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Medical Devices and the WEEE (Waste Electrical and Electronic Equipment) Directive
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Medical Devices and the WEEE (Waste Electrical and Electronic Equipment) Directive
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weee (waste electrical and electronic equipment), medical devices
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  Post Number #1  
Old 31st May 2010, 08:57 AM
ISO 13485 - Medical

 
 
Total Posts: 60
Please Help! Medical Devices and the WEEE (Waste Electrical and Electronic Equipment) Directive

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?

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  Post Number #2  
Old 31st May 2010, 10:54 AM
Dr. L. Ramakrishnan

 
 
Total Posts: 496
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/...24:0038: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
Thank You to Dr. L. Ramakrishnan for your informative Post and/or Attachment!
  Post Number #3  
Old 31st May 2010, 12:15 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,362
Re: Medical Devices and the WEEE (Waste Electrical and Electronic Equipment) Directiv

Quote:
In Reply to Parent Post by Dr. L. Ramakrishnan View Post

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/...24:0038: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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Medical Devices and the WEEE (Waste Electrical and Electronic Equipment) Directive-weee_bin-jpg  
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  Post Number #4  
Old 31st May 2010, 10:05 PM
Dr. L. Ramakrishnan

 
 
Total Posts: 496
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
Thanks to Dr. L. Ramakrishnan for your informative Post and/or Attachment!
  Post Number #5  
Old 2nd July 2010, 08:56 PM
xcanals_tecno-med.es's Avatar
xcanals_tecno-med.es

 
 
Total Posts: 90
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
Thanks to xcanals_tecno-med.es for your informative Post and/or Attachment!
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