tehuff

Involved In Discussions
#1
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!
 

Stijloor

Staff member
Super Moderator
#2
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.
 
#4
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.
 
#5
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).
 

tehuff

Involved In Discussions
#6
Excellent! "End Product Certification" were the keywords I needed to move forward - you guys on the Cove are the best!!:tg:
 

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