Hi All,
Always appreciate and respect the great advice that comes through this forum:
The scope of my question is CE Mark of a Class IIa medical device system under the MDD (and then eventually MDR):
We have Class I devices which will be CE Marked through self-certification.
These devices can be used with other CE marked products (not owned by us).
One of which is not CE Marked as a medical device (conformity to machinery and low voltage directives).
In terms of what we consider this vendor, what is our safest bet to ensure a successful CE Mark application under the MDD?
I was thinking re-seller (our brand label goes on their product) so that we are not responsible for their documentation into our technical file; we'd simply be pulling ~6 CE Marked products into a medical device system. (one of the products is IIa, which is why we chose this system classification)
Private Label Manufacturers (PLM) and company's from which you re-sell are not subject to a potential audit from your NB, correct?------------------------------
April Komplin
United States
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