Medical Device Unique Device Identification (UDI)

Experienced UDI Data Submission to Global Health Authorities

Easily maintain a source data set and provide accurate product data to regulatory authorities and customers

Reed Tech is a leading FDA supplier of Unique Device Identification (UDI) information, submitting close to one-quarter of all NLM Access GUDID UDI records annually. With SingleSource™ for Medical Devices, UDI data is managed throughout the product lifecycle in a compliant SaaS environment and includes scalability for additional volume and global health authorities. Reed Tech has active UDI channels for US FDA, China NMPA, South Korea MFDS and staging for EU EUDAMED.

Global UDI Summary by Region

Below is a high-level summary of UDI related activities by region. It includes UDI plans and timelines for various regulatory authorities and commercial trading partners. As the number of global entities requiring medical device UDI database information grows, Reed Tech will add selectable channels for data submission to regulatory bodies and data syndication to commercial trading partners. Strategic product data management supported by a deep understanding of medical device regulatory and user UDI data requirements will ultimately contribute to improved outcomes for both healthcare providers and patients.

 

GLOBAL UDI REQUIREMENTS BY REGION

UDI Global Placeholder
UDI Global
Australia (TGA)
  • 2019 Jan – UDI system proposal
  • 2020 Sept – UDI Consultation Survey
  • 2021 Feb – Therapeutic Goods Amendment (TGA) establish AusUDID
  • TBD – Phased UDI data reporting, not before EU dates (+1 yr?)

 

  • Approach: similar to EU regulation; UDI/Device registration and UDI labels implemented by MD and IVD classes
  • UDI Data: ‘EU-like’ attributes reported to AusUDID
  • UDI Label: HRI & AIDC; Direct Mark
  • STD: GS1/HIBCC/ICCBBA, EMDN/GMDN?
  • Info: TGA Medical Device & IVD
Brazil (ANVISA)
  • 2020 Jun – UDI Barcode inserts required in a few implant product packages; UDI dat reported to RNI by healthcare provider
  • 2021 Feb  – UDI System Publication
  • 2023? – Class IV (highest-risk) devices
  • 2024? – Class III (high-risk) devices
  • 2025? – Class II (moderate-risk) devices
  • 2027? – Class I (low-risk) devices

 

  • Approach: Pilot started with package UDI barcodes on Coronary Artery Stents and Hip & Knee Arthroplasty Implants
  • UDI Data: Few attributes reported by healthcare provider to National Implant Registry (RNI)
  • UDI Label: DI, Expiry Date, Lot/SN in AIDC (1D or 2D barcode) on (3) Mfr-supplied “Traceability Labels” with product pkg
  • STD: GS1/HIBCC
  • Info: ANVISA (National Health Surveillance Agency)

Canada (Health Canada)

2021? – Expected Health Canada UDI Notice

Approach: Ongoing UDI preparation, expected to follow IMDRF UDI recommendations

China (NMPA)
  • 2019 2H – UDI Pilot, Rules, UDID database tests
  • 2019 Sept 17 — Batch 1 Notice timing and list
  • 2020 Sept 30 – Batch 1 Delay and 69 (64+5) categories
  • 2021 Jan 01 – Batch 1 UDI Data & Label Required
  • 2022 Mar 01 – Batch 2 (Remaining Class III)
  • TBD – Class II
  • TBD – Class I and Remaining Devices
European Union (EC)
  • 2020 Dec 01 —Actor  Voluntary Economic Operator Registration
  • 2021 May 26 – Medical Devices DoA for MDR, Class I Self-Certification
  • 2021 Sept end – UDI/Device Voluntary Registration
  • 2022 May – EUDAMED Launch (fully functional notice)
  • 2022 May 26 – IVD Devices DoA
  • 2022 Nov 26 – Legacy, MD, IVD Required Regs start
  • 2024 May 26 – Legacy, MD, IVD Required Regs deadline

 

  • Approach: MDR/IVDR revamped regulatory framework; register device/UDI data and apply UDI to labels per Legacy, MDR, IVDR rules and timing
  • UDI Data: 109 attributes to EUDAMED; New BUDI-DI group concept
  • Data Sub: Website entry/upload or electronic XML (via Data Exchange) to EUDAMED
  • UDI Label: HRI & AIDC by class (III-2021, IIa/b-2023, I-2025); Direct Mark by class (Label + 2yr)
  • STD: GS1/HIBCC/ICCBBA/IFA; SRN; EMDN
  • Info: EC Reg, UDI (European Commisssion)

 

India (CDSCO)

2022 Jan 01 (To be confirmed) – UDI Placed on Labels (may be delayed due to COVID)

 

  • Approach: Start with UDI on Medical Device Labels’ future expansion with UDI registration database
  • Info: CDSCO (Central Drugs Standard Control Organization)
Japan (PMDA)

2008 Mar – Guideline for Barcode Labeling

2019 Dec 04 – PMD Act required barcode lables and registration

  • Approach: Report device info to database and apply barcode to labels for medical devices and IVDs; future UDI reporting to UDI database
  • UDI Data: device reistration includes: Product Code (DI), Expiry Data, Lot #, Serial #
  • UDI Label: HRI and AIDC (1D GTIN-128 barcode symbol or 2D); no Direct Marking now
  • STD: GS1
  • Info: PMDA (Pharmaceuticals and Medical Devices Agency)
NHS England
  • 2017 Sep – Class III Devices
  • 2018 Sep – Class IIa/b Devices
  • 2019 Sep – Class I Devices
  • 2021 Sep – Class A, B, C, D IVD Devices

  • Approach: Product Data Publication & UDI Label; PEPPOL network for Procurement Data (slow adoption)
  • UDI Data: ~60 attributes
  • Data Sub: GDSN (product); PEPPOL (orders)
  • UDI Label: HRI & AIDC; Direct Mark
  • STD: GS1 only (GTIN and GDSN required)
Netherlands
  • 2018 July – Mfr apply UDI on label of Inclusion List products
  • 2019 Jan 01 – National Implant Registry (LIR) started
  • 2020 Jan – Healthcare providers must register patient implant data in Dutch National Implant Registry (LIR) referencing UDI product data published by Mfr in the “GS1 Data Source”
  • 2020 Jan 01 – By implication Mfr required to report UDI data to GS1 Data Source and apply UDI on label of Inclusion List products

  • Approach: Start UDI prior to EU timeline with devices on “Inclusion List” (~500 Class III and IIb implants)
  • UDI Data:  9 basic (~50 GDSN) attributes
  • Data Sub: Website entry or electronic GDSN to “GS1 Data Source”
  • UDI Label: HRI & AIDC (1D or DataMatrix); include ID (and Lot #, Expiry Date, Serial # as req’d)
  • STD: GS1/HIBCC/ICCBBA
  • Info: Dutch National Implant Register (LIR)
Saudi Arabia (SFDA)
  • 2019 Apr 08 – UDI Draft Requirements released
  • 2019/2020 – UDI Pilot
  • 2020 Sep 06 – UDI Formal Requirements (v.3) released
  • 2022 Aug 01 –  Class D (High Risk)
  • 2023 Feb – Class B & C (Medium Risk)
  • 2024 Feb – Class A (Low Risk)
  • +1 year? – Direct Mark Required
Singapore
  • 2022 High-risk implantables (3)
  • 2024 Class D (High-risk)
  • 2026 Class B (Medium-risk)
  • 2028 Class B (remaining)
  • Voluntary Class A (low-risk)
South Korea (MFDS)
  • 2018/2020 – Guidelines for Barcodes & UDI Codes
  • 2019 Jul 01 – Class IV Devices UDI Labeling req’d
  • 2019 Oct – Class IV Devices UDI Labeling req’d
  • 2020 Jul 01 – Class III Devices
  • 2021 Jul 01 – Class II Devices
  • 2022 Jul 01 – Class I Devices
  • +1 year – Monthly Supply Report Req’d

 

 

  • Approach: UDI data reporting and UDI Label by class AND submit Supply Report (Track & Trace) of ~10 distribution metrics each month
  • UDI Data: 40attributes to IMDIS (Integrated Medical Device Information System)
  • Data Sub: website XLS upload /complete data / upload file or machine-to-machine XML transfer via API by Local Rep
  • UDI Label: HRI & AIDC, Direct Mark
  • STD: GS1 (default), HIBCC & ICCBBA (special)
  • Info: MFDS, IMDIS UDI System
Taiwan

Events

  • 2015-10-30: Administrative Guidance
  • 2020-11-05: UDI Announcement

Compliance Timing

  • 2021-June-01 Class III Implantables
  • 2022-June-01 Class III Implantables
  • 2023-June-01 Class III Implantables

Description

  • Approach: new device UDI data labels; similar to FDA model
  • Database: UDID
  • Data: 24 Attributes; similar to FDA (No BUDI)
  • Sub: TBD
  • Label: HRI & AIDC (1D or 2D), Direct Mark
  • STD: GS1, HIBBC, ICCBBA
  • Info: FDA Medical Devices

 

UK (MHRA)
  • 2021 Jan 01 – Brexit effective, Guidance released
  • 2021 Jan 01 – UK-mfg Class I, Custom, IVD register
  • 2021 May 01 – III, II Implantable, Active Implantable, IVD A register
  • 2021 Sep 01 – IIB other, IIa, IVD B, IVD Self-test register
  • 2022 Jan 01 – OUK-mfg Class I, Custom, IVD register
  • 2023 Jul 01 – CE replaced by UKCA mark; Legislation expected to require UDI

 

  • Approach: UK regulatory framework revamped due to Brexit; Mfrs and Devices must be registered in MHRA; GB will NOT comply with EU MDR/IVDR (Northern Ireland will); UDI voluntary field – future UDI legislation will require UDI.
  • UDI Data: ~70 attributes similar to EU reported to DORS (Device Online Reg. System) includes BUDI-DI
  • Data Sub: Website manual entry or XLS upload (1,000 max records); perhaps future machine-to-machine
  • STD: GS1/HIBCC/ICCBBA/IFA; GMDN, UKCA
  • Info: MHRA Medical Devices (Medicines and Healthcare Products Regulatory Agency)
United States (FDA)
  • 2014 Sep – Class III Devices
  • 2015 Sep – I/LS/LS Devices
  • 2016 Sep – Class II Devices
  • 2020 Sep – Class I Devices, enforced 2022 Sep

Approach: Report UDI Data & apply UDI to Labels by class
UDI Data: 57 attributes to GUDID
Data Sub: Website entry or electronic SPL (via ESG)
UDI Label: HRI & AIDC; Direct Mark
STD: GS1/HIBCC/ICCBBA; DUNS; GMDN/FDA

 

What is UDI?

UDI is a globally unique numeric or alphanumeric code that consists of two parts

Unique Device Identification, or UDI is a regulatory requirement first enacted by the US FDA, and now adapted by regulatory agencies around the world. UDI enhances patient safety by identifying each product with a static device identifier denoting the device labeler and the specific model or version of a device and the dynamic product identifier which identifies the expiration date, serial number, manufactured date or the lot/batch number of the device. While the UDI is created through the guidelines of an approved issuing agency, the medical device manufacturer is responsible for performing a submission of the identifier along with several product data attributes. If all of this sounds confusing, Reed Tech is here to help.

Learn more about approaches to managing UDI product data

SingleSource™ for Medical Devices

SingleSource™ for Medical Devices was built to meet the product data management needs of Medical Device manufacturers. See what it can do for you. Sign up for a demo today.

“Excellent customer and technical support. Reed Tech is a true partner – an extension of our internal resources. Their software solutions are enabling us to successfully meet UDI compliance dates in the US and UK.”

– Regulatory Director at a premier provider of infection prevention and other procedural products and services

Health Authorities and UDI Requirements

US FDA GUDID

UDI in the U.S. FDA GUDID

Class I devices and devices that have not been classified into Class I,  II or  III  must submit product data to the FDA’s GUDID by September 24, 2022

EU UDI submissions at Reed Tech

UDI in the European Union

Learn more about the data attributes, regulatory, legislation, and distinct differences between FDA GUDID and EU EUDAMED

China UDI submissions at Reed Tech

Health Authorities in Asia

Resources for understanding Unique Device Identification (UDI) regulatory requirements in Asia including China and South Korea

How to Utilize an Authorized Representative in UDI Submissions to Health Regulators

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