‡ In these countries please contact our distributor

Direct Part Marking

Another mandate for UDI compliance, Direct Part Marking, requires the UDI be permanently added to reused and reprocessed devices at the point of manufacture.

Adobe Acrobat PDF icon Read the draft guidance document on Direct Marking issued by the FDA for Industry and FDA staff (PDF)

More specifically, a medical device must bear a permanent mark with the Unique Device Identifier if all of the following factors apply:

check mark The UDI is required on the device label

check mark The device is intended to be used more than once

check mark The device is reprocessed before each use.

This will enable traceability of these devices after they are separated from their labeling or packaging.

Class II and Class I instruments make up the majority of our products that need to be marked.

The FDA deadline for Class III instruments is September 2016. Class II products must be compliant by 2018, with Class I devices following in 2020.

We have chosen to implement 2D Barcoding with Human Readable text wherever possible.

human readable bar code

Contact us

If you have any questions regarding our implementation of the Unique Device Identifier, please contact the Smith & Nephew UDI program director