Distributed Product - Labeling Requirements

A

AOIRA

#1
My company (manufacturer and distributor of ophthalmic devices) wants to distribute a medical device (vitrectomy cutter) that we purchase from the true manufacturer. The device is CE marked, and the package label and IFU appear to meet labeling requirements in Article 13 of MDD 93/42/EEC. I believe that Article 12 may apply in this situation, but that is for another discussion. My question is: can't I simply place the device, leaving the manufacturer's packaging and labeling intact, inside a clear poly bag and place my company's package label on the poly bag identifying us as the distributor (along with our part number and description of the device)? I have spent way too many hours reading the MDD, ISO 13485, 21CFR820, and numerous guidance documents and internet resources and have yet to find something in plain English advising me how to label medical device secondary packaging for distribution, regardless of destination. Thank you in advance.

Happy Holidays,
David
 
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L

Laura Halper

#2
Hi David,
What you describe should be acceptable for both the FDA and the EU. The FDA labeling requirements are found in 21CFR 801.1.

Since you are not re-packaging anything (just placing in an clear overbag), not changing any of the manufacturer's labeling, not adding new instructions for use, and clearly identifying yourself as the distributor, you also meet EU requirements. Note that the MDD uses the term "distributor" one time (Article 20(2)(b) regarding Confidentiality), so they do recognize the distributor function. But all MDD requirements fall on the manufacturer. Since you are not performing any of the functions of a manufacturer, you are not responsible for meeting those requirements.

Be sure the CE marking, manufacturer and/or authorized rep name/address are visible in the overbag.
 

Michael Malis

Quite Involved in Discussions
#4
My company (manufacturer and distributor of ophthalmic devices) wants to distribute a medical device (vitrectomy cutter) that we purchase from the true manufacturer. The device is CE marked, and the package label and IFU appear to meet labeling requirements in Article 13 of MDD 93/42/EEC. I believe that Article 12 may apply in this situation, but that is for another discussion. My question is: can't I simply place the device, leaving the manufacturer's packaging and labeling intact, inside a clear poly bag and place my company's package label on the poly bag identifying us as the distributor (along with our part number and description of the device)? I have spent way too many hours reading the MDD, ISO 13485, 21CFR820, and numerous guidance documents and internet resources and have yet to find something in plain English advising me how to label medical device secondary packaging for distribution, regardless of destination. Thank you in advance.

Happy Holidays,
David
Who is taking Legal responsibility for this product?

Is it your company? The Q is not about distribution, the Q is about Legal responsibility for the product...

When you put your name on the kit - you are now legally responsible for this device! Is this what you want to do?

Who is collecting complaints for this product?

Based on your answers, I will be able to provide a better direction...
 
A

AOIRA

#5
The true manufacturer remains legally responsible for the product, and collects complaints on the device. We are not kitting, but rather selling the device as an accessory to ours.
 
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