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