Minimum label content requirements for each level of packaging (inner, outer, etc)

C

Chris_H

#1
Could someone tell me where I can find a report that list the minimum label content requirements for each level of packaging (i.e., inner label, outer label, shipper and/or pallet)? We manufacture Type I and type II medical devices.

Also, is there a symbol for "Units"? Or, any suggestions?

Please help!


thanks!
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: Minimum label content requirements for each level of packaging (inner, outer, etc

I have moved this post to this forum since it asking about labels for the Medical Device Field.
 

Ajit Basrur

Staff member
Admin
#3
Re: Minimum label content requirements for each level of packaging (inner, outer, etc

Could someone tell me where I can find a report that list the minimum label content requirements for each level of packaging (i.e., inner label, outer label, shipper and/or pallet)? We manufacture Type I and type II medical devices.

Also, is there a symbol for "Units"? Or, any suggestions?

Please help!

thanks!
Hi Chris,

Welcome to the Cove :bigwave:

Take a look at Introduction to Medical Device Labelling - its very informative and could answer most of your questions. :)
 
M

MIREGMGR

#4
Re: Minimum label content requirements for each level of packaging (inner, outer, etc

You're a US participant and you make "Type I and Type II" medical devices, so there's ambiguity as to what regulatory system you're asking about...

FDA, or ISO 13485?
 
C

Chris_H

#5
Re: Minimum label content requirements for each level of packaging (inner, outer, etc

Thank you for your response.

Actually, both FDA and ISO. I will start on the link you've provided.
 
H

Hannah_N

#6
Re: Minimum label content requirements for each level of packaging (inner, outer, etc

Hi,

In my previous job at a European IVD and medical device manufacturer we used the following standards:

- EN 375:2001 -Information supplied by the manufacturer with in vitro diagnostic reagents for professional use

- EN 376:2002 - Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing

And there is a new one for medical devices:
- EN 1041:2008 - Information supplied by the manufacturer of medical devices

Not sure how helpful/important standards by the European Committee for Standardization are to you though. :)
 
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