Applications required for main accessories (electrodes) of CE Medical Products

B

bennylee

#1
Dear All,

  • Our company have some products that help for Incontinence treatment. such product includes main device & electrode probe.
  • When used product, Device must need to be equipped with electrode probe, electrode probe is very important part of device (applied part of this products)
  • For such Incontinence products, we have passed CE application from our notified body.

Question (1)
If we want to sell electrode probe independently to EU market (Intended for use of probe is to use with Incontinence Device), may we know if we need to apply Medical CE for such electrode probe ?

Question (2)
If we only sell electrode probe as accessories to the same EU customer that ordered the Incontinence Product , may we know if we need to apply Medical CE for electrode probe independently ?

Best Regards,
Benny
 
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Stijloor

Staff member
Super Moderator
#2
A Quick Bump!

Can someone help?

If your questions were answered here, please consider helping others.

Thank you very much!
 

c.mitch

Quite Involved in Discussions
#3
Hi
Q1: you could sell it without CE mark, leaving the responsibility of affixing the CE mark to the buyer. This is called own brand labelling (OBL).
Q2: yes, accessories of medical devices must have the CE mark. Just have a look at article 1 of CE directive, accessories must comply to the same rules as medical devices. However, they are classified in their own right. Follow rule of annex IX for classification, like for medical devices.

Hope it helps.
 
B

bennylee

#4
Thanksfor your information!
For Q1, it is fine .
For Q2, I still have 1 question.

For our case, intended for use of probe is used for this CE product only, probe will not use for other products.
Hence, can we say "As "product Z" got CE, it also applies to any part of "product Z". If such part is used for "accessories of product Z" only, we don't need to apply CE indenpendently"
 

somashekar

Staff member
Super Moderator
#5
Thanksfor your information!
For Q1, it is fine .
For Q2, I still have 1 question.

For our case, intended for use of probe is used for this CE product only, probe will not use for other products.
Hence, can we say "As "product Z" got CE, it also applies to any part of "product Z". If such part is used for "accessories of product Z" only, we don't need to apply CE indenpendently"
Your product Z is assessed together with the electrode in the various testing and in the technical file. The electrode is a medical device in its own right and it can be packaged and put into the market independently. The simplest and the correct way is then to CE mark your electrode. Your justification as mentioned is not necessary, and will not be accepted as a regulatory justification.
This electrode product is your device and it will bear your name and address. Your customer may then freely distribute / use this device as replacement accessory for product Z only, however it is looked upon as a medical device in its capacity even without the product Z and CE mark then becomes a regulatory requirement.
Have you not considered the electrode as a separate device within your technical file ? Does it not appear on your CE certificate ... ?
If so, you have to quickly talk with your NB. If so, then your NB has not given you right directions and perhaps will cost you more now to CE mark them.
 
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