I think they are fundamentally misinterpreting the meaning of "an additional CE mark"; this refers to applying a CE mark to the procedure pack itself.
what do they define as a CE mark? It is merely a symbol. Are they saying it is a single product? or a single product group (i.e grouped within a technical file?)? Are they saying that you as a manufacturer only have a single CE mark for all your products? - What a load of rubbish
Taken from the directive: "Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive". A CE mark holds no intrinsic value, it is nothing but a symbol. Medical devices must undergo conformity assessment and as evidence of this they are CE marked, by way of derogation, devices that have already undergone conformity assessment can be bundled together but should not have an additional CE symbol added (as they have not undergone conformity assessment)
I'm glad I'm not in your position, I'm not sure I would be able to maintain an air of professionalism in front of whoever you are talking to.
I would recommend speaking to the competent authority and getting their, hopefully, more rational opinion.
The only scenario I can see where a notified body needs to be involved is if you wish to remove the manufacturer details from the OEM product and apply your own, this is outside the scope of article 12 and from my understanding of your posts not something that you want/intend to do
[edited with a helpful addition to your attachement]
what do they define as a CE mark? It is merely a symbol. Are they saying it is a single product? or a single product group (i.e grouped within a technical file?)? Are they saying that you as a manufacturer only have a single CE mark for all your products? - What a load of rubbish
Taken from the directive: "Whereas medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive". A CE mark holds no intrinsic value, it is nothing but a symbol. Medical devices must undergo conformity assessment and as evidence of this they are CE marked, by way of derogation, devices that have already undergone conformity assessment can be bundled together but should not have an additional CE symbol added (as they have not undergone conformity assessment)
I'm glad I'm not in your position, I'm not sure I would be able to maintain an air of professionalism in front of whoever you are talking to.
I would recommend speaking to the competent authority and getting their, hopefully, more rational opinion.
The only scenario I can see where a notified body needs to be involved is if you wish to remove the manufacturer details from the OEM product and apply your own, this is outside the scope of article 12 and from my understanding of your posts not something that you want/intend to do
[edited with a helpful addition to your attachement]
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