a global prespective on unique device …what is udi ? udi system is intended to provide a single,...
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A GLOBAL PRESPECTIVE ON
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 and, its key attributes.
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.
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.
IMDRF’S ROLE IN UDI
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
2 Parts in UDI
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.
BREAKING DOWN THE UDI SYSTEM
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.
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.
COMPARISON OF THE GLOBAL STANDARDS
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
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
STATUS OF UDI IN DIFFERENT COUNTRIES
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