On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.

1. Global Regulatory Solutions & Services
FDA Unique Device Identification Mandate for
Medical Devices
The FDA UDI Regulation will enact a single device
identification system that is uniform, univocal,
standardized, and globally coordinated. All Medical
Device companies will be required to comply with
the new UDI approach. While manufacturers stick to
the UDI regulations, they will also have to exploit on
the advantages of streamlining procedures through
uniquely identifying and improving patient safety,
attributions and procedures.
ISSUING AGENCIES
FDA recognizes three agencies (GS1, HIBCC
and ICCBBA). Manufactures have to obtain
the UDI from one of these agencies. Also
Labelers have option to choose the type of
AIDC (Automatic identification and data
capture) technology. Agencies accept ISO
15459 series of standards.
The European Commission (EC) has announced the release of its
recommendation on a framework for a unique device identification (UDI)
system for medical devices marketed in the European Union1
FDA – UDI Mandate
On September 24, 2013, the Food and Drug Administration (FDA) issued the Unique
Device Identification (UDI) System Final Rule2, which establishes a system for adequately
tracking and identifying medical device adverse events and safety issues through
distribution and use within United States. Medical devices that are presumed critical are
subject to this mandate, starting with the most critical (Class III) and ending with least
critical (Class I) devices.
1
See European Commission, common framework for UDI for medical devices for more information
2 See
U.S. Food and Drug Administration (FDA), Unique Device Identification (UDI) final rule at Federal Register for more information.
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2. Global Regulatory Solutions & Services
What is UDI ?
The UDI is a unique combination of numeric or
alphanumeric codes —in both a human-readable
form and a machine-readable form, that includes a
device identifier (DI) which is specific to a device
model, and production identifier (PI), which includes
the current production information for that particular
device, such as the lot or batch number, the serial
number, expiration date, device make and model,
etc. A unique UDI must be applied to the “base
package” and higher levels of packaging. Product
data for all medical devices must be submitted and
kept up to date in an FDA-managed Global Unique
Device Identification Database (GUDID).
Benefits of UDI
 Increase in patient safety through reporting
of adverse events, hereby reducing
medical errors.
 Imparting a standardized identifier that will
assist manufacturers, distributors and health
authorities to manage device recalls more
efficiently.
 Improvising Post-Market Surveillance system
for continued safety and effectiveness.
 Increase in efficiency of Supply Chain
process through proper addressing of
fraudulent medical devices.
 Implementation of a centralized repository of
medical devices, accessible to consumers
leading to a globally recognized medical
device identification system.
UDI Implementation Timelines?
The implementation timelines for UDI are based on the level of risk the medical device
has, starting from Class III to Class I. However, many low-risk medical devices will be
exempt from some or all of the requirements of the Final Rule3.
3 See
U.S. Food and Drug Administration (FDA), Unique Device Identification (UDI) final rule at Federal Register for more information.
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3. Global Regulatory Solutions & Services
Are you Ready for the Challenge ?
Enforcing UDI for medical devices is not an ordinary challenge. Now that
the mandate has been passed, medical device manufacturers have to
meet the final UDI guideline and ensure the following activities are
carried out effectively:
Collection, Conversion and Submission of UDI
data to GUDID.
 Timely review and approval of all UDI data
through auditing internal processes.
 Create new submissions for all product versions
and variants.
 Update submissions for changed products.
 Track FDA responses, including approvals,
rejections, product recalls, etc.
 Developing recordkeeping and reporting policies
and procedures.
 Comply with similar global UDI regulations
coming soon from various regional markets.
Freyr Roadmap to UDI Compliance
Keeping the timelines in mind, Freyr’s roadmap to help medical device companies
to UDI Compliance consists of a 3-Step Process. This process signifies Freyr’s
dedication to assist and support medical device companies to attain industry
compliance.
UDI READINESS
ASSESSMENT
UDI Awareness
GAP Analysis
Recommendations
Integrate Project
Planning
DATA
MANAGEMENT
DATA
SUBMISSION
UDI Data
Conversion
Gateway setup
HL7 SPL
Compliance
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Submission to
GUDID
Life Cycle
Management
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4. Global Regulatory Solutions & Services
Freyr Leverage
 2 - 4 Week UDI Readiness Assessment
 Complete GAP Analysis to meet project’s objectives
 Developing an effective roadmap for UDI implementation
 Adept Data Management (collection, collation, validation and conversion)
 Preparation and UDI Submission Status Reports
 Support for current and future submissions with 360° lifecycle maintenance
 Centralized repository for audit requests and regulatory submissions
 Creating validated HL7 SPL Submission Packages, 21 CFR Part 11 compliant
If perfectly brought into play, the UDI data generated will be useful in analytics and
research studies across various industries, academics, and health authorities,
providing a better understanding of device use and achieved patient outcomes.
Freyr Facts
Freyr is a Progressive, Fast-growing, Global Regulatory Solutions & Services company, focusing
exclusively on the entire Regulatory value-chain of Life Sciences companies.
Headquartered in New Jersey, USA with
Regulatory Operations and Data Centre
in Cranbury, NJ, USA.
Global Regulatory Operations & Development
Centre in Hyderabad, India, Asia's leading BioTech Hub.
Rapidly growing strong 200+ team of
regulatory, scientific, technology and
consulting workforce.
Multi-year, successful engagements with Top 10,
Fortune 50 Pharma/Consumer and SmallMedium Life Sciences companies providing bestin-class Regulatory Consulting, Technology and
high-value/low-cost
Offshore
Outsourcing
Services
Management team with a rich background and
global experience in regulatory, life sciences,
business
operations,
and
information
technology, driving global vision and
innovation
All systems and processes are 21 CFR Part 11
Compliant. Quality Management System – ISO 9001
certified. State-of-the-art Infrastructure with ISO
27001 certified information security management,
and robust BCP & DR site.
Management focus to embrace and seriously
contribute to going Green in Social Responsibility
initiatives; well integrated and part of company's
DNA.
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