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[FONT="]Regulatory intricacies regarding tertiary packaging of class III medical devices, for distribution in non-EU Countires.
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[FONT="] Hoping very much to solve a theoretical problem...any help and experience is much appreciated!
[/FONT]
[FONT="]Scenario is as follows: [/FONT]
[FONT="]- [/FONT][FONT="]The manufacturer (EU based company) has been issued a new CE number due to a change in its Notified Body.[/FONT][FONT="] Some tertiary packaging (folding boxes) of the devices still carry the old CE number, as the stock had not yet been depleted.
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[FONT="]Distribution in non- EU non-GHTF countries:
[/FONT]
[FONT="]Given that, the following solution is only for labelling on the folding boxes and only until the stock is depleted [/FONT][FONT="]and the sicker should have a permanent nature (not easily removable). [/FONT]
[FONT="]--> Can the manufacturer place a sticker of the new CE number over the old one? [/FONT][FONT="]
[/FONT]
[FONT="]
[/FONT]
[FONT="]Any experiance? [/FONT][FONT="]Thank you!
[/FONT]
[FONT="]
[/FONT]
[/FONT]
[FONT="] Hoping very much to solve a theoretical problem...any help and experience is much appreciated!
[/FONT]
[FONT="]Scenario is as follows: [/FONT]
[FONT="]- [/FONT][FONT="]The manufacturer (EU based company) has been issued a new CE number due to a change in its Notified Body.[/FONT][FONT="] Some tertiary packaging (folding boxes) of the devices still carry the old CE number, as the stock had not yet been depleted.
[/FONT]
[FONT="]Distribution in non- EU non-GHTF countries:
[/FONT]
[FONT="]Given that, the following solution is only for labelling on the folding boxes and only until the stock is depleted [/FONT][FONT="]and the sicker should have a permanent nature (not easily removable). [/FONT]
[FONT="]--> Can the manufacturer place a sticker of the new CE number over the old one? [/FONT][FONT="]
[/FONT]
[FONT="]
[/FONT]
[FONT="]Any experiance? [/FONT][FONT="]Thank you!
[/FONT]
[FONT="]
[/FONT]