Prototype/Sample of Laboratory Device to export in EU for Testing Purposes without CE marking


We are a manufacturer of laboratory devices exporting to EU countries and offering OEM services. Currently, we seek your guidance on shipping a prototype/sample of a laboratory device to our client in the EU for testing purposes. This prototype does not bear a CE marking as it is strictly for testing and not for sale.

Could you kindly advise on the necessary documentation required for exporting such a sample/prototype to EU countries? Additionally, any steps our client must take from their end to facilitate this process would be greatly appreciated.

Thank you very much for your assistance. I look forward to your response.


Quite Involved in Discussions
First, check all the EU Directives to see if the product is required to have CE marking in the first place.

Then... it is a while since I got involved in this but if you are only making one of the piece of equipment, there used to be no requirement to have it tested and CE-marked, especially if it was for restricted use. This is what we were doing, making just one piece of equipment. The customer then asked us to make a spare, and this involved some testing (long and expensive); we tried to get the customer to avoid ordering the spare but they declined, so the order increased in value significantly and the delivery date also got moved back by a significant length of time.


Our product Falls under the 2014/30/EU, 2014/35/EU, 2011/65/EU with the inclusion of (EU) 2015/863 directive. But as The sample/prototype is for testing purposes (not for sale) it has no CE mark.

We have to export the whole unit as a sample/prototype because of client is unable to assemble it.

So, Could you kindly advise on the necessary documentation required for exporting such a sample/prototype to EU countries without CE mark?


Quite Involved in Discussions
Section 2.3 of The Blue Guide, linked above:
Placing on the market is considered not to take place where a product is:

— transferred for testing or validating pre-production units considered still in the stage of manufacture;

I would add a label onto the product that it is a test sample and not for resale
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