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MDD 93/42/EEC and Leather - CE-marking our (class I) product

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leather, mdd (medical device directive), mdd 93/42/eec
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  Post Number #1  
Old 18th March 2009, 10:30 AM
johan.stenstrom

 
 
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Please Help! MDD 93/42/EEC and Leather - CE-marking our (class I) product

Hi,

I'm new on the forum so please forgive me if this is the wrong subforum.

My company is heading for CE-marking our (class I) product. One question that has come up is about point 8.2 in the essential requirements of the MDD. Is ordinary leather used for clothing etc. considered as animal tissues that have to be subjected to veterinary control?

Best Regards, Johan

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  Post Number #2  
Old 18th March 2009, 11:03 AM
MIREGMGR

 
 
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Re: MDD 93/42/EEG and leather

Do you have adequate evidence in your technical file that your intended use will be riskless in regard to "veterinary controls and surveillance adapted to the intended use of the tissues"?

If there is evidence of no risk, then I'd guess it could reasonably be determined that the required extent of "veterinary controls and surveillance" would be none.
  Post Number #3  
Old 20th March 2009, 02:26 AM
Roland Cooke

 
 
Total Posts: 614
Re: MDD 93/42/EEC and Leather - CE-marking our (class I) product

Those devices are given a pass, see page 40 of MEDDEV 2.4/1
Thanks to Roland Cooke for your informative Post and/or Attachment!
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