New to WEEE Directive - Selling a medical device directly to a professional end-user

tebusse

Involved In Discussions
#1
Greetings,

I am new to the requirements that fall under the WEEE Directive and request some assistance please.

Our medical device falls within the scope of the directive and we would sell our device directly to a professional end-user within a Member State. Would our authorized be responsible for registering us with the applicable national registry for each applicable Member State? Also, would we be required to register since we request all devices to be returned to us in the United States upon end-of-life (nothing will be recycled or disposed of in the EU)?

Thank you in advance, Tonia
 
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myusoffice

First Time Right...
#2
Re: New to WEEE Directive - Selling a medical device directly to a professional end-u

HI Tonia,

The answer to your first part of the question is Yes. Please see below:

Unfortunately, I can't answer the 2 part of your question. I am hoping someone with direct knowledge, similar your situation can answer.

According to Article 3(1)(f)(iv), in cases where the manufacturer or seller established in a nonEU
country sells EEE directly to an end-user located in a Member State by means of distance
communication, this manufacturer or seller is considered to be the producer of that EEE and must
comply with the requirements of the Directive (i.e. he has to be registered in the national registry of
each Member State where he sells, to fulfil take-back obligations, to report on the quantities placed
on the market of each Member State).
However, if a manufacturer or seller established in a non-EU country sells EEE to a professional seller
in a Member State then the latter meets the definition of producer under Article 3(1)(f)(iii) and
he/she is the one to comply with the requirements of the Directive.
 
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