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Bluetooth Class II Medical Device - Which Directives?

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Some Related Topic Tags
bluetooth device, ce mark and ce marking, class ii medical device, european union, mdd (medical device directive), r&tte (radio and telecommunications terminal equipment), medical devices
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  Post Number #1  
Old 30th November 2010, 08:03 PM
tehuff

 
 
Total Posts: 57
Question Bluetooth Class II Medical Device - Which Directives?

Hi all,
I am working with a client who has a class II medical device that transmits data via Bluetooth wireless to custom software. They want to get CE marked. Other than the MDD, I believe the RTTE directive also applies. Is this correct? Are the other directives that I may not be aware of? Software guidances for EU?

Thanks!

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  Post Number #2  
Old 1st December 2010, 07:57 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: Bluetooth Class II Medical Device - Which Directives?

Quote:
In Reply to Parent Post by tehuff View Post

Hi all,
I am working with a client who has a class II medical device that transmits data via Bluetooth wireless to custom software. They want to get CE marked. Other than the MDD, I believe the RTTE directive also applies. Is this correct? Are the other directives that I may not be aware of? Software guidances for EU?

Thanks!
Can someone help?

Thank you!!

Stijloor.
  Post Number #3  
Old 18th March 2011, 05:16 PM
tehuff

 
 
Total Posts: 57
Re: Bluetooth Class II Medical Device - Which Directives?

Anyone got any ideas on this? I need some help - thanks!
  Post Number #4  
Old 22nd March 2011, 06:48 AM
Pads38

 
 
Total Posts: 771
Re: Bluetooth Class II Medical Device - Which Directives?

My understanding is that if you are implementing Bluetooth with a bought-in module it will be certificated as a 'Bluetooth End Product' which should be all the qualification that you require.
Thanks to Pads38 for your informative Post and/or Attachment!
  Post Number #5  
Old 23rd March 2011, 01:01 AM
Peter Selvey

 
 
Total Posts: 907
Re: Bluetooth Class II Medical Device - Which Directives?

To answer the original question: Only MDD and RTTE are expected to be applicable. There should be no other applicable directives associated with CE marking.

Software would be handled under the MDD. There are essential requirements and standards associated with software (e.g. EN 60601-1; EN 62304).
  Post Number #6  
Old 25th March 2011, 01:08 PM
tehuff

 
 
Total Posts: 57
BIG Smile Re: Bluetooth Class II Medical Device - Which Directives?

Excellent! "End Product Certification" were the keywords I needed to move forward - you guys on the Cove are the best!!
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