Regulatory intricacies - tertiary packaging of class III MD

#1
[FONT=&quot]Regulatory intricacies regarding tertiary packaging of class III medical devices, for distribution in non-EU Countires.
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[FONT=&quot] Hoping very much to solve a theoretical problem...any help and experience is much appreciated!
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[FONT=&quot]Scenario is as follows: [/FONT]
[FONT=&quot]- [/FONT][FONT=&quot]The manufacturer (EU based company) has been issued a new CE number due to a change in its Notified Body.[/FONT][FONT=&quot] 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=&quot]Distribution in non- EU non-GHTF countries:
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[FONT=&quot]Given that, the following solution is only for labelling on the folding boxes and only until the stock is depleted [/FONT][FONT=&quot]and the sicker should have a permanent nature (not easily removable). [/FONT]

[FONT=&quot]--> Can the manufacturer place a sticker of the new CE number over the old one? [/FONT][FONT=&quot]
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[FONT=&quot]
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[FONT=&quot]Any experiance? [/FONT][FONT=&quot]Thank you!
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello and welcome to the Cove!

The answer depends on the country. Some non-EU countries have legal provisions that rely on CE marking and maybe on associated labelling / marking.
 
#3
Thank you for such a fast response!!

Yes, it is true that a growing number of non-EU countries have legal provisions that rely on CE marking and associated labelling / marking.

The dilemma is: which countries are free enough to AND also practice their own regulations allowing marking with a semi-permanent sticker
and
The CE Marking does communicate current compliance and is correct...just the labelling of the outer box is (as an interim solution) supposed to be a sticker instead of print....

Any suggestions of literature/ lists?


Thank you again!
 
#5
It is for un upcoming pannel discussion and not a happening live. Basically a sort of homework question, wherby solutions and answers are expected for upcoming discussion...
 

pkost

Trusted Information Resource
#6
You should look less at the regulation and more at the contract between manufacturer and NB. I suspect that there will be a clause there that prohibits use of their number
 

Sarah Stec

Involved In Discussions
#7
The dilemma is: which countries are free enough to AND also practice their own regulations allowing marking with a semi-permanent sticker
and
The CE Marking does communicate current compliance and is correct...just the labelling of the outer box is (as an interim solution) supposed to be a sticker instead of print....

Any suggestions of literature/ lists?
Making a list of countries that would "allow" this may not be the best way to respond to this question. This list that you make today changes from day to day, situation to situation, and saying things like "Country X has their own regulations, but they don't monitor their labeling regulations very well so you can go ahead and sticker over the old NB number" can lead someone down a wrong path, in my opinion. Especially when the answer is probably something more like that "it depends on what the new NB and old NB allow the manufacturer to do with their number, in combination with whether the country's regulator will allow such relabeling to take place given where the product is in the import/distribution chain, and whether or not it matters in that specific country given their regulatory regime." :2cents:

Pkost has a point that the contract with the NB would dictate the conditions under which the manufacturer can use their number. Each NB will handle this in their own way. IME, the new NB needs to know how much product is going out with their predecessor's number on it for their own risk management.
 
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