Labeling of Devices - MDD to Label both Pouches of a Sterile Device

M

MIREGMGR

#11
As far as I know, there is no clear rule or guidance from the central EU authorities on EU acceptability of USFDA-specific, non-harmonized label content requirements in excess of EU requirements. My understanding, specific to our Class I-s and IIa products, is that one's NB is authoritative.

Most of our 2000+ products (roughly 1/4 under our brand, the others private labeled for a variety of multinational OEMs and regional distributors) are globally labeled. Many of those products are labeled as USFDA RX Only. Generally those labels are symbolized to the extent possible, with English-only subtext for each such symbol to satisfy USFDA refusal to accept symbol-only labels. Many of those labels are multi-language with regard to non-symbol-associated, not-otherwise-regulatorily-excluded text. Our well-known NB accepts this approach.
 
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