AN OVERVIEW OF GLOBAL

UNIQUE DEVICE IDENTIFICATION (UDI)

WHAT IS UDI ?

▪UDI System is intended to provide a single, globally harmonized system for

positive identification of medical devices.

▪Healthcare professionals and patients will no longer have to access multiple,

inconsistent, and incomplete sources in an attempt to identify a medical device

▪ There are currently no global definitions of what constitutes a UDI or UDI

System discrepancies between different national approaches do exist and

will most likely increase.

▪Common globally harmonized UDI System requirements would offer significant

benefits to manufacturers, healthcare providers, patients, and regulatory

authorities.

IMDRF’S ROLE IN UDI

▪UDI working group was established in October, 2008 under Global

Harmonization Task Force (which is now a part of IMDRF).

▪ The final version of IMDRF Guidance on UDI for Medical Devices was released

on December 9, 2013.

▪ This guidance provides a framework for those regulatory authorities that intend

to develop their UDI Systems that achieves a globally harmonized approach to

the UDI.

▪ The framework can be used at a local, national, or global level such that these

systems are implemented without regional or national differences.

BREAKING DOWN THE UDI SYSTEM

Three major parts:

1. The development of the UDI using globally accepted standards.

2. The application of the UDI on the label.

3. The submission of appropriate information to a UDID (Unique Device

Identification Database), which contains identifying information and other

elements associated with the specific medical device.

BREAKING DOWN THE UDI SYSTEM

The UDI must be present in AIDC (Automatic Identification and Data Capture) such as bar-codes, biometrics, RFID etc., and HRI (Human Readable Interpretation) format.

UDI-DI (Device Identifier) UDI-PI (Production Identifier)

▪ The UDI-DI is a unique numeric or alphanumeric code specific to a model of medical device.

▪ 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

▪ The Production Identifier is a numeric or alphanumeric code that identifies the unit of device production

▪ The different types of Production Identifier(s) include serial number, lot/batch number, Software as a Medical Device (SaMD) version and manufacturing and/or expiration date.

2 Parts in UDI

COMPARISON OF THE GLOBAL STANDARDS

GS1 HIBCC ICCBBA

DeviceIdentifier (UDI-DI)

GTIN (GlobalTrade Item Number)

HIBC-LIC(Labeler Identification Code)

ISBT-28 PPIC (Processor Product Identification Code)

Production Identifier (UDI-PI)

Application Identifier (AI) becomes a part of PI

FlagCharacters + HIBC UDI format for PI.

For PI (Product Identifier) one or more elements of ISBT 28 Data Structure can be used.

GS1

ICCBBAHIBCC

Globally accepted standards

Country Year Standard Label Requirements Data Reporting (UDID)

Japan 1999 GS1 Device Identifier, Production Identifier to Unit of Use MEDIS: ReimbursementMHLW

Spain 2006 GS1 Device Identifier, Production Identifier to Unit of Use ReimbursementSAS – Department of Health Andaluz

Turkey 2009 GS1 & HIBCC

Device Identifier, Production Identifier to Unit of Use TITUBB: ReimbursementSGK – Social Security Institure

USA 2013 GS1, HIBCC & ICCBBA

Device Identifier, Production Identifiers US FDA GUDID

Argentina 2014-15 GS1 Device Identifier, Production Identifiers and Global Location Numbers (GLN)

ANMAT Device Track and Traceability

EU 2015/2016

GS1, HIBCC & ICCBBA

Device Identifier, Production Identifier to Unit of Use EU Common Eudamed Database

Canada 2016 GS1, HIBCC & ICCBBA

Follow IMDRF

STATUS OF UDI IN DIFFERENT COUNTRIES

STATUS OF UDI IN DIFFERENT COUNTRIES

Country Year Standard Label Requirements Data Reporting (UDID)

Turkey 2017 GS1 Device Identifier, Production Identifier to Unit of Use

UTS – Tracking Imported Devices from Customs to Customer

China TBD International (GS1) and National (?)

Device Identifier, Production Identifier to Unit of Use

Brazil TBD GS1, HIBCC & ICCBBA Follow IMDRF

S. Korea TBD TBD TBD

Singapore TBD TBD TBD

Saudi Arabia

2018 GS1, HIBCC & ICCBBA Device Identifier, Production Identifier to Unit of Use

SFDA UDI Database

Taiwan GS1, HIBCC & ICCBBA Device Identifier, Production Identifier

Oman 2017 GS1 Device Identifier, Production Identifier

▪UDI Final Rule published on 24th September 2013.

▪Objectives:

• Develop a standardized system

of unique device identifiers (UDI)

• Placing UDI in Human Readable

and AutoID formats on label, device

or both.

• Register UDI Data in FDA public

database GUDID.

UDI IN USA

▪ European Commission final rule released in June 2016

▪ Publication in Official Journal of EU (expected Dec 2016/Jan 2017).

▪UDI implementation 3 years after entry into force.

▪Objectives:• Develop a standardized system

of (UDI).

• Placing UDI in Human Readable

and AutoID formats on label, device or both.

• Register UDI Data in Eudamed Database.

EU MDR UDI Compliance

Timelines

UDI in MDR

Add for

Regulation

Application

Direct

Marking

Compliance

Class III &

Implantable 1 Year + 2 Years

Class IIa

Class IIb 3 Years + 2 Years

Class I 5 Years + 2 Years

UDI IN EUROPE

▪ In the drafting stages of considering how a UDI system may be implemented in Canada. A draft UDI document will be developed for industry over the next year or two (2016/2017).

▪ Implementation of any UDI-specific requirements would only be considered after industry stakeholders have had an opportunity to comment on the draft UDI document.

▪ Expect alignment on IMDRF UDI framework.

UDI IN CANADA

▪ All reimbursable medical devices must be identified and marked with GTIN or

HIBC. Approximately 2.5 million approved medical devices in the Turkish

TITUBB database (~92% GTIN)

▪ MoH is working on a new project “UTS” (a device tracking system) which will

replace current TITUBB system.

▪ Main goal is to track devices from manufacturing facility to end customer.

▪ Workshops with the industry to collect and give feedback to build the new

system starting in September 2015.

▪ New UTS system is planned to go live in June 2017.

▪ Requirements for Direct Marking and 2D Bar Code symbology are under

discussion.

UDI IN TURKEY

▪ CFDA UDI draft rule review with industry 2015. Expect comment period after

public release of the Draft Rule.

Continuing Discussion:

▪ Acceptance of global UDI standard and National Code?

▪ CFDA may consider acting as the issuing agency for National Code.

▪ UDI database approach in China similar to that of US FDA.

▪ Use of Global Medical Device Nomenclature (GMDN) and a national

nomenclature, i.e., China Medical Device Nomenclature (CMDN) CMDN

developed and already assigned CMDN to 20% of devices

UDI IN CHINA

▪ Taiwan FDA UDI Guidance published on October 30, 2015.

▪ Implementation is voluntary.

▪ Provides references to US FDA UDI Rule and IMDRF UDI Guidance.

▪ References to using the same Issuing Agencies and format for UDI as US FDA

and IMDRF, i.e., GS1, HIBCC, ICCBBA.

UDI IN TAIWAN

▪ Regulation Draft released on June 2015 and provided 180 days

implementation.

▪ GTIN, Batch/Lot, Serial, and UBD required in a 2 dimensional bar code on

primary, secondary and tertiary packing level.

▪ Device data hierarchy to be loaded into database portal of the Central

Government.

UDI IN INDIA

▪ Aligned with US FDA and

IMDRF UDI Requirements.

▪ Data Submission web-based

and use of HL7 SPL

(Structured Product Labeling)

UDI IN SAOUDIA ARABIA

▪ ANMAT Regulation on Traceability requires tracking and reporting from manufacture through the supply chain, into the hospital and to the patient. GS1 Global Location Number (GLN) is used for tracking movement locations.

▪ The Track and Trace implementation requires Serialization of all devices notified in the implementation.

▪ Deadlines:

– February 2015: Defibrillators/cardioverters, electric stimulators for cochlear hearing, intraocular lenses, cardiac pacemaker, breast internal prosthesis;

– August 2015: Vascular coronary endoprosthesis (stent), hip prosthesis and column prosthesis.

UDI IN ARGENTINA

▪ ANVISA committed to follow IMDRF.

▪ Draft UDI legislation to be available for public consultation.

▪ University in Brazil working with ANVISA discussing the classification of

medical devices with the assistance of GS1 Brazil.

▪ Discussions on appropriate use of GMDN continue.

UDI IN BRAZIL

COMPARISON BETWEEN UDI IN US/IDMRF/EU

COMPARISON BETWEEN UDI IN US/IDMRF/EU

▪ UDI will be a global phenomenon in the coming decade.

▪ All Medical Devices/IVD’s will need to have an UDI, at every level of

packaging.

▪ Already many countries have implemented an UDI system.

▪ UDI regulations are in the final phase of adoption in major markets, and these

laws will have strict compliance deadlines.

▪ For Medical Device/IVD Companies selling devices in foreign countries, it

would be in the best interest to get familiar with the regional regulations

pertaining to UDI.

CONCLUSION