A GLOBAL PRESPECTIVE ON UNIQUE DEVICE …

1 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.

2 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.

3 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. UDI-DI ( DEVICE Identifier) UDI-PI (Production Identifier). The UDI-DI is a UNIQUE numeric or alphanumeric The Production Identifier is a numeric or code specific to a model of medical DEVICE . alphanumeric code that identifies the unit of Each component, sub-system or accessory that is DEVICE production considered a medical DEVICE and is commercially The different types of Production Identifier(s).

4 Available needs a separate UDI unless the include serial number, lot/batch number, components are part of a convenience, medical Software as a medical DEVICE (SaMD) version and procedure, IVD kit or configurable medical DEVICE manufacturing and/or expiration date. system that is marked with its own 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. COMPARISON OF THE GLOBAL STANDARDS. GS1 HIBCC ICCBBA. Globally accepted standards DEVICE GTIN HIBC-LIC ISBT-28 PPIC. Identifier ( GLOBAL (Labeler (Processor (UDI-DI) Trade Item Identificatio Product Number) n Code) Identification GS1 Code).

5 Production Application Flag For PI (Product Identifier Identifier Characters + Identifier) one (UDI-PI) (AI) HIBC UDI or more becomes a format for elements of HIBCC ICCBBA part of PI PI. ISBT 28 Data Structure can be used. STATUS OF UDI IN DIFFERENT COUNTRIES. Country Year Standard Label Requirements Data Reporting (UDID). Japan 1999 GS1 DEVICE Identifier, Production Identifier to Unit of Use MEDIS: Reimbursement MHLW. Spain 2006 GS1 DEVICE Identifier, Production Identifier to Unit of Use Reimbursement SAS Department of Health Andaluz Turkey 2009 GS1 & DEVICE Identifier, Production Identifier to Unit of Use TITUBB: Reimbursement HIBCC SGK Social Security Institure USA 2013 GS1, HIBCC DEVICE Identifier, Production Identifiers US FDA GUDID.

6 & ICCBBA. Argentina 2014-15 GS1 DEVICE Identifier, Production Identifiers and GLOBAL Location ANMAT DEVICE Track and Numbers (GLN) Traceability EU 2015/20 GS1, HIBCC DEVICE Identifier, Production Identifier to Unit of Use EU Common Eudamed Database 16 & ICCBBA. Canada 2016 GS1, HIBCC Follow IMDRF. & ICCBBA. STATUS OF UDI IN DIFFERENT COUNTRIES. Country Year Standard Label Requirements Data Reporting (UDID). Turkey 2017 GS1 DEVICE Identifier, Production Identifier to Unit of UTS Tracking Imported Use devices from Customs to Customer China TBD International (GS1) and DEVICE Identifier, Production Identifier to Unit of National (?)

7 Use Brazil TBD GS1, HIBCC & ICCBBA Follow IMDRF. S. Korea TBD TBD TBD. Singapore TBD TBD TBD. Saudi 2018 GS1, HIBCC & ICCBBA DEVICE Identifier, Production Identifier to Unit of SFDA UDI Database Arabia Use Taiwan GS1, HIBCC & ICCBBA DEVICE Identifier, Production Identifier Oman 2017 GS1 DEVICE Identifier, Production Identifier UDI IN USA. 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 EUROPE. European Commission final rule released in June 2016.

8 Publication in Official Journal of EU (expected Dec 2016/Jan 2017). UDI implementation 3 years after entry into force. EU MDR UDI Compliance Timelines Objectives: Add for Direct Develop a standardized system UDI in MDR Regulation Marking Application Compliance of (UDI). Class III &. Placing UDI in Human Readable Implantable 1 Year + 2 Years and AutoID formats on label, DEVICE or both. Class IIa Register UDI Data in Eudamed Database. Class IIb 3 Years + 2 Years Class I 5 Years + 2 Years UDI IN CANADA. 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).

9 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 TURKEY. All reimbursable medical devices must be identified and marked with GTIN or HIBC. Approximately 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.

10 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 CHINA. 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 , , China medical DEVICE nomenclature (CMDN) CMDN. developed and already assigned CMDN to 20% of devices UDI IN TAIWAN.