UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates. This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines. This presentation originally aired during the 2021 State of Medical Device Virtual Summit.

1. 2020-Dec-09
Implementing a Global
Unique Device Identification
(UDI) Solution:
Regional Update and
Requirements

2. MEDICAL DEVICE QUALITY IS ALL WE DO,
AND WE’RE ALWAYS AHEAD OF THE GAME.
© Copyright 2020 by Greenlight Guru 2
© 2020 Reed Tech

3. About Reed Tech
© 2020 Reed Tech 3
Providing best-in-class information-based solutions and services to meet the needs of the life
sciences industry, government agencies, and the intellectual property market.
• Founded 1961; over 1,000 employees
• Part of LexisNexis and RELX Group;
offices in Horsham, PA USA; Alexandria, VA USA;
Leiden, The Netherlands
• Sole contractor to U.S. Patent Office since 1970
providing patent processing, composition, and databases
• Provider of regulatory product data management and submission
solutions to over 1,000 Medical Device and Pharmaceutical clients
Mfr
Customers,
Trading Partners
Health
Authorities
GS1
Solution
Partner
ISO Certified
since 1998
(9001:2015)
HL7
Member
since 2005
MedTech
Europe
Member
1 World
Sync
Partner
The Vision
Council
Consultant

4. Discussion Topics
© 2020 Reed Tech 4
Lessons to Guide Your Global UDI Approach
Global UDI Timeline
Regional UDI Updates
Questions and Answers

5. Lessons to Guide Your
Global UDI Approach
© 2020 Reed Tech 5

6. Medical Device Global Launch!
© 2020 Reed Tech 6
 Medical Device Concept
 Research/Design
 Development
 Testing
 Verification/Validation
 Regulatory Approval
 UDI
 Global Launch?
US EU
S Korea
Brazil
Australia Singapore
China
Saudi Arabia
Taiwan
India
Turkey

7. Global UDI Landscape, Trends, & Challenges
More UDI Technical Challenges
• Minimal Global Harmonization:
‐ Dissimilar & Unclear Policies
‐ Incomplete & Changing Specs
‐ Different Datasets & Business Rules
‐ Custom Submission Methods
• Changing Deadlines with Short Notice
• Keeping Knowledge Current
• Disparate Source Data Repositories
• Questionable Source Data Quality
• New Data Mgmt Compliance Reqm'ts
More UDI Regulatory Reqm'ts
• US FDA UDI
• EU MDR/IVDR UDI
• China, South Korea,
Saudi Arabia, other …
© 2020 Reed Tech 7
More UDI Customer Reqm'ts
• NHS England eProcurement
• GPOs and Retailers GDSN
• Healthcare Providers GDSN
• Track & Trace
• Safety Registries
• Payers/Insurance
NHS
England
$

8. Global UDI Data Mgmt 6 Goals
© 2020 Reed Tech 8
Trusted, uniform source of global
master UDI data with a governance
policy to ensure high quality
1. Global Master Data Source
Consolidated platform for regulator
and commercial trading partner data
(avoid multiple silos)
2. Single, Central Repository
System expansion for future data
channels; scalability for volume;
flexibility for new processing reqm’ts
3. Incremental Functionality
Save cost, time, resources with
interfaces to existing systems;
automate bulk electronic processing;
preferred SaaS solution, etc.
4. Cost-effective Solution
Meet global regulators’ UDI
reqm’ts to maintain market access
5. Regulatory Compliance
Meet customers’ specs for product
UDI information (electronic catalogs)
6. Commercial Support

9. UDI Implementation Summary
A. Collect and Create Source UDI Data
B. Normalize and Validate Source UDI Data
2. Data Prep
A. Create UDI Governance Team
B. Identify UDI Requirements for Your Products
C. Evaluate Your Situation
D. Prepare UDI Environment
1. UDI Process
Prep
A. Start UDI Production and Maintain Data & Systems
B. Prepare for Other Regional UDI Requirements
5. UDI
Operation
A. Prepare Labeling Environment
B. Test Labels
4. Labeling
System
A. Evaluate, Select, and Implement UDI Solution
B. Create Gateway and Regulatory Accounts
C. Submit UDI Data
D. Verify UDI Submission and Publication
3. UDI Data
System &
Submission
© 2020 Reed Tech 9

10. UDI Data Mgmt/Submission Models
Manufacturer
Web Interface
Manual
Entry
Hosted Software
(SaaS)
Build
Buy
Rent
Device
Database
My Sample Title
Health
Authority
DATA
DATA
DATA
© 2020 Reed Tech 10

11. UDI Data Mgmt Approach Criteria
Characteristics A B C
Provider – Knowledgeable, Experienced, Thought Leader, Core Expertise
System – Practical Processing of Low/Medium/High Volumes
Robust & Current Data Validation, Controlled Vocabularies
Data Management (roles, navigation, ease of use)
Submission Account and Testing
Submission ACK Processing and Reporting
Compliance 21CFR Part11 (req'd for FDA SPL), EU Annex 11
Implementation – Startup Time/Effort
Impact/Connectivity to Existing Systems
Future Proof – Scalable for Additional Records
Flexible for Additional Data Channels
Support – SME Knowledge, Access, Timing
Cost Effective – Electronic Bulk Automated Processing, Cost/Value
© 2020 Reed Tech 11

12. Global UDI Data Mgmt Best Practices
1. Data Governance
• Update policy, SOPs, documentation, training, etc.
• Assign roles and permissions based on job function and region
• Control data attributes through change management workflow
2. Master Data Attributes
• Establish a single, reliable source of truth
• Remove obsolete versions and products; remove duplicate part numbers
• Manage/synch product attributes for regions, regulators, and business partners
3. Maintenance/Monitoring
• Update data and systems promptly
• Monitor and alert compliance requirement changes and deadlines
• Keep knowledge base current and plan for future!
© 2020 Reed Tech 12

13. Global UDI Data Mgmt Best Practices(cont’d)
4. Use UDI Product Data
• Spread UDI awareness throughout organization
• Ensure accurate and consistent data is distributed to regulators and business partners
• Standardize catalog information to your customers and downstream systems
• Use Product Ids for manufacturing, ordering, delivery, returns, adverse event
reporting, recalls, etc.
© 2020 Reed Tech 13

14. Global UDI Timing
Implementation Summary
© 2020 Reed Tech 14

15. Past UDI Data Reporting Reqm'ts
2014 2015 2019
2016 2017 2018
2017 Sep
NHS*
England
Class III
2018 Sep
NHS*
England
Class
IIa/b
2014 Sep
US FDA
Class III
2015 Sep
US FDA
I/LS/LS
2016 Sep
US FDA
Class II
2019 Oct
S. Korea
Class IV
2019 Sep
NHS*
England
Class I
I/LS/LS = Implantable, Life Supporting, Life Sustaining
LIR = Dutch National Implant Registry
2020
2020 Jan
Neth.*
Implants
(LIR)
2020 Jul
S. Korea
Class III
© 2020 Reed Tech 15
2020 Dec
EU
Eudamed
Actor
2020?
UAE
Dubai HA
* GDSN required to report product data

16. Upcoming UDI Data Reporting Reqm'ts
© 2020 Reed Tech 16
* GDSN required to report product data
2021 2022
2022 Sep
US FDA
GUDID
Class I
2021 Sep
NHS*
England
A,B,C,D
IVD
2021 May
EU
MDR DoA,
EUDAMED
Vol. UDI, NB
2022 May
EU
IVDR DoA,
EUDAMED
MD+IVD
2022 Jul
S Korea
Class I
2021 Jul
S Korea
Class II
2021 Jan
China
Batch 1
2022?
India
TBD
Canada
TBD
Australia
TBD
UK
2022 Oct
China
Class III
2021 Aug
Saudi
Arabia
Class D
2022 Feb
Saudi
Arabia
Class B,C
2022
Singapore
Phase 1
2021 Jun
Taiwan
C.III Imp

17. Regional Health Authorities
UDI Implementation Notes
© 2020 Reed Tech 17

18. U.S. – FDA
© 2020 Reed Tech 18
2013-Sep-26 Final Rule published
2020-Jun-30 Class I dates extended to 2022
Events
2014-Sep-26 Class III Devices
2015-Sep-26 I/LS/LS Devices
2016-Sep-26 Class II Devices
2022-Sep-26 Class I Devices
• Approach: UDI data reported & on labels by
class; no change to device approval/registration
• Database: GUDID; functional; 2.7M records in
public AccessGUDID
• Data: 57 reported attributes
• Sub: website entry or M2M SPL file via ESG
• Label: HRI & AIDC; Direct Mark
• STD: GS1/HIBCC/ICCBBA; DUNS; GMDN/FDA
• Info: FDA UDI
Compliance Timing
Description
FDA – Food and Drug Administration

19. EU – EC
© 2020 Reed Tech 19
2021-May-26 Medical Devices DoA
2022-May-26 IVD Devices DoA;
EUDAMED Launch Notice
(6 modules fully functional)
Events
2020-Dec-01 EUDAMED vol Actor module
2021-May-26 EUDAMED vol UDI/Device &
Cert/NB modules; Class I self-cert req’d
2022-Nov-26 Legacy, MD, IVD: UDI/Device
Registration Mandate (+6m)
2024-May-26 Legacy, MD, IVD: UDI/Device
Registration Deadline (+18m)
Compliance Timing
• Approach: new regulations for review, approval,
reg, UDI data/labels, vigilance, etc.; rules &
timing for Legacy Directive, MDR, IVDR devices
• Database: EUDAMED 6 modules; Actor (open),
UDI & Cert (2021-05); Vigilance, CI, Surveillance
• Data: 112+ attributes; new BUDI-DI “device
group” concept
• Sub: website entry/XML upload or M2M XML
transfer via Data Exchange (DTX)
• Label: HRI & AIDC by class (2021,2023,2025)
Direct Mark by class (Label + 2y)
• STD: GS1/HIBCC/ICCBBA/IFA; SRN; EMDN (CND)
• Info: EC Reg, UDI
Description
EC – European Commission

20. China – NMPA
© 2020 Reed Tech 20
2019-Jul-03 UDI Batch 1 pilot notice & guide
2020-Aug-10 UDID launch for Batch 1
2020-Sep-30 Batch 1 notice: 2020-Oct-01
deadline now 2021-Jan-01;
69 (64+5) categories
Events
2021-Jan-01 Batch 1 UDI data & label req’d
2022-Oct-01? Remaining Class III
2024-Oct-01? Class II
2026-Oct-01? Class I and Remaining
• Approach: new device UDI data/labels; start
with “Batch 1” class III devices, then by class
• Database: UDID; enhanced @2020-Sep;
functional with 150,000+ items @2020-Nov
• Data: 61 attributes; 37 similar to US (no BUDI)
• Sub: website entry/file upload or M2M XML
transfer via API
• Label: HRI & AIDC (1D or 2D barcode)
• STD: Issuing Agencies: GS1 China, ZIIOT*,
Ali Health Mashangfangxin Platform
• Info: NMPA
Description
* Zhongguancun Industry & Information Research
Institute of Two-Dimensional Code Technology
Compliance Timing
NMPA – National Medical Products Administration

21. South Korea – MFDS
© 2020 Reed Tech 21
2016-Dec Medical Device Act revised (UDI)
2019-Jun UDI System introduction
Events
Date UDI Trace & Trace
2019-Jul/Oct Class IV ~~~
2020-Jul Class III Class IV*
2021-Jul Class II Class III
2022-Jul Class I Class II
2023-Jul ~~~ Class I
• Approach: new device UDI data/labels by class;
AND Supply Reporting (T&T) of ~10 production
fields each month
• Database: UDI System (no Pre-production)
• Data: 40 attributes; 15 auto populated by MFDS
in initial XLS download; 15 similar to US (no BUDI)
• Sub: website XLS download/complete data
/upload file or M2M XML transfer via API
• Label: HRI & AIDC, Direct Mark
• STD: GS1, HIBCC, ICCBBA
• Info: MFDS
Description
MFDS – Ministry of Food and Drug Safety
Compliance Timing
* Enforcement discretion to EOY 2020

22. Saudi Arabia – SFDA
© 2020 Reed Tech 22
2019-2020 UDI Pilot
2020-Sep-06 Formal Guidance (V3) released
2020-Oct-01 UDI Database launched
Events
• Approach: new device UDI data/labels by class;
(Import and Track & Trace modules on hold)
• Database: SAUDI-D; functional
• Data: 43 attributes; 29 similar to US (no BUDI)
• Sub: website manual entry only: expect future
XLS upload and M2M XML file transfer
• Label: HRI & AIDC, Direct Mark
• STD: GS1, HIBCC, ICCBBA
• Info: SFDA
Description
SFDA – Saudi Food and Drug Authority
Compliance Timing
2021-Aug-01 Class D (high risk)
2022-Feb-01 Class B & C (medium risk)
2023-Feb-01 Class A (low risk)

23. Taiwan – FDA
© 2020 Reed Tech 23
2015-10-30 Administrative Guidance
2020-Nov-05 UDI Announcement
Events
• 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
Description
FDA – Food and Drug Administration
Compliance Timing
2021-June-01 Class III Implantables
2022-June-01 Class III others
2023-June-01 Class II

24. Singapore – HSA
© 2020 Reed Tech 24
2019-Oct-19 UDI Implementation
Notice, Presentation
Events
• Approach: new device UDI data/labels; first (3):
coronary stents, orthopaedic joint replacement
implants & Intraocular lens; then by class
• Database: Singapore Medical Device Register
(SMDR), existing DB with UDI modification
• Data: TBD
• Sub: TBD
• Label: HRI & AIDC; accept US FDA & EU EC label
• STD: GS1, HIBCC, ICCBBA
• Info: HSA Medical Devices
Description
HSA – Health Sciences Authority
Compliance Timing
2022 (3) Implantables (high risk)
2024 Class D (high risk)
2026 Class C (med risk)
2028 Class B (med risk)
Voluntary Class A (low risk)

25. Australia – TGA
© 2020 Reed Tech 25
2019-Jan Proposal for UDI System
2020-Sep-23 UDI Consultation Survey
Events
• Approach: new device UDI data/labels by class;
proposal follows EU model, but Survey
questions indicate perhaps reconsiderations
• Database: AusUDID proposed
• Data: ~25 high-level proposed attributes
includes BUDI-DI
• Sub: TBD (expect similar to EU)
• Label: HRI & AIDC (1D or 2D), Direct Mark (DM)
• STD: GS1, HIBCC, ICCBBA
• Info: TGA Medical Device & IVD
Description
TGA – Therapeutic Goods Administration
Compliance Timing
Draft Dates* MD UDI MD DM IVD UDI
2021-May-26 III ~~~ ~~~
2023-May-26 IIa/b III 4
2025-May-26 I II/b 3,2
2027-May-26 ~~~ I 1
(* expect dates to be rescheduled)

26. UAE – DHA
© 2020 Reed Tech 26
UDI Scope – Only for DHA, a regulator and
healthcare provider in the Emirate of Dubai
(1 of 7 emirates in United Arab Emirates).
Events
• Approach: new device UDI data/labels
• Database: GS1 UAE hosted data source
(BrandSync)
• Data: ~ two dozen attributes
• Sub: Manual entry, M2M?
• Label: HRI & AIDC
• STD: GS1
• Info: DHA, GS1 UAE
Description
DHA – Dubai Health Authority
Compliance Timing
2020 UDI Implementation
(to be confirmed)

27. UK – MHRA
© 2020 Reed Tech 27
2020-Jan-21 UK Parlm’t ratified EU withdraw
2020-Sep-01 Guidance docs:
MHRA Post-transition Period Information,
Regulating Medical Devices from 1 Jan 2021
2020-Dec-31 End of Brexit transition with EU
Events
• Approach: new device registration reqm’ts:
• Mfrs & Devices must be registered in MHRA
• Devices do not need to re-register in MHRA
• GB will NOT comply with EU MDR/IVDR
• Northern Ireland will comply EU MDR/IVDR
• No mention of device UDI data/labels
• Info: MHRA Medical Devices
Description
MHRA – Medicines and Healthcare
products Regulatory Agency
Compliance Timing
2020-Dec-31 EU ends recognition of UK NB
2021-Jan-01 GB allows voluntary use of
UKCA (UK Conformity Assessed) mark;
GB device labels need CE or UKCA mark
2021-May-01 Class III, IIb Implants, Active
Implants, IVD A registered
2021-Sep-01 Class IIb other, IIa, IVD B,
IVD Self-test registered
2022-Jan-01 Class I, Custom, IVD general reg.
2023-Jun-30 GB ends recognizing CE mark
and EU Certificates
2023-Jul-01 GB requires use of UKCA mark

28. Takeaways for Global UDI Data Mgmt
• Regulatory and commercial requirements are increasing globally
• Monitor your market regions and trading partners
• Maintain regulatory compliance and market competitiveness
• UDI specifications are complex, e.g., EU MDR
• Comprehensive subject matter expertise is necessary
• Ensure data governance, quality, integrity, security, maintenance
• Centralized master data mgm’t platform is critical
• Need scalability for new products, regions, acquisitions
• Need flexibility for new/changing demands (enhance/rework)
• Simplify and standardize processes and user interface
© 2020 Reed Tech 28

29. Reed Tech SingleSourceTM
For Medical Devices
© 2020 Reed Tech 29
SingleSource enables Medical Device manufacturers to quickly react and affordably
comply with business-critical product data submission requirements across the globe.
It provides a single, scalable, and flexible data management platform which allows
users to collect, maintain, validate, and submit their product data to global regulators
and supply chain partners.

30. For more information, contact:
Reed Tech Life Sciences Team
MedDevice@ReedTech.com
+1-215-557-3010
www.ReedTech.com/udi
30
© 2020 Reed Tech

31. Questions?
© 2020 Reed Tech 31