UDI – ONE Solution, ALL countries compliance


Global Specific UDI Requirements by Countries

  • 2022 Jun – ASUDID sandpit (beta) — general use, testing
  • 2023 Jan – Regulations and Guidance — in effect
  • 2023 Jan – Voluntary Compliance (high risk Class II, III, AIMD)
  • 2024 Jul – Mandatory Compliance (implants) — UDI labeling, UDI data
  • 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: Medical Device & IVD
  • 2020 Jun – UDI Barcode inserts required in a few implant product packages; UDI data 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,ICCBBA
  • Info: ANVISA (National Health Surveillance Agency)
  • 2022 – Proposal Health Canada UDI
  • Approach: Ongoing UDI preparation, expected to follow IMDRF UDI recommendations
  • 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 Jun 01 – Batch 2 (Remaining Class III)
  • 2024 Jun 01 Class II
  • 2026 – Class I and Remaining Devices
  • Sub: Website upload or Batch import
  • STD: GS1, ZIIOT and AHM.
  • 2020 Dec 01 — Actor Voluntary Economic Operator Registration
  • Currently EUDAMED is voluntary, and its mandatory use date has been postponed multiple times.
  • Placing UDI-carriers on the labels of Medical devices
    • 26 May 2021 - Implantable and class III devices
    • 26 May 2023 — Class IIa and class IIb devices
    • 26 May 2025 — Class I devices
  • Direct marking of the reusable devices
    • 26 May 2023 — Implantable and class III devices
    • 26 May 2025 — Class IIa and class IIb devices
    • 26 May 2027 — Class I devices
  • Placing UDI-carriers on the labels of IVDs
    • 26 May 2023 — Class D IVDs
    • 26 May 2025 — Class C and B IVDs
    • 26 May 2027 — Class A IVDs
  • Extended transition for legacy devices
    • 31 Dec 2027 — class III and class IIb implantable devices (except certain devices for which the MDR provides exemptions)
    • 31 Dec 2028 — Other class IIb devices and class IIa, class Im and class Is devices.
  • 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 Commission)
  • 2008 Mar – Guideline for Barcode Labeling
  • 2019 Dec 04 – PMD Act required barcode labels 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)
  • 2019 Apr 08 – UDI Draft Requirements released
  • 2019/2020 – UDI Pilot
  • 2020 Sep 06 – UDI Formal Requirements (v.3) released
  • 2023 Sep 01 – Class B, C, D devices (was 2022 Sept)
  • 2024 Sep 01 – Class A
  • Database: SAUDI — DI (Ramz)
  • Sub: Website upload or Bulk Upload (TBD)
  • STD: GS1/HIBCC/ICCBBA
  • 2022 High-risk implantables (3) All Coronary stents, orthopedic joint replacement implants, and intraocular lens
  • 2024 Class D (High-risk)
  • 2026 Class C (Medium-risk)
  • 2028 Class B (remaining)
  • Voluntary Class A (low-risk)
  • Database: Singapore Medical Device Register (SMDR) for class B or higher medical devices and the Class A
  • medical device database for Class A medical device. For all risk classes through MEDICS

  • Data Sub: Website XLS upload
  • UDI Label: HRI & AIDC; Direct Mark
  • STD: GS1, HIBBC, ICCBBA
  • 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: 40 data attributes 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/HIBCC/ICCBBA
  • Info: MFDS, IMDIS UDI System
  • Events:
    • 2015 -Oct: Administrative Guidance
    • 2020 – Nov: UDI Announcement
  • Compliance Timing
    • Class III implantables: 1 June 2021
    • Class III non-implantables: 1 June 2022
    • Class II devices: 1 June 2023
  • Description
  • Approach: new device UDI data labels; similar to FDA model
  • Database: Taiwan UDID (TUDID)
  • Data: 24 Attributes; similar to FDA (No BUDI)
  • Sub: Website upload (Web input) or batch upload
  • Label: HRI & AIDC (1D or 2D), Direct Mark
  • STD: GS1, HIBBC, ICCBBA
  • Info: FDA Medical Devices
  • 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 Jun 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)
  • 2014 Sep – Class III Devices
    • Required to bear UDI on the Device
    • Contain Standard date format
    • Provide UDI on stand-alone software device
    • UDI must be submitted to the GUDID database
  • 2016 Sep – Class III Devices
    • UDI as a permanent marking on the device that are intended to be used more than once and reprocessed before each use
    • The FDA does not intend to enforce UDI direct mark requirements for Non-Sterile Class III devices that are manufactured and labeled prior to September 24, 2016, when the device's UDI can be derived from other information directly marked on the device
  • 2016 Sep – Class II Devices
    • Required to bear UDI on the Device
    • Contain Standard date format
    • Provide UDI on stand-alone software device
    • UDI must be submitted to the GUDID database
  • 2018 - Sep – Class II Devices
    • UDI as a permanent marking on the device that are intended to be used more than once and reprocessed before each use.
    • The FDA does not intend to enforce UDI direct mark requirements for Non-Sterile Class II devices, other than LS/LS devices that are manufactured and labeled prior to September 24, 2018, when the device's UDI can be derived from other information directly marked on the device
  • 2022 Sep - Class I and unclassified devices, other than I/LS/LS devices
    • Required to bear a UDI
    • Contain Standard date format
    • Provide UDI on stand-alone software device
    • UDI as a permanent marking on the device that are intended to be used more than once and reprocessed before each use.
    • Directly marked with a UDI
    • The FDA does not intend to enforce UDI direct mark requirements for Non-Sterile Class I devices and unclassified devices, including Class I and unclassified device constituents of a co-packaged combination product or kit other than LS/LS devices that are manufactured and labeled prior to September 24, 2022, when the device's UDI can be derived from other information directly marked on the device
  • 2022 Dec - Class I and unclassified devices, other than I/LS/LS devices
    • UDI must be submitted to the GUDID database.
  • Class I CGMP-exempt devices are excepted from UDI requirements.
  • Approach: Report UDI Data & apply UDI to Labels by class
  • UDI Data: 57 attributes to GUDID
  • Data Sub: Website entry or electronic HL7 SPL (via ESG)
  • UDI Label: HRI & AIDC; Direct Mark
  • STD: GS1/HIBCC/ICCBBA; DUNS; GMDN/FDA

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