Medical Devices and the WEEE (Waste Electrical and Electronic Equipment) Directive

ISO 13485 - Medical

Quite Involved in Discussions
#1
As a non EU medical device company do we need to comply with the WEEE directive for our electrical device?

Is this something that our EU Authorised rep would help with?
 

Dr. L. Ramakrishnan

Forum Moderator
Moderator
#2
Re: Medical Devices and the WEEE (Waste Electrical and Electronic Equipment) Directiv

Hi,

End-of-life (EOL) Medical devices have been included in the EU WEEE directive (Category 8); please go through the definition of "Producer" and "Distributor" which will give you an idea of your responsibility with respect to EOL product that you export to EU. You may like to download the EU WEEE directive for your reference (e.g. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:037:0024:0038:EN:PDF). Please note that the interpretation/application of the directive may vary from country to country. It is always better to check with your contacts in the country to which you would be exporting the product on the finer aspects of your responsibility to EOL products. You may also have to check for new notifications by EU on WEEE regularly to see if there is any additional responsibility because of the new notification.

By the way, unlike consumer electronics products, Medical Devices have a long life and generally go for reuse /re-manufacture / repair many times before finally disposed.

With kind regards,

Ramakrishnan
 

somashekar

Super Moderator
Staff member
Super Moderator
#3
Re: Medical Devices and the WEEE (Waste Electrical and Electronic Equipment) Directiv

Hi,

End-of-life (EOL) Medical devices have been included in the EU WEEE directive (Category 8); please go through the definition of "Producer" and "Distributor" which will give you an idea of your responsibility with respect to EOL product that you export to EU. You may like to download the EU WEEE directive for your reference (e.g. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:037:0024:0038:EN:PDF). Please note that the interpretation/application of the directive may vary from country to country. It is always better to check with your contacts in the country to which you would be exporting the product on the finer aspects of your responsibility to EOL products. You may also have to check for new notifications by EU on WEEE regularly to see if there is any additional responsibility because of the new notification.

By the way, unlike consumer electronics products, Medical Devices have a long life and generally go for reuse /re-manufacture / repair many times before finally disposed.

With kind regards,

Ramakrishnan
As a manufacturer of disposable medical electronics product, is it just ok if the product has a cable tag on it or on the IFU / packing label with this symbol ... ?
 

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Dr. L. Ramakrishnan

Forum Moderator
Moderator
#4
Re: Medical Devices and the WEEE (Waste Electrical and Electronic Equipment) Directiv

Dear Somashekar,

The symbol has to be present on the EEE product (falling under the 10 categories identified by WEEE Directive) to enable EOL take back and recycling.

With kind regards,

Ramakrishnan
 

xcanals_tecno-med.es

Quite Involved in Discussions
#5
Re: Medical Devices and the WEEE (Waste Electrical and Electronic Equipment) Directiv

Usually the environmental issues are treated at country level, for example for the green dot the country importer is the responsible for the fees payement.
In the case of the WEEE depends on the agreement with the manufacturer but usually are payed and managed by the country distributor.
In Spain the importer/manufacturer must be registered in the Ministerio de Industria and be a member of a SIG (waste Integrated Management System for example ECOEMBES) or do individually the retirement of the old equipment
Also they pays taxes according the weight of the equipment sold each quarter

Regards

Xavier
 
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