Distributor information on Medical Device label

[Ahmed.]

I have a question about the necessity to mention the name and information related to the distributor on the medical device label. My question has 3 parts:

1. Does the EU MDR explicitly require distributors (like importers) to mention details on the medical device label? Is this mandatory? According to my understanding of the regulation, this is not required, provided that there are no changes or re-labelling that has occurred.

2. Do distributors in the EU, selling a device from within the EU in any case, prefer to write their information on the medical device label (provided that they are not distributors but only importers)

3. Are importers absolutely required to mention details on the medical device label? Is this mandatory?

 

[Nichole F]

1. No. Distributors are not required to place their information on the device unless Article 16 is applicable.
2. I'm confused. If the device was manufactured within the EU, an Importer isn't needed.
3. No. The importer information may be on any document that accompanies the device. So in theory it can go on the packing slip, invoice, etc. Keep in mind the intention of the requirement is that this information reaches the end user so if you are selling via distributors, putting the Importer information on the invoice or packing slip may not be effective. Also, it is the Importer's responsibility to ensure their information gets appropriately communicated, not the manufacturer/distributor. The distributor does have the responsibility to check that the requirement has been met though.