Hello everyone,
I was hoping you could provide some insight based on your expertise with the following question:
What regulatory pathway should be followed in the EU to obtain approval for commercializing products that consist of an approved integral combination product and a CE-marked product, each individually packaged in their primary packaging? The additional CE-marked product is not a component of the combination product but instead serves as an accessory to the medical procedure in which both products are used.
They are not physically attached together. Can I virtually bundle them as they own their identification label information?
Is there another path to follow other than co-packaging or cross-labeling?
Additional Inputs:
The co-packaged products are:
1. An approved medicinal product (integral drug-device combination) - Medicinal Product Directive 2001/83/EC (MPD) + NB Opinion (article 117).
2. An approved CE-Marked medical device – Medical Device Regulation 2017/745 (MDR), which serves as an accessory for the medical procedure and does not combine with the medicinal product.
Both with their primary packaging, approved label, and intended use are co-packaged as a whole in a further package and labeling for medical procedure convenience.
Each component is regulated and approved under its relevant regulation.
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Mauro
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