Unique Device Identification (UDI) Solutions - Clinical, Regulatory & Automation solutions for Life Sciences

Unique Device Identification (UDI) is a key global harmonization process for more reliable data that aids overall medical device traceability throughout the device supply chain. Health Authorities rolled out medical device UDI requirements, such as GUDID by US FDA, EUDAMED by European Union under new MDR/IVDR, NMPA UDI by China, and many more.

Global device manufacturers must often submit UDI data to a myriad of country-specific regulatory authorities, each with their unique data exchange standards and requirements. Our UDI solutions enable device manufacturers to implement a single data syndication system for global coverage. Leveraging one solution to aggregate, validate and submit product data to regulatory agencies at the market-specific level around the globe.

Functionality

Validation

Deliver trusted, high-quality product data by leveraging our standard data quality and data validation tools.

Ensure that product data is accurate and compliant with any pre-defined set of validation rules from regulatory agencies, as well as any internal, user-configured data attributes and validation rules.

Electronic Submissions / Gateway

Proven electronic submission capabilities for regulatory data submissions that ensure data accuracy and a scalable process for data compliance in all markets.

Ease of enabling new countries at a fraction of the cost of alternatives such as data submission services or standalone country-level compliance solutions

UDI Partner Interfaces

Pre-configured connectors to all major GDSN-compliant data pools including 1WorldSync, GHX, NPC, and Syndigo that enable global data synchronization with recipient-specific product attributes

Out-of-the-box connectors to UDI databases across the globe including FDA’s GUDID, Europe’s EUDAMED and China’s UDID

Data Pooling & Mapping

‘Drag & drop’ functionality helps data analysts map, extract and collate master data to any target data recipient, be it a system or a process.

All major file & message formats are supported ‘out-of-the-box’. Data collation can be automated using scheduled jobs, or custom interfaces or real-time web services APIs

System Integration

Easily integrate to RIM, PLM, ERP and other systems to source the relevant master data using configurable message/file formats.

Supports AS2 gateways and AS4 Access Points for message delivery using all required XML formats including the GS1 XML for GDSN, HL7 SPL for GUDID, and SOAP XML for EUDAMED.

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)
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 dat reported to RNI by healthcare provider
2021 Feb – UDI System Publication
2023 – Class IV (highest-risk) devices
2024 – Class III (high-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
Jun 01 – Batch 2 (Remaining Class III)
TBD – Class II
TBD – Class I and Remaining Devices

2020 Dec 01 —Actor Voluntary Economic Operator Registration
2021 May 26 – Medical Devices DoA for MDR, Class I Self-Certification
2021 Oct 4 – 2023 end – UDI/Device Voluntary Registration
May 26 – IVD Devices DoA
2024 mid – EUDAMED fully functional notice
2024 end to 2026 mid: Mandatory Registration period or upon Serious Incident / EUDAMED Production begins
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 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)

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

2022 High-risk implantables (3)
2024 Class D (High-risk)
2026 Class C (Medium-risk)
2028 Class B (remaining)
Voluntary Class A (low-risk)

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
Info: MFDS, IMDIS UDI System

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

DDi can put you on the fast track to Device Unique Device Identification (UDI) Solutions