Unique Device Identification (UDI):
Insights and Benefits from a Single UDI System in the International Arena

White Paper
January 2018

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EXECUTIVE SUMMARY
The implementation of a globally
harmonized unique device identification(UDI) system will positively impact many
aspects of the medical device and healthcare
ecosystem by increasing patient safety andoptimizing patient care. There are, however,considerations that must be examined andaddressed prior to the development oflocalized UDI requirements in a given
market.
These considerations include
labeling
requirements,
implementation
timelines, the treatment of products alreadyin commerce, and the assembly andmaintenance of a UDI database.
The United States Food and Drug
Administration (FDA) was the firstgovernment agency to issue and implement
UDI requirements. Manufacturers and the
public provided input throughout the UDI
rulemaking process and FDA sought input
from a broad set of stakeholders, including
the public, manufacturers, and othergovernment health agencies. FDA based its
rule on a number of international standards
and external consultations, consistent with
the International Medical Device Regulators
Forum (IMDRF).1 As a result of significant
thought and consideration, the FDA’s final
UDI rule achieves a balance of the regulator’s
needs and industry’s capabilities withoutcompromising patient and user safety. This

has led to a successful set of rules andpolicies.
A globally harmonized approach to UDI is
critical to realizing the benefits of such asystem, is a prerequisite for medical device
traceability in a globalized economy, and lays
the groundwork for the worldwide exchangeof medical device data.
In contrast, the creation of multiple UDI
regimes will stifle innovation in the medical
device industry, create product shortages, andcause confusion in the supply chain. For
example, different criteria regarding events
that trigger a new UDI for an existing productcould lead to unintended outcomes andincompatible data, including significant
changes to product labels, database entries, oradditional product registrations, which would
ultimately slow down time to market for
product changes and impact patient access.
In addition, variations among regions orcountries would add significant effort andcosts for device manufacturers, down-stream
customers, health systems, and patients
without any added benefit to patient safety.
Creating a globally harmonized UDI systemis achievable when countries adopt similar
UDI requirements. In this regard, a country
seeking to implement new UDI rules should
rely on the IMDRF UDI Guidance,2 along

2
1

See IMDRF, UDI Guidance, Final Document (Dec.
9, 2013), available at
http://www.imdrf.org/docs/imdrf/final/technical/imdr
f-tech-131209-udi-guidance-140901.pdf.

See IMDRF, UDI Guidance, Final Document, p. 3(“The UDI System is intended to provide a single,
globally harmonized system for positive
identification of medical devices. Healthcare
professionals will no longer have to access multiple,2

with reference to FDA’s final UDI rule as amodel for constructing rules of their own.
Below, we identify: (1) The important
aspects of the FDA’s final UDI rule thatshould be adopted globally; and (2)information learned while implementing therule. This information is intended to assist
the formulation of new UDI rules in aharmonized manner, which in turn will makecompliance more achievable—with more
efficient use of resources—for regulators andthe medical device and healthcare ecosystem,
ultimately enhancing patient safety.
As discussed more fully in this document, ourrecommendations are as follows:
1. UDI rules should be adopted in a
globally harmonized manner.
2. UDI rules should offer a phased inapproach with implementation basedon product risk classification. The
implementation period should begin
no less than two years from issuanceof the regulation and when the UDI
database is available.
3. UDI rules and policies should rely oninternational standards and globallyaccredited UDI issuing agencies, inaddition to the IMDRF UDI
Guidance, and consider the evolutionof UDI technology.
4. Manufacturers should be permitted tosubmit information to databases using

standards-based submission options
to account for their variation in sizeand capabilities, such as the use of
web interfaces or HL7 formats.
Globally standardized core data
elements should become the common
denominator for any national
implementation.
5. Regulators should provide assistancewhen implementing a new UDI
system, such as setting up a help desk,
providing training opportunities, andissuing guidance documents.
6. UDI rules should provide theregulator with an efficient andexpedient mechanism to grant
exceptions, exemptions, alternatives
and extensions that may exist for
specific product areas or for specificmanufacturers.
7. UDI rules should exempt all devices
manufactured or labeled prior to the
UDI rule effective date, including
those that are held on a consignment
basis.
8. Regulators should understand theimplementation variations that occur
between manufacturers with respect
to use of device identifiers andmaintain flexibility to account for amanufacturer’s specific needs bystaying within the establishedframework of the globally accredited
UDI issuing agencies.

inconsistent, and incomplete sources in an attempt toidentify a medical device and, its key attributes.”),3

9. Regulators should drive global
convergence for the use of new
product identifiers.

10. Implementation timelines related to
UDI database changes must accountfor industry’s needs to update internal
systems and processes.

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IMPLEMENTATION ASPECTS NOT COVERED IN THE IMDRF UDI GUIDANCE
UDI systems enable the linking of clinical records and information regarding device use, whichenable more effective device safety surveillance and evaluation studies. Such a link can lead to amore complete safety and effectiveness profile for devices, enabling appropriate and timely
remedies when potential safety concerns are identified. A globally harmonized UDI system willoffer a number of additional benefits, including:a) More efficiency, accuracy and automation of capturing product information in the global
supply chain;b) Increased visibility of device supply and movement through the healthcare supply chain
to the patient, which leads to a reduction of fraudulent and counterfeited devices;c) Reduction in the risk of device shortages;d) Better visibility for adverse events;e) More information for the healthcare industry and public through supporting UDI
databases, such as the FDA’s Global Unique Device Identification Database (GUDID)
public database;f) Increased global visibility to recalled devices;g) More effective mechanisms for healthcare providers to auto-capture device informationconsistently and accurately in systems and electronic medical records; andh) Reduction in medical errors.
In the context of this White Paper, UDI refers to “a series of numeric or alphanumeric charactersthat are created through a globally accepted device identification and coding standard. It allows
the unambiguous identification of a specific medical device on the market.”3 The UDI iscomprised of the UDI Device Identifier (“DI”) and UDI Production Identifier (“PI”). The DI is
specific to a model of medical device, whereas the PI identifies the unit of device production,such as a serial number, lot or batch number, software version, and manufacturing and/or
expiration date.4
Below we offer our views on important aspects of the FDA’s final UDI rule that should be
adopted when implementing a new UDI system as they are not otherwise covered in the IMDRF
UDI Guidance.

3

IMDRF, UDI Guidance, p. 8.

4

A UDI system is distinct from a “track and trace” postmarket system.

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1.

Utilization of a Phased-In and Risk-Based Approach

An important element of the FDA’s final UDI rule that is not discussed in the IMDRF Guidanceis an implementation scheme that offers a phased-in and risk-based approach. Class III devices(e.g., the highest risk devices) were required to comply with the rule within one year of its
issuance; class II devices that are implantable, life-sustaining or life-supporting were provided
two years to comply; class II devices were provided three years to comply; and class I devices(e.g., the lowest risk devices) were provided five years to comply. The phased-in approachallowed manufacturers to first concentrate their initial UDI compliance efforts on the highest risk
medical devices, allowing such products to be managed throughout the supply chain and inreporting situations in a more expedient manner. FDA was also able to build its infrastructure
incrementally and collaboratively with industry partners during this initial implementation phase.
By granting more time to implement the rules for lower risk products, manufacturers and FDA
were able to work together to clarify certain portions of the UDI rule and provide a more robust
process and solution for implementation which resulted in a more consistent implementationinterpretation and ultimately better data quality, particularly for the GUDID.
Recommendation: UDI rules should offer a phased-in and risk-based implementation approach.
The initial implementation period should begin no less than two years for the highest risk
devices.
2.

Reliance on Standards and Globally Accredited Issuing Agencies

In addition to the IMDRF Guidance, the FDA’s UDI rules and policies rely heavily oninternational standards and globally accredited UDI issuing agencies. This resulted in a leastburdensome approach to implement specific labeling requirements already known and used in
the global healthcare system. In particular, the FDA relied on the following globally accredited
UDI issuing agencies and their associated issuing and use standards for automatic identificationand data capture (AIDC):a) GS1: A globally recognized non-profit organization dedicated to the identification andlabeling of consumer packages. Country-specific GS1 groups exist throughout the world
with more than one million registered users and more than 112 locally-owned offices
globally. GS1 issues bar code standards that medical device manufacturers use on a daily
basis including linear and 2D formats.
b) Health Industry Business Communications Council® (HIBCC): HIBCC is anindustry-sponsored and supported non-profit council, founded in 1983, that develops astandard for data transfer using uniform bar code labeling. HIBCC was founded through6

member organizations covering the Americas and European Union, and issues bar code
formats that historically have been used by hospitals and healthcare organizations.
c) International Council for Commonality in Blood Banking Automation (ICCBBA):ICCBBA is a non-profit association whose goal is the adoption of ISBT 128 for all
medical products of human origin. It enhances patient safety by promoting and managing
the ISBT 128 international information standard used in more than 77 countries across
six continents and is widely endorsed by the professional community.
d) Global Medical Device Nomenclature (GMDN): The GMDN is a system ofinternationally agreed terms used to identify medical devices. The GMDN database
identifies more than 23,000 different medical devices and has been in use for over 16
years, with a high proportion of regulators and manufacturers now familiar with its use.
The database is used by regulators, hospitals and manufacturers to identify medical
devices that are of the same generic type. This supports market surveillance, adverse
event reporting, product recall and other healthcare management activities.
The following international standards were also recognized as valuable in the development of the
FDA’s UDI rule and should be leveraged when developing new UDI rules and policies:a) ISO/IEC 15459, Parts 1-4, 6. Information Technology—Unique Identifiers;b) ISO/IEC 646:1991. Information technology—ISO 7-bit coded character set for
information interchange; andc) ISO 8601:2004. Data elements and interchange formats—Information interchange—
Representation of dates and times.
Recommendation: In addition to the IMDRF Guidance, UDI rules and policies should be basedon international standards and globally accredited UDI issuing agencies, including thosementioned above, and existing organizations that support healthcare supply chains. In addition,
regulators should consider the evolution of UDI technology by adopting technology neutral
regulations.
3.

Access to Information; Submission Methods

The FDA stores UDI data in the GUDID, which can be searched, analyzed and reviewed by thegeneral public.5 The FDA provides manufacturers with multiple modes to interface and enter
data into the GUDID. These include direct web interfaces, submission of data as an XML file inaccordance with HL7 formats, and leveraging existing systems such as the Global Data5

We note that certain confidential data is not displayed to the public in the GUDID. Only the regulator andsubmitter may review this more sensitive data.

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Synchronization Network (GDSN). This flexible approach to data entry allows manufacturers
to adopt business-appropriate solutions, enabling improved implementation speed and data
accuracy. Moreover, recognition of global standardized approaches to data collection, such as
GS1 Standards via the Global Standards Management Process (GSMP), promotes harmonization,
which improves implementation speed, data accuracy and patient safety.
In addition, regulators should leverage a standard set of UDI fields and limit free text. Wheneverpossible, Boolean (yes/no) or numeric field types should be used. If text is necessary, a list ofvalues (LoV) should be considered to allow manufacturers to submit standardized master datathat countries can display in multiple languages by translating the field titles or list of values.
This is especially valuable for countries that have more than one national language.
Recommendation: Manufacturers should be permitted to submit information to databases
using standards-based submission options to account for their variation in size and capabilities,
such as the use of web interfaces, HL7 formats or GDSN.
4.

Providing Assistance to Industry: Help Desk, Training and Guidance

Manufacturers have found that ongoing assistance and interaction from the regulator, such as
help desks, training, and guidance documents, are beneficial throughout the implementation
phase of new UDI rules. In order to assist industry with implementation of the final UDI rule,
the FDA established a help desk, has and continues to hold frequent training opportunities, andissues consensus-based guidance documents on complex and nuanced topics to ensure
consistency of interpretation and maintain data quality. Other regulators should provide similar
assistance when implementing a new UDI system.6a.

Help Desks

The FDA’s UDI Help Desk has proven beneficial to large and small companies, as well as to theagency. The Help Desk is administered through a web-based form, and there are several linked
paths on the FDA’s website to help users arrive at the Help Desk efficiently. The Help Desk
website asks the user to input various identifying information, including contact information.
Responses to simple questions generally are emailed to the requester within a few days. In cases
where the questions or responses are complex, the FDA may take more time and may request
additional information, or even a teleconference. The FDA has done a good job at providing
standardized answers for frequently asked questions helping to align the interpretation of the rule6

The closer a national UDI regulation is aligned with the global standard, the less regulators will be required toassist with these activities because the general principles of the regulation will be already understood.

8

across the industry.7 We have also found it useful when agency experts provide answers to morenuanced questions.
b.

Training

The FDA offered a number of training opportunities throughout the implementation phase of the
final UDI rule, and convenes GUDID user groups in advance of compliance dates, both of whichhave proven useful. Training opportunities may be provided in a conference setting, with both
the FDA and industry serving as speakers during UDI-specific conferences, as well as through
FDA moderated webinars. Conference settings provide more extensive programs with detailed
information and multiple opportunities for participants to collaborate with one another.
Webinars can be offered at no cost to large numbers of participants, and can provide a forum forlive question and answer sessions between the FDA and industry. These interactive methods
have provided widespread collaborative information sharing in which industry shares
experiences and the agency learns about various product labeling and distribution scenarios,
which allow for more consistent interpretation and implementation of UDI rules and definitions.
c.

Guidance Documents

The FDA has issued a number of guidance documents interpreting the regulation. These
documents are invaluable to both the FDA and industry, as they provide detailed information
about the UDI rule and compliance obligations often for complex and nuanced issues. Because
they are not rules, guidance documents can be updated more easily in the future as the FDA andindustry become more fluent about the intricacies of implementing a UDI system.
Taken together, a help desk, training opportunities, and guidance documents are valuable helping
tools for industry as a UDI system is implemented. Regulators benefit as well, because
information exchanges promote greater common understanding of the regulation, which will inturn facilitate continued compliance by industry and create consistency and better UDI data
quality.
Recommendation: Regulators should provide assistance when implementing a new UDI
system, including at least the following:a) Establish a Help Desk that manufacturers can access easily throughout theimplementation period of a UDI rule, and make such responses available to the public.

7

FDA does not currently post answers to Help Desk questions to its website. However, we believe such a practicewould benefit industry and reduce the need for the regulator to respond to duplicative questions.

9b) Offer frequent training opportunities for manufacturers prior to and during the system’s
implementation period, including webinars with question and answer sessions and inperson training events.
c) Issue guidance documents in a timely manner that explain how the agency interpretscomplex and nuanced portions of the UDI rule, and update the guidances as needed.
5.

Exceptions, Exemptions, Alternatives and Extensions

The FDA’s final UDI rule provides a mechanism for manufacturers to request exceptions,
exemptions, alternatives and extensions of time for certain aspects of the rule.8 This element of
the rule has proven important as it enables manufacturers to address directly with the agency
implementation challenges in a positive and constructive manner. We recommend UDI systems
include a mechanism to issue exceptions, exemptions, alternatives and extensions, as well as thefollowing:a) Ensure the request mechanism applies to all aspects of the UDI rule to avoid
administrative challenges in granting appropriate exemptions; andb) Establish an administrative means for quickly communicating and publicallydisseminating request responses that would apply generally to the entire industry, so as to
avoid use of agency resources responding to the same issues with multiple manufacturers.
Recommendation: UDI rules should provide the regulator with an efficient and expedientmechanism to grant exceptions, exemptions, alternatives and extensions that may exist for
specific product areas or for specific manufacturers.

INFORMATION LEARNED WHILE IMPLEMENTING THE UDI RULE

The FDA’s UDI rule provides numerous features beyond the information contained in the
IMDRF UDI Guidance that are beneficial to industry. That being said, as can be expected in arulemaking process that establishes and implements a new regulatory regime, the medical device
industry and FDA learned valuable information during the implementation period. This section
identifies those lessons so that other countries can benefit from this experience as they develop
UDI rules of their own.
FDA’s website lists a number of public exceptions, exemptions and alternatives at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/UDIExceptionsAlt
ernativesandTimeExtensions/default.htm.
8

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1.

Initial Implementation Timelines Should Be Two Years or More

While the FDA’s UDI rule included a phased-in and risk-based implementation scheme, ourexperience indicates that a one year implementation period for the first cohort of products subject
to the rule is not adequate. There were a number of implementation questions that required
clarity from the FDA, and industry did not have sufficient time to coalesce around a standardized
labeling approach. This is particularly true given that device manufacturers must typically
prepare their device labeling as much as one year in advance of a product’s release. Moreover,an initial one year implementation period did not provide manufacturers and FDA with sufficient
time to build a robust IT solution to work with the GUDID.
Recommendation: An initial implementation timeline of at least two years will better permit asmooth transition for the first set of devices subject to the rule. Doing so will provide industry—
and the regulatory agency responsible for UDI implementation—sufficient time to address initial
implementation concerns prior to the first effective date.
2.

Clarify Date of Manufacture When Defining Production Identifier

When the date of manufacture is not used in the traceability or identification of a device because
other means of production identification appear on the device label, it is not necessary to include
it as a required production identifier of the UDI. Including the date of manufacture in the AIDC
(barcode) presents technical challenges, such as redesign of product labels, manufacturing
equipment upgrades, and modification of software applications used in printing labels, label
inspection, and product selection in distribution warehouses.
Recommendation: The device’s date of manufacture should not be a required production
identifier when other means of production identification appear on the device label.
3.

Small Medical Device Exemption

When the UDI rule was published there was insufficient information available to allow for theestablishment of objective criteria to guide manufacturers in deciding when a label was too small
to accommodate a UDI. After experience with the rule and the capabilities of software
applications used in printing labels and label inspection, a general exception for medical devices
that can only accommodate labels with a height of 50 mm or less and, if applicable, a diameter of
30 mm or less is appropriate because the small label size will not accommodate a UDI alongwith other required regulatory label information.

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Recommendation: UDI rules should provide for a general exemption for small medical
devices.
3.

UDI Rules Should Exempt All Devices Manufactured or Labeled Prior to the
UDI Rule Effective Date

In general, devices sold and placed in commerce prior to the UDI rule effective date should be
categorically exempt from the UDI requirements. Many devices have long shelf lives (e.g.,
blood glucose meters and lancets) and may therefore remain in commercial distribution for asignificant period of time. Moreover, numerous healthcare systems rely on consignment
inventory,9 many of which hold such inventory for multiple years. Such devices include but are
not limited to: Non-sterile implant devices distributed in sets, intraocular lenses (IOLs), andvarious active implantable devices (e.g., cardio, neurostimulator) and non-active implants (e.g.,
instruments, heart valves, catheters, stents, and venous closure devices).
It is therefore imperative that any UDI rule fully exempt devices from its requirements that areplaced into commercial distribution prior to the rule’s effective date. Doing so will ensure that asmooth and successful transition to UDI will occur. Locating, removing, storing, and/or
reworking these devices after the UDI compliance date to either re-label or destroy them isunproductive to the healthcare system, and could lead to significant and serious productshortages.
Recommendation: UDI rules should exempt all devices manufactured or labeled prior to the
UDI rule effective date, including those that are held on a consignment basis.
4.

Drive Global Convergence for use of New Product Identifiers

The FDA and globally accredited UDI issuing agencies provide structured rules that
manufacturers must follow to determine when a new device identifier must be used in order toensure they are unique and consistent on a global basis. For example, the FDA requires adifferent device identifier for each version or model of a device.10 Globally accredited UDI
issuing agencies also require manufacturers to use different device identifiers under certain
9

Medical device sets containing a variety of device types and sizes, arranged in a manner to benefit patient care, areconsigned to healthcare facilities to facilitate rapid deployment according to clinical need. The medical device
industry and healthcare providers developed this consignment model for these sets of devices to ensure rapid accessto needed clinical components and mitigate costs to health care facilities. Devices not distributed in sets may also be
consigned to reduce the cost burden to healthcare facilities. This approach facilitates the placement of a vastassortment of device types and sizes within immediate reach of healthcare providers, including devices that arecommonly used and some that are rarely used.
See 21 C.F.R. § 830.40(b) (explaining that “version” or “model” is defined as a device that has specifications,performance, size and composition within limits set by the manufacturer).
10

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circumstances, generally requiring a new device identifier when the customer is expected to
distinguish one product from another.
Given the rapid and iterative innovation cycle of medical devices, not all product changes require
a new device identifier under the FDA’s rules or a globally accredited UDI issuing agency’s
guidance. As a result, manufacturers institute their own individually developed processes within
the context of the given framework established by FDA and globally accredited UDI issuingagencies. These processes are based on internal needs when assigning device identifiers to eachproduct and level of packaging. In this regard, manufacturers are not consistent in the way theyinternally assign device identifiers to each product and package level, particularly for changes toa device that do not trigger a new device identifier under the issuing agency’s guidelines. For
example, a manufacturer may group identifiers as demonstrated below:
Device Model A
Device Identifier 1
Device Identifier 2
Device Identifier 3
In contrast, a manufacturer may also organize device identifiers in a 1:1 relationship to thedevice model number, as demonstrated below:
Device Model A

Device Identifier 1

Device Model B

Device Identifier 2

Device Model C

Device Identifier 3

Criteria for what triggers a new UDI-DI should be globally harmonized to avoid divergences
between regulations and issuing agencies, and also allow sufficient flexibility for manufacturers.
It should also be acknowledged that mergers and acquisitions occur frequently in the medical
device industry. Therefore, UDI database systems should accommodate for transfers ofownership and the variations by which identifiers may be assigned within a given organization.
Similarly, there are many types of third party relationships that exist within the medical device
industry, including suppliers, manufacturers, distributors and service providers. These
relationships are managed through contracts where each party agrees to their responsibilities toultimately manufacture and distribute a medical device. It is important to note that the
manufacturer or supplier of a device may have contracts with multiple entities throughout theindustry. Furthermore, the party that holds the FDA clearance (e.g., regulatory file) is not always
the brand name owner of the labeled device. As such, third party supply chain relationships may
overlap with multiple finished device manufacturers. Therefore, it is important to acknowledge

13that UDI rules must accommodate for and provide flexibility with respect to who bears the
responsibility for compliance with the rules.
Recommendation: It is important to understand the implementation variations that occur
between manufacturers with respect to use of device identifiers and maintain flexibility to
account for a manufacturer’s specific needs by staying within the established framework of the
globally accredited UDI issuing agencies.
5.

Changes to Databases

At times it may be necessary to make changes to the UDI database (e.g., GUDID). Such changes
may include new or amended data fields, entry mechanisms, and codes. Medical device
manufacturers have established procedures and processes, including internal IT systems,
specifically tailored to these databases to automate and streamline data entry. When databasechanges are made, the medical device manufacturer must subsequently update their internal IT
systems as well. These changes can take many months to implement because the new changes
must be translated into local requirements, systems must be re-configured and updated, newsoftware must be validated, quality system changes must be updated and documented, and user
training and remediation plans must be performed.
Recommendation: Changes to a UDI database should be minimized as much as possible.
Implementation timelines related to a UDI database change must account for industry to update
internal systems and processes. This holds true even for what may appear to be a simple change.
Providing adequate time to implement database changes will ensure the data flow remains
accurate and timely.
In addition, system downtime should be published in advance when possible, and allowances
made for submissions when a system’s downtime may have interfered with the applicable
compliance date.
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