UDI Labeling for Medical Device Samples

[kellascat]

Are we required to UDI label medical device samples packs sent to customers for device evaluation?

For example,
P/N 970 Surgical Skin Markers 100/Box is UDI Labeled and listed on the GUDID

Customers want to evaluate the markers before buying a large quantity, so we send a 5 Marker Sample Pack for evaluation.

Are we required to UDI label the sample pack and list on the GUDID database?

 

[ScottK]

Are we required to UDI label medical device samples packs sent to customers for device evaluation?

For example,
P/N 970 Surgical Skin Markers 100/Box is UDI Labeled and listed on the GUDID

Customers want to evaluate the markers before buying a large quantity, so we send a 5 Marker Sample Pack for evaluation.

Are we required to UDI label the sample pack and list on the GUDID database?

How are they going to evaluate them?
If they are going to evaluate them in their stated use and use them on patients, then I would say yes - these samples are no different than the product you are selling.

If they are not going to use them on patients, only for testing and handling, I would say "no but..." The 'but' being that they should be marked as "evaluation only, not for use on patients" or similar.

 

[debbier]

I recently had this same question and contacted the UDI Help Desk, this was their response:

"Samples are considered to be in commercial distribution and therefor UDI requirements apply."