pmpnews.com • Pharmaceutical & Medical Packaging News Fall 2016 28
Printing & Coding
8 potential UDI code
readability issues and the
critical role of vision
Can vision technology overcome printing and coding issues?
By Kasey Tipping, Technical Marketing Specialist–ID Products,
Cognex Corp.
S
eptember 2016 brings sever-
al key deadlines for Unique
Device Identification (UDI),
a system of medical device
identification rules issued by
FDA in 2013. UDI requirements state
that the device labeler, in most cases
the manufacturer, must include on
medical devices a device identifier (DI)
that identifies the labeler and the spe-
cific version or mod-
el of device and a
production identifier
(PI) that includes
o n e o r m o r e o f
the following: lot
or batch number,
serial number of a
specific device, expiration date of the
device, and the date the device was
manufactured.
As medical device manufacturers
work toward compliance, they are
encountering serious challenges, par-
ticularly in reading UDI codes. This
article will identify 8 types of readabili-
ty issues manufacturers may encounter
and explain how sophisticated vision
technology could help address them.
THE RULES
While Class III medical devices have
been required to carry UDI labeling
since September 2014, by September
24, 2016, these Class III devices must
carry UDI as a permanent mark on
the device itself if that device is intend-
ed to be used more than once and is
intended to be reprocessed before use.
In addition, all Class II devices must
now bear UDI on their labels and
packages, and the dates on these labels
must meet formatting rules (implant-
able, life-saving, and life-sustaining
Class I and II devices have had to
carry UDI labeling since September
2015).
By September 2018, all Class I
devices must carry UDI labeling, and
Class II devices that require DPM
must carry the UDI on the device.
Finally, Class I devices that require
DPM must carry a permanent UDI
on the device by September 2020. (For
details, visit www.fda.gov/MedicalDe-
vices/DeviceR egulationandGuid-
ance/UniqueDeviceIdentification/
C o m p l i a n c e d a t e s f o r U D I R e q u i r e -
ments/default.htm.)
Kasey Tipping
To overcome warped 2-D DataMatrix codes or codes with missing perimeter features, Cognex offers
2DMax with PowerGrid algorithm. PowerGrid reads codes without quiet zones or clocking or fnder patterns.
