FREYR UDI VISION SERIES SESSION 2 - BARCODING & LABELING

FREYR UDI VISION SERIES
PART 2 – Labeling and Barcoding
Date: 21 Nov 2014

Session 2 - Agenda
1. Freyr Fact Sheet
2. UDI Labeling & Barcode Standards
3. RFID in Medical Devices
4. UDI Labeling for Different Device Types
5. Exemptions and Highlights
6. Q&A SESSION 1 – AGENDA
1. Overview - UDI
2. GUDID Components
3. UDI – Master Data Management
4. Freyr Leverage – UDI Expertise
5. Freyr IDENTITY – UDI Software Solution
6. Freyr Corporate OverviewDISCLAIMER: All images, pictures showcased are property of their respective legal owners
(GS1, HIBCC & ICCBBA) and are used for illustrative/ information purposes only.

→ Headquartered in New Jersey, USA with
Regulatory Operations & Data Centre in
Cranbury, NJ, USA
→ Global Regulatory Operations & Development
Centre in Hyderabad, India, Asia’s leading Bio-
Tech Hub with an office in Maidenhead, UK
→ Robust Information Security and Quality ISO
9001 & ISO 27001 Certified Processes with
state-of-the-art infrastructure and BCP & DR
site
→ Best-in-class Regulatory Consulting, Technology
and high-value/ low-cost Outsourcing Services
→ Rapidly growing strong 350+ team of
regulatory, scientific, technology & consulting
professionals
→ Freyr is the preferred partner to Top 10 Fortune
50 Bio-Pharma & Consumer Healthcare and
several Small-Medium Pharma & Life Sciences
Companies.
Freyr, is a fast-growing, Global Regulatory Solutions & Services company with an exclusive focus on the entire
Regulatory value-chain
Freyr Consulting and
Advisory Services
1. Freyr IDENTITY – Stand alone Software for UDI
2. Freyr ACCELERATE - Building custom validated
Enterprise scale applications coupled with Freyr
Identity solution (Custom Bolt-on Solutions)
3. Operational Data Management
UDI READINESS
ASSESSMENT/
GAP ANALYSIS
DI IMPLEMENTATION
& SUBMISSION
MANAGEMENT
LIFE CYCLE
MANAGEMENT
Freyr in the UDI Space
Freyr Fact Sheet

UDI Labeling & Barcode Standards
Presenter : Alan & Prasanna

UDI Representation:
According to UDI final rule, the UDI must appear on every device as device label or direct marking.
It is presented in two forms:
(1) Easily readable plain-text or Human Readable Interpretation (HRI), and
(2) Automatic identification and data capture (AIDC) technology.
Direct Marking (DM):
A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing
the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed
before each use.
The UDI provided through a direct marking on a device may be:
(1) Identical to the UDI that appears on the label of the device, or
(2) A different UDI used to distinguish the unpackaged device from any device package containing the device.
Date Format:
The format is: the year, using four digits: followed by the month, using two digits; followed by the day, using two
digits; each separated by hyphens. For example, January 2, 2014, must be presented as 2014-01-02.
UDI Compliant Labeling

CHALLENGES MITIGATION
• Selection of IA based on
the device type and their
applicability
• Profile the devices and
based on their portfolio
apply to respective IA
• Every device label
marketed by the labeler
needs to be reworked
• Based on the selected IA
the artwork team needs to
redesign the labels
• Inventories of preprinted
stationery of labels
• Plan earlier to avoid
wastage of labels
• Impact of DM (Direct
Marking) on applicable
devices
• DM applicability for
devices needs to be
identified and the
production line must be
equipped with
infrastructure to support
DM requirements. The
production staff must be
trained on the new
infrastructure
Format of the numbering and the standard for AIDC is
mandated by the Issuing Agency (IA).
Every IA has a different set of numbering and AIDC
standards
Industry Challenges
Based on the IA selection, the labeler has to rework the
label format through their artwork and publishing team
to accommodate the UDI in both HRI and AIDC formats
This exercise needs to be done for each and every device
that is marketed by the labeller
This again implies the need to start the UDI compliancy
activity at the earliest

GS1 Labeling Standards
GUDID DataDate Lot
PI
DI
LINEAR SYMBOLOGY
15416:2000 – AIDC techniques -- Bar code print quality test
specification -- Linear symbols
15417:2007 – AIDC - Code 128 bar code symbology specification
15423:2009 – AIDC techniques -- Bar code scanner and decoder
performance testing
15426-1:2006 – AIDC techniques -- Bar code verifier conformance
specification -- Part 1: Linear symbols
15426-2:2005 – AIDC techniques -- Bar code verifier conformance
specification -- Part 2: Two-dimensional symbols
2D SYMBOLOGY
15415:2011 – AIDC - Bar code symbol print quality test specification -
Two-dimensional symbols
16022:2006 – AIDC techniques - Data Matrix bar code symbology
specification
Under GS1, the Global Trade Item Number™ (GTIN™)
is used for the unique identification of trade items worldwide.

GS1 – Barcoding Standards
1 2 3 4
Device Identifier
Expiration Date2
1
Lot number
Serial number4
3
AIDC format: Example using GS1-128:
AIDC format: Example using GS1-Datamatrix:
2
4
3
1

HIBCC Labeling Standards
DI
PI
GUDID
Data
GUDID
Data
LINEAR SYMBOLOGY
15416:2000 – AIDC techniques -- Bar code print
quality test specification -- Linear symbols
15417:2007 – AIDC - Code 128 bar code symbology
specification
16388 – AIDC – techniques – Code 39 bar code
symbology specification
2D SYMBOLOGY
15415:2011 – AIDC - Bar code symbol print quality test
specification - Two-dimensional symbols
16022:2006 – AIDC techniques - Data Matrix bar code
18004:2006 – AIDC – techniques - QR Code bar code
24728 – AIDC techniques – MicroPDF417 bar code
24778 – AIDC techniques -- MicroPDF417 bar code
Labeler identification Code (LIC) is assigned by HIBCC and it Identifies the
labeler.

HIBCC - Barcoding Standards
Primary and Secondary Data in a 2D Symbol
HIBC LIC Secondary Code Data Structure
+A99912345 / $$59901510X3J
53 22 98761 4
+A99912345 / $$59901510X3J
53 22 98761 4
HIBC Supplier Labeling flag
LIC2
1
Product ID3
5
4
6
7
8
Unit of Measure
Data delimiter
Exp. Date Flag
Expiration Date
Lot Number
9 Check Character

ICCBBA Labeling Standards
GUDID
Data
GUDID
Data
LINEAR SYMBOLOGY
15416:2000 – AIDC techniques -- Bar code print quality
test specification -- Linear symbols
15417:2007 – AIDC - Code 128 bar code symbology
specification
2D SYMBOLOGY
15415:2011 – AIDC - Bar code symbol print quality test
specification - Two-dimensional symbols
16022:2006 – AIDC techniques - Data Matrix bar code
ISBT 128 is the global standard for the terminology, identification, labeling, and information transfer of medical products of
human origin (including blood, cell, tissue, and organ products) across international borders and disparate health care systems.

ICCBBA - Barcoding Standards
Issuing
Agency
Data
Delimiters Identifier Data type
Human Readable Barcode
Field Size
Database
Field Size
ICCBBA =/ DI Alphanumeric 18 16
ICCBBA =, Serial Number Alphanumeric 8 6
ICCBBA = Donation Identification Number Alphanumeric 16 15
ICCBBA => Expiration Date numeric [YYYJJJ] 8 6
ICCBBA =} Manufacturing Date numeric [YYYJJJ] 8 6
ICCBBA &,1 MPHO Lot Number Alphanumeric 21 18
Ex of Human Readable Barcode:=/A9999XYZ100T0944=,000025=A99971312345600=>014032=}013032&,1000000000000XYZ123
ISBT 128-Linear Barcode
2 53 41
Facility identification code
Year of collection-donation
3
1
Serial number
2
5
4 Flag character-turned 90⁰
Check digit

RFID in Medical Devices
Presenter : Alan

Radio Frequency Identification (RFID)
RFID has the potential in healthcare to achieve improvements in both supply chain productivity and patient
safety applications.
The ISO approach to RFID implementation is based upon healthcare product supplier migration from existing
barcode or 2-D symbologies to RFID.
Barcoding will continue to be used in the future, and will co-exist with RFID. As with all technologies, each will
be utilized in the functions for which it offers the highest benefit/cost ratio and comparative advantage.
RFID utilizes data chips that do not have to be visible to be scanned. RFID tags are unique serial numbers that
allow tracking of the lowest unit of measure that is tagged.
The volume of data contained within RFID tags is dependent on size and type, containing up to 128 kilobytes
of data.
An RFID tag can be one-time use or re-useable. RFIDs are the most expensive of the barcode options.
RFID technology enables manufacturers of reprocessed or reusable medical devices to comply with the direct
part marking requirement of the FDA Final Rule for UDI.
ISO/IEC 15418 (Incorporating ANS MH10.8.2 Data Identifiers), and ISO/IEC 15961, 15962 and 15963 are
normative references for UDI RFID data protocols.

RFID Visibility to UDI Inventory
Device
Manufacturer
3 PL or DC
Hospital
or Medical
Facility
RFID Event
LEAVE_MANUFACTURER
RFID Event
ARRIVE_DISTRIBUTION
UDI ‘SmartLabels’
on Packaging Known ‘PI’ Inventory at
Customers location
RFID Event
Management
Software
EventData
RFID Event
ARRIVE_CUSTOMER
UDI RFID Deployment
in Supply Chain
Track &
Trace
Customer Enterprise

Presenter : Prasanna
UDI Labeling for Different Device Types

Single Use Devices
Single-use devices (SUDs) come under an exception of not having an UDI, provided that:
• The UDI appears on the device package
• All SUDs of a single version/model are distributed together in a single device package
• They are to be stored in that device package until removed for use
• They are not meant for individual commercial distribution
• Implants that fall under SUDs do not have this exception
If the devices are intended for individual commercial distribution, the device label and
package for these individual devices is required to bear a UDI
Single-use devices that are implants which are subjected to additional processing and
manufacturing are exempted from having a permanent UDI on the device

Combination Products / Kits
Combination products are required to have an UDI, however the device constituent part of that
combination product or kit are exempt from the UDI requirement. Combination products include;
Convenience Kits, in-vitro diagnostic kits, and HCT/Ps, etc.
Each component, sub-system or accessory that is considered a medical device and is commercially
available needs a separate UDI unless the components are part of a convenience, medical
procedure, IVD kit or configurable medical device system that is marked with its own UDI.
If the combination product instead has an NDC code, it is exempt from the UDI requirements
however in that case, the device constituent part must have the UDI unless the product is a single
entity combination product where the drug/device are physically, chemically or otherwise
combined.

Stand-Alone Software
The UDI Rule does not provide any special requirements for a device that contains software as a
component of the device, but does require stand-alone medical software to be labeled with a UDI.
All stand-alone software, whether packaged or unpackaged (e .g., software downloaded from a
website), must provide its UDI through either or both of the following:
• An easily readable plain-text statement displayed whenever the software is started
• An easily readable plain-text statement displayed through a menu command (e.g., an
“About...” menu command)
Stand-alone software that is distributed in packaged form is subject to the same UDI labeling
requirements as any other medical device -- the device label and device package must bear a UDI in
plain-text and AIDC formats.
Stand-alone software that is distributed in both packaged and unpackaged form may be identified
with the same DI. Stand-alone software that is not distributed in packaged form must convey the
version number in its production identifier.

Exemptions and Highlights
Presenter : Alan

General Exemptions
Single Use Device Exception (multiple in 1 Package, any class/except implants): UDI required on device package,
not required on device label.
Class III Extension +1 year, if request is approved.
GMP exempt Class I devices are exempt completely from the UDI requirements; however, the standardized date format
requirement still applies.
Single-use contact lenses are subject to the exemption from the need to be individually labeled with a UDI under
§ 801.30(a)(3).
Boxes or containers used explicitly for shipping and transportation are exempted from UDI requirements
Direct marking is now only required for devices that are reusable i.e. device intended to be reprocessed before each use.
There are provisions for exemptions from direct marking if the marking would affect the device safety or effectiveness or if
it is technologically not feasible.
Device constituents which are part of the combination product or kit and not commercially available are exempt from the
UDI requirement.
A Medical device used solely for research, teaching, or chemical analysis, and not intended for any clinical use.
Veterinary medical device need not to have a UDI.
PI attribute information is optional for Class-I devices

Medical Device in Inventory
UDI requirements apply to devices placed into commercial distribution after the compliance date that
applies to the device.
A finished device manufactured and labeled prior to its compliance date and held in inventory is
excepted from UDI requirements for three years after the compliance date.
This exception applies to both products held in inventory by the labeler and those consigned to a
hospital or other potential purchaser and held in inventory, but not yet purchased, by the potential
purchaser.
This exception applies to all UDI requirements.

Implantable Devices
The UDI Rule does not require an implantable device to be directly marked with its UDI.
CDRH believes that the UDI label and package requirements will provide for adequate identification of an
implantable device up to the point where it is implanted.
CDRH also acknowledges the common practice of recording information about implanted devices both in the
patient's health record (EHRs and PHRs), and on a card provided to the patient, and they expect health care
providers will incorporate UDIs into both of these types of records.
UDI – Small Labels
The final rule does not specify the type of label that is required to bear a UDI. It is up to the labeler to determine an
appropriate method to apply the UDI to the device label. An add-on label, in some instances, may be appropriate.
However, a UDI must be included on the device label and every device package.
Device labels not able to accommodate both AIDC and HRI should “Request for an Exception from or Alternative to a
Unique Device Identifier Requirement—Proposed § 801-35; § 801.55 of the Final Rule.”

Questions?
Please Post
Questions
in the
Questions
Panel

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Thank You!

FREYR UDI VISION SERIES SESSION 2 - BARCODING & LABELING

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