MDD Article 12 Labeling Requirements for CE Marked Medical Device - Help

fialor

Involved In Discussions
#1
My company makes a device which is CE marked as a whole.
However one of the components in the device is itself CE marked(a device in itself), and the CE mark is visible on the component at point of use.
NB advises that this requires an article 12 labelling.

I disagree that this is required as the component is incorporated into our device. I amybe wrong - please enlighten me if I am.

I do accept though that labelling of some sort is required here so the user is aware of whom to contact as the sole manufacturer of the device.

My question is what labelling and wording? I am new to procedure packs and not sure this is straight forward. Can you help?
Thanks
 
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Ronen E

Problem Solver
Moderator
#2
My company makes a device which is CE marked as a whole.
However one of the components in the device is itself CE marked(a device in itself), and the CE mark is visible on the component at point of use.
NB advises that this requires an article 12 labelling.

I disagree that this is required as the component is incorporated into our device. I amybe wrong - please enlighten me if I am.

I do accept though that labelling of some sort is required here so the user is aware of whom to contact as the sole manufacturer of the device.

My question is what labelling and wording? I am new to procedure packs and not sure this is straight forward. Can you help?
Thanks
Is your device conceived as a procedure pack?

Article 12 is voluntary. You are at liberty to handle your device as a "normal" medical device, and there are no special requirements that I'm aware of for normal devices that contain components that are already CE marked in their own right (even if they're also medical devices in their own right). Article 12 is supposed to save you work and be an easier / simpler route to market (where it is relevant). It's not meant as extra-burden if you already follow Article 11.

If all that can be seen on the integrated device (component) is the CE marking there shouldn't be any confusion. I think a clarification would be necessary only if its manufacturer and their contact details are also visible in your final configuration.
 

fialor

Involved In Discussions
#3
It is article 11 compliant. However the CE mark and Number of the device (in its own right ) can be seen when the components are assembled together. The packaging at present clearly states that the device is manufactured by us, and to contact us if there are any issues.
The NB seems to think article 12 is also applicable, and I do not know enough to be able to challenge that position.
 

Ronen E

Problem Solver
Moderator
#4
It is article 11 compliant. However the CE mark and Number of the device (in its own right ) can be seen when the components are assembled together. The packaging at present clearly states that the device is manufactured by us, and to contact us if there are any issues.
The NB seems to think article 12 is also applicable, and I do not know enough to be able to challenge that position.
Not sure what you mean by "CE mark and Number of the device". If you ferreted to the number right next to, or right below, the CE mark, it's the number of the NB that certified (EC certificate) the device. In my opinion it doesn't contribute to confusion regarding the manufacturer of your device.

Article 12 is provided as an exemption from Article 11, if the manufacturer is eligible to use it and explicitly chooses to do so. Its s. 2 states that it applies to

Any natural or legal person who puts devices (...) in order to place them on the market as a system or procedure pack (...)
Is that your stated intention?

Would you like me to challenge your NB on your behalf...? :lol:
 

fialor

Involved In Discussions
#5
Thanks Ronen.
I had meant CE mark with the NB number (not the device number).

I think my NB might run if I set you on them, and never come back! :D
Thanks though.

Yes - I have previously advised your emphasis in your last response, but there is still not a budge. I think at this stage I just need to have a meeting and take it from there.
Thanks for the help.
Fialor
 
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