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.

GLOBAL UDI REQUIREMENTS

UDI Global Placeholder
UDI Global

Global UDI Summary

Below is a high-level summary of UDI related activities around the world. 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.

Australia
  • 2019 Jan – Draft guidance released
  • 2019 Aug – Draft guidance comments published
  • 2021 May? – UDI labels follow EU dates (TBC)
  • TBD – Phased UDI data reporting

 

  • Approach: similar to EU regulation; Data reported to AusUDID in phases (EU+1 year?); Label compliance dates to follow EU?
  • UDI Data: attributes (close to EU) to AusUDID
  • UDI Label: HRI & AIDC; Direct Mark
  • STD: GS1/HIBCC/ICCBBA
Brazil
  • 2018 Jun – UDI regulation published
  • 2020 Jun – UDI required on identified product labels
  • 2020 Jun – UDI data reported to RNI (by healthcare provider)

 

  • Approach: Start with 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

Canada

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

China (NMPA)
  • 2019 2H – UDI Pilot, Rules, database tests
  • 2020 Mar-Jun – Connectivity and applications tests
  • 2020 Oct — UDI data & label req’d for Group 1
  • 2022 October – Remaining Class III
  • 2024 October – Class II
  • 2026 October – Remaining
European Union (EC)
  • 2020 Dec — EUDAMED Pre-Production, Voluntary
    Economic Operator Registration
  • 2021 May – Medical Devices DoA, Class I Self-cert.
  • 2022 May – EUDAMED Launch (new date)
  • 2022 May – IVD Devices DoA
  • 2023 Nov – Legacy, MD, IVD Registration Deadline

 

  • Approach: Register device, report UDI data & apply UDI to labels per Legacy, MDR, IVDR rules and timing
  • UDI Data: 102+ 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 + y)
  • STD: GS1/HIBCC/ICCBBA/IFA; SRN; CND

 

Japan

NA

Approach: UDI already in place for Device Labels

 

Netherlands
  • 2018 July – Mfr apply UDI on label of Inclusion List products
  • 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”

  • Approach: Start with devices on “Inclusion List” UDI Data: 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
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)
Saudi Arabia
  • 2021 Aug Class D (High Risk)
  • 2022 Feb Class B & C (Medium Risk)
  • 2023 Feb Class A (Low Risk)
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
  • 2019 Jun – Class IV Devices UDI Labeling start
  • 2019 Oct – Class IV Devices UDI Labeling req’d, UDI Data start
  • 2020 Jul – Class III Devices
  • 2021 Jul – Class II Devices (TBC)
  • 2022 Jul – Class I Devices (TBC)

 

  • Approach: 2H 2019 Pilot; UDI Label followed by UDI Data Report
  • UDI Data: N attributes to database
  • Data Sub: XLS upload/website edit, testing electronic API retrieval (& upload?)
  • UDI Label: HRI & AIDC?
  • STD: GS1
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

 

United States
  • 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

 

UK

NA

  • Approach: UK UDI repository prompted by the scheduled end of the Brexit transition on 31 Dec 2020

What is UDI?

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

Evolution of UDI: A Look Back at RAPS 2020 Euro Convergence

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