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Labelling to comply with both FDA and MDR

#1
We're a small (and young) company that manufactures a Class I device. While we're based in the US, the device is contract manufactured in India. The device also has a CE Mark, but that registration falls under our subsidiary company based in the EU. We want to sell the devices in the US, EU, and to some other countries as well.

What would a label need to include in order to fulfil both FDA and MDR requirements? More specifically, what address should appear next to the manufacturer symbol (our US office? EU office? both?). Does the contract manufacturer have to be on the label? If so, is their full address also required?

Or do we need a different label for devices being sold to the US and for devices being sold to the EU?

Any help would be most appreciated. Thanks in advance!
 
Elsmar Forum Sponsor
#3
Between UDI basics listed above and ISO 15233, should have a clear idea of what's on it. Keep in mind, that EU has translation requirements too, this is where accompanying labeling (manual/inserts) are very important. Manufacturer and Where it is manufactured are different things, basically: Who is responsible if this product harms someone? Check the definitions section on MDR/21CFR, also see Labeler in UDI basics
 
#4
Thank you both for sharing this information. I'll review the links that have been shared and ISO 15233.

Just one further question - is it possible in principle to have the same label comply with both the FDA and MDR as long as all relevant information is included?

Thanks again!
 
#5
Probably yes, I think this one varies based on your product/marketing requirements. I've dealt mostly with Class II devices that had a universal label. Things could be different based on your class/branding/label size etc. I would suggest draft 2 labels to start, then see if you can combine without causing confusion or inaccuracy. This could also be something for you to take credit for in your device risk matrix.
 

Ajit Basrur

Staff member
Admin
#6
Also refer the ISO - ISO 20417:2021 - Medical devices — Information to be supplied by the manufacturer

This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.
 
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