B
brandomenon
My company is looking to add to our product line by entering an agreement with a company to re-label their existing CE marked IVD with our branding. Both devices would then be available in the marketplace. We currently have a couple of self-declared CE marked IVD products (Class II).
How do we make sure all our regulatory bases are covered (i.e. what's the path of least resistance to CE marking the device with our labels on it)? The directive is clear that we are still the 'manufacturer' but does not provide much guidance on technical files or dealing with NB's.
Thanks!
How do we make sure all our regulatory bases are covered (i.e. what's the path of least resistance to CE marking the device with our labels on it)? The directive is clear that we are still the 'manufacturer' but does not provide much guidance on technical files or dealing with NB's.
Thanks!