On-product labels for Medical Devices

[JoCam]

Hi All,

Can the information required to be present on a medical device on-product label be spread across more than one label, or should the manufacturer try to keep to just one, especially when there is enough room to do so.

JoCam

 

[yodon]

I'm not aware of anything that limits your labeling to 1. I know we've used multiple labels at times (one for the static info and one for the 'variable' info; e.g., mfg date). I think we've always put them in pretty close proximity of each other.

 

[Azhar Anwar]

The regulation itself does not specify how many labels can be palced on a device.
As long as it is legible, indelible , sufficient ..etc

 

[Billy Milly]

It is worth mentioning that information included in "labelling" is all information present on the packaging - you can also combine the box (pre)print for some information and label for the other, if sutable for your case.