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
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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