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 December 8, 2022
LexisNexis SingleSource Medical Device Unique Device Identification (UDI)
LexisNexis Life Sciences SingleSource™ for Medical DevicesMedical 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
LexisNexis Life Science Solutions is a leading FDA supplier of Unique Device Identification (UDI) information, submitting close to one-quarter of all NLM Access GUDID UDI records annually, representing about 34% of electronic SPL submissions to GUDID.
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. LexisNexis has active UDI channels for US FDA, China NMPA, South Korea MFDS and staging for EU EUDAMED and Australia UDID.
2026 Is a Global UDI Turning Point — Are You Ready?
Major UDI requirements are taking effect across the EU, Australia, and Switzerland. Ensure your compliance strategy is aligned before deadlines arrive.
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, LexisNexis 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.
- 2022-Jul-04 – AusUDID Sandpit (open)
- 2023-Apr-24 – AusUDID Pre-Prod (limited, test)
- 2024-Q2 – Vol Labeling/Data (@regs)
- 2025-Q2 – +1 Req’d Labeling/Data (MD III, IIb)
- 2026-Q2 – +2 Req’d Labeling/Data (MD IIa)
- 2027-Q2 – +3 Req’d Labeling/Data (MD Is, IVD 4,3,2)
- 2028-Q2 – +4 Req’d Labeling/Data (IVD 1instr/sfw)
- 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)
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
- TBD – Class I and Remaining Devices
- 2020-Dec-01 – Actor Vol Registration
- 2021-May-26 – MDR Class I Self-cert req’d
- 2021-Oct-04 – UDI/Device & Cert/NB Vol Reg
- 2022-May-26 – IVDR Class A Self-cert req’d
- 2027-Q4 – Legacy, MD, IVD: UDI/Device
Reg Mandate Start (notice+6m) - 2029-Q2 – Legacy, MD, IVD: UDI/Device
Registration Deadline (notice+24m)
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)
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)
- 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)
- 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)
- 2020-Oct-01 – UDI Database open (voluntary)
- 2021-Oct-26 – UDI Compliance Dates delayed
- 2022-Jun-24 – UDI Compliance Dates delayed
- 2023-Sep-01 – Class D (high risk)
- 2023-Sep-01 – Class B & C (medium risk)
- 2024-Sep-01 – Class A (low risk)
- 2022 High-risk implantables (3)
- 2024 Class D (High-risk)
- 2026 Class C (Medium-risk)
- 2028 Class B (remaining)
- Voluntary Class A (low-risk)
- 2019-Jul-01 Class IV*
- 2020-Jul-01 Class III
- 2021-Jul-01 Class II
- 2022-Jul-01 Class I
- 2023-Jul-01 ~~~
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: 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
- 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
- 2015 Sep – I/LS/LS Devices
- 2016 Sep – Class II Devices
- 2020 Sep – Class I Devices, enforced 2022 Dec (previously was 2022 Sept) See Final Guidance
• 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
Learn about regulations and requirements for global health authorities. Click here to access the ‘Understanding UDI’ series.
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, LexisNexis Life Sciences is here to help.
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“Excellent customer and technical support. LexisNexis Life Science 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