Managing Director, Acorn Regulatory
Implementation of UDI requirements poses a particular challenge to medical
device OEMs. Many mistakes being made by OEMs and/or their supply/service
partners are a lack of clear, structured processes and policies.
OEMs must ensure that responsibilities for UDI activities are clearly outlined in quality
agreements/contracts with their supply partners. A process for exchanging UDI codes between
the OEM and its partners must be defined and time-related goals for UDI implementation
must be agreed upon and coordinated. Manufacturers should define their approach and plans
in documented, logical, and reasonable policies and procedures, which should be communicated with supply partners, ensuring that a solid infrastructure is in place. As the implementation
rolls out and more regulatory guidance is given, companies must be prepared to learn, adjust,
and evolve. Failure to invest time in extensive planning and communication is one of the big
mistakes we see. MDT
Vice President of Healthcare, GS1 U.S.
Since UDI was passed, end users responsible for implementing the solution in their
companies are concerned with the right way to approach compliance. Companies
may not be clear on who is responsible for UDI — the labeler or contract manufacturer. The labeler is responsible for UDI to ensure traceability directly from the source.
Many question which date convention to use — ISO or GS1? UDI requires the ISO standard
“yyyy-mm-dd” format on the label — confusing for those familiar with the GS1 standard six-digit
date barcode format. A manufacturer may have a sellable unit with a package of two products,
unaware those inside the package must be assigned a global trade item number, even if unmarked.
Organizations should designate a single point of contact for the GS1 standard in the U.S.
to simplify resolution of these issues for the FDA. This will ensure a consistent application of
UDI and the highest quality data going into the GUDID. MDT
Q:Regarding the implementation of UDI (unique device identification) across the medical device industry, what
mistakes are being made?
Some OEMs do not fully
understand the requirements,
including the need to design
new systems that meet com-
pliance requirements while
maximizing the use of existing
hardware, software, and personnel. While
many have been through this process (first
compliance deadline was September 2014),
others have yet to address the regulation, as
new deadlines for different classes of devices
quickly approach. To adequately prepare,
1. What hardware/software is currently used
to manage inventory and distribution?
2. What volume of devices does the
3. Does the device production volume
allow manual key-in of the information
to the Global Unique Device Identification Database (GUDID), or will a
software solution capable of automated
transmission be needed?
4. Is there a staff member who understands
the relationship between the manufacturer and the FDA, who is also qualified to
prepare data for the GUDID?
Some manufacturers are uncertain or
have misperceptions about implementation
time and cost, leading to delays. Develop a
detailed budget and project timeframe for implementation, consider all necessary variables,
and allow flexibility for unforeseen setbacks.
Also, consider meeting with a supplier
or systems integrator to expedite the scope
and implementation of a UDI-compliant
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