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WEEE Requirements - Medical Devices / IVDs

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instructions for use (ifu), ivd (in vitro diagnostic) devices and reagens, labeling requirements, medical devices, packaging labeling and related requirements, weee (waste electrical and electronic equipment)
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  Post Number #1  
Old 6th December 2017, 07:17 AM

Total Posts: 20
Question WEEE Requirements - Medical Devices / IVDs

Hi all,

Please can anyone advise (in laymans terms) what the requirements for WEEE are in terms of;

A) Labelling - is it required that the "crossed-out bin" symbol be present (ie either on product itself, packaging or IFU etc)?

B) IFU/Manual - does this have to contain instructions on how to dispose of WEEE products?

C) Website - are there any requirements to maintain a customer-facing WEEE website?

D) Any other commitments?

I am aware of the requirements for submitting quarterly reports of WEEE products that have been placed on the market, for example to EARN, but I am unsure of the physical product/labelling implications.

Any advice would be greatly appreciated.

Cheers :-)

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  Post Number #2  
Old 14th December 2017, 05:40 PM

Total Posts: 308
Re: WEEE Requirements - Medical Devices / IVDs

Hi fondantcookie,
Article 14 paragraph 2-5 of the WEEE directive answers most all of your questions:

"2. Member States shall ensure that users of EEE in private households are given the necessary information about:
(a) the requirement not to dispose of WEEE as unsorted municipal waste and to collect such WEEE separately;
(b) the return and collection systems available to them, encouraging the coordination of information on the available collection points irrespective of the producers or other operators which have set them up;
(c) their role in contributing to re-use, recycling and other forms of recovery of WEEE;
(d) the potential effects on the environment and human health as a result of the presence of hazardous substances in EEE;
(e) the meaning of the symbol shown in Annex IX.
3. Member States shall adopt appropriate measures so that consumers participate in the collection of WEEE and to encourage them to facilitate the process of re-use, treatment and recovery.
4. With a view to minimising the disposal of WEEE as unsorted municipal waste and to facilitating its separate collection, Member States shall ensure that producers appropriately mark preferably in accordance with the European standard EN 50419 (1) EEE placed on the market with the symbol shown in Annex IX. In exceptional cases, where this is necessary because of the size or the function of the product, the symbol shall be printed on the packaging, on the instructions for use and on the warranty of the EEE.
5. Member States may require that some or all of the information referred to in paragraphs 2, 3 and 4 shall be provided by producers and/or distributors, e.g. in the instructions for use, at the point of sale and through public awareness campaigns."

The WEEE symbol is the crossed out bin.
There is no specific requirement regarding the web site.


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