Article 16 MDR - Medicine packaged together with Medical Device

#1
Dear All,
I need you help!!
One of my client is a MAH of a medicine packaged together with MD. The latter are supplied by manufacturers and placed – by the global- in the same package containing the drug. According to the new MDR the Affiliate has obligations as a distributor (Article 14). However, as the inclusion of the MD inside the package is a repackaging/relabelling activity, the provisions of Article 16 apply.

First question: Do you agree with this scenario?

Second question: The translation activity carried out by each Affiliate must be audited by the notified body? Shall the notified body audit the global or each affiliate?

According to article 16, point 4 of the MDR, 28 g before the product is placed on the market, the national competent authority must be informed. Do you have more information about this process?

Thank you in advance for any suggestion and support!
C.
 
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