Regulatory Open Forum

Hi all,

Good morning.

We have a private label under our company where we are the manufacturer of the private label.

In this case, should we also be handling the UDI?

Hi Lulu,

from the point of view of regulatory requirements, this depends to a large degree on the jurisdiction.

In the EU the UDI must be assigned by the manufacurer (meaning legal manufacturer in the sense of the MDR) or for systems/procedure packs the legal entity that assembles them.

In the US it is as far as I know in the responsibility of the "labeler" which usually is the manufacturer but offers more flexibility (see https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics).

For other jurisdictions requiring a UDI this might be different.

Best regards

Christoph

Hi all,

Good morning.

We have a private label under our company where we are the manufacturer of the private label.

In this case, should we also be handling the UDI?

Thank you Christoph for your reply.

It helps a lot. Really appreciate it.

Lulu

Hi Lulu,

from the point of view of regulatory requirements, this depends to a large degree on the jurisdiction.

In the EU the UDI must be assigned by the manufacurer (meaning legal manufacturer in the sense of the MDR) or for systems/procedure packs the legal entity that assembles them.

In the US it is as far as I know in the responsibility of the "labeler" which usually is the manufacturer but offers more flexibility (see https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics).

For other jurisdictions requiring a UDI this might be different.

Best regards

Christoph

Hi all,

Good morning.

We have a private label under our company where we are the manufacturer of the private label.

In this case, should we also be handling the UDI?

Hi Lulu,

Christoph is correct depends on the jurisdiction.  In your situation as a private labeller, for the US FDA you could be the "Labeller" and manage the UDI.  Though often times in a private label circumstance, aspects of the UDI are shared between the companies.  Definitely would want to make sure this is defined in an agreement/contract as to who is responsible for what.

Thank you Christoph for your reply.

It helps a lot. Really appreciate it.

Lulu

Hi Lulu,

from the point of view of regulatory requirements, this depends to a large degree on the jurisdiction.

In the EU the UDI must be assigned by the manufacurer (meaning legal manufacturer in the sense of the MDR) or for systems/procedure packs the legal entity that assembles them.

In the US it is as far as I know in the responsibility of the "labeler" which usually is the manufacturer but offers more flexibility (see https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics).

For other jurisdictions requiring a UDI this might be different.

Best regards

Christoph

Hi all,

Good morning.

We have a private label under our company where we are the manufacturer of the private label.

In this case, should we also be handling the UDI?