Physical Address on Product Labels (EU MDR perspective)

Ajit Basrur

Leader
Admin
I have a question regarding the mention of the physical address on the product label from an EU MDR perspective.

According to 21 CFR Part 801.1(d),
(d) The statement of the place of business shall include the street address, city, State, and Zip Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of non consumer packages, the ZIP Code shall appear on either the label or the labeling (including the invoice).

My question is from an EU perspective, how is the "registered place of business" interpreted with respect to physical address on the label? Is it acceptable to delete the street address as in 21 CFR 801.1(d)?
 

jham65

Registered
This is information provided from my Regulatory Consultant:

Yes, it is required to include the street address of both the legal manufacturer and the authorized representative, and should be the physical address, not a PO Box. Please see attached some guidance on what needs to be on the label and the instructions for use. This was developed per the requirements of section 13.3 of the Essential Requirements in the Medical Devices Directive.

If you provide an instructions for use, then the full address should be noted. The same would apply for the outer packaging labeling. I’ve pasted below some information from the attached Label guide for reference:

The function of the label is to identify who is responsible for the device and how he can be contacted. It also provides additional information for proper and safe use if this is appropriate.

Each single device should have a label and if devices are packed with more than one in larger box, that outer package should also have a label. However, if there are technical reasons a label cannot be attached to the device, the outer package is acceptable.
 
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