Unique Device Identification —aka UDI— is about more than barcodes and regulatory red tape. This global system for identifying medical devices is a chance to radically improve the quality of life for patients, providers, and producers of medical devices. However, implementing UDI into your product lifecycle means navigating differing requirements in both the United States and the European Union. If you’re looking to go global, we’ve brought together three industry leaders on the subject to make sure you know the difference. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.

1. Medical Devices
EU and Global Update
on Unique Device Identification
2022-Aug-30

2. Speakers
© 2022 Reed Tech 2
Sr. Manager Information Solutions
Reed Tech
Director of Product Development, Medical Devices
Reed Tech

3. About Reed Tech
© 2022 Reed Tech 3
Trusted Team Partner
455+ medical device customers since inception
Small (1 record) to large (250,000 records) customers
Flexible role assignments for in-country representatives and corporate users
Experienced, Major Industry Provider
~34% of all FDA GUDID SPL records
Support US, EU, China, Korea; Roadmap for international UDIDs
Industry Experts
18+ years of SPL knowledge (SPL-UDI since 2014); up-to-date SME knowledge
from guidance, pilots, and trade groups (MedTech Europe committees, etc.)
Preparation, Submission, and Lifecycle Data Management of
Medical Device UDI product information
Proven, Current, Compliant Systems (21 Part 11, Annex 11, Audit Trail)
750,000+ SPLs submitted to FDA GUDID; 5,000+ records to EU EUDAMED;
Direct M2M (AS2/4, APIs) connections to HAs for auto, bulk submissions
GS1 Solution
Partner
HL7 Member
since 2005
1World Sync
Alliance
The Vision Council Consultant
MedTech Europe Member
ISO 9001
Quality
ISO 27001
Security
DTA Consultant

4. Global UDI Landscape
Multiple Regional Requirements
© 2022 Reed Tech 4

5. Regulators Are Adopting UDI
Active
• U.S. (2014)
• EU (2021/2022)
• South Korea (2019)
• Netherlands (2020)
• UAE (2020)
• China (2021)
• Taiwan (2021)
• Saudi Arabia (2023)
Pending
• Australia
• Brazil
• Canada
• India
• Japan Numerous Regulators have or will in the near
future require product information in UDI standards
© 2022 Reed Tech 5
UDI
UDI
UDI
UDI
UDI UDI
UDI
UDI
UDI
UDI
UDI
UDI
UDI
UDI
• Malaysia
• Singapore
• Turkey
• UK
• Other
UDI

6. Past UDI Data Reporting Reqm'ts
© 2022 Reed Tech 6
Turkey – TMMDA
Japan – PMDA
US – FDA
EU – EC
Netherlands – LIR
South Korea – MFDS
UAE – Dubai HA
Brazil – ANVISA
UK – NHS England
2017
2015 2018 2020
2014 2016
Sep-III Sep-I/LS/LS Sep-II
Sep-III
2019
Sep-I
Jul-III
2020-All? Devices
Jan-Incl. List
Oct-IV
Dec-EUD Actor (vol)
Jun-Implants UDI Pkg Insert
2008-Device reg & barcode label (recommended)
Sep-IIa/b
2004-Device reg & barcode label
 UDI Submission Deadline,  Milestone

7. US – FDA
EU – EC
China – NMPA
Singapore – HSA
South Korea – MFDS
Taiwan – FDA
UK – MHRA
UK – NHS England
2022
India – CDSCO
May-IVDR DoA
May-MDR DOA
Jun-III Implants
Jul-II Jul-I
Jun-Batch 2 (other IIIs)
Sep-IVD A,B,C,D
2022-(3) Implants
Jun-III Others
Jan-I, IVD-General (device reg)
Oct-EUD UDI (vol)
Sep-I (Label)
Jan-Batch 1
Sep-IIb other, IIa, IVD-B, IVD-Self Test (device reg)
May-III, IIb Imp, Active Imp, IVD-A (device reg)
Jan-UDI labels
2021
Dec-I (GUDID)
Current UDI Data Reporting Reqm'ts
© 2022 Reed Tech 7
 UDI Submission Deadline,  Milestone

8. Australia – TGA
Canada (2021 UDI Proposal) Egypt (2021 UDI Guidance) Ecuador
Japan Turkey India
EU – EC
Saudi Arabia – SFDA
Singapore – HSA
Taiwan – FDA
UK – MHRA
2023 2025
Brazil – ANVISA
China – NMPA
2026+
2024
Sep-B,C,D
2024-D
Jun-II
TBD-III, II, I
2026-C 2028-B
Jun-GB stops recognizing CE mark & EU certs; Requires UKCA mark; (Require UDI?)
TBD-UDI Reg.
TBD-UDI Database
Sep-IV (?) Sep-III (?) Sep-II (?) 2027 Sep-I (?)
TBD-II, I NMPA/Prov.
Q2-EUD Notice 2024-Q4 to 2026-Q2 EUD UDI (18m man. reg)
(UDI vol reg)
Jan-Vol III, II, AIMD Jul-Reqd Implants
Sep-A
Future UDI Data Reporting Reqm'ts
© 2022 Reed Tech 8
 UDI Submission Deadline,  Milestone

9. UDI Implementation Challenges
© 2022 Reed Tech 9
• Dissimilar, unclear policies
• Incomplete, changing data specs
• Different reporting datasets
• Varied submission protocols
• Changing deadlines
• Need UDI SME for each region
• Global HAs: US, EU,
China, S Korea,
Saudi Arabia,
Australia, UK …
• Customers: GPOs,
retailers, healthcare
providers (GDSN)
• Diverse data owners, storage
locations, and formats
• Questionable data quality
• Compliance standards,
21 CFR Part 11, Annex 11 …
• Managing many product records
• Managing many regional domains
Health Authority Regulations Internal Data Management More Stakeholders
“Full” Global UDI Harmonization is Not Materializing
Regional UDIDs contain some common core information, but also include
varying regional content, i.e., “Convergence, not full Harmonization”


10. EU MDR / IVDR Overview
Summary
© 2022 Reed Tech 10

11. What is Different About the EU UDI?
© 2022 Reed Tech 11
• New Regulatory Framework
• MDR/IVDR replace Directives
• All NBs new designation (no grandfathering)
• All Products new certification (no grandfathering)
• UDI policy is similar, but different than US
• New Concepts
• Directive, Legacy, Equivalent, MDR/IVDR compliant devices
• Basic UDI-DI (group) and UDI-DI (device) identifiers, (and Master DI)
• More UDI Data, SRN, EMDN, etc.
• Confusing Timing
• Place on market, registration, UDI labels, UDI Direct Marking all scheduled differently
• EUDAMED – Actor and UDI Device modules open now for voluntary registration
• 2024-Q4 to 2026-Q2 Mandatory UDI/Device Registration

12. EU EUDAMED
© 2022 Reed Tech 12
NB
MF
EC
IM
AR CA
PR
EUDAMED
(6 Modules)
Note: Only primary associations are shown; AR - Authorized Representative, CA - Competent Authority, EC - European Commission,
IM - Importer, MF - Manufacturer, NB - Notified Body, PR – (S/PPP) System/Procedure Pack Producer, SP - Sponsor
All MF
Public
EC CA
SP
Economic
Operators
(Actors)
UDI/
Devices
Certificates
& Notified Bodies
Clinical
Investigations
& Perf Studies
Vigilance
& Post-Mkt
Surveillance
Market
Surveillance

13. EUDAMED Timeline
© 2022 Reed Tech 13
Actor Module 2020-Dec-01 Voluntary Production Registration
UDI/Device Reg & Cert/NB 2021-Oct-04 Vol Prod Reg
2024-Q4 EUDAMED Mandatory Production Begins
Delay
6m
2024-Q4 Mandatory Production Registration
2024-Q4 Transition*
2024-Q4 Mandatory Production
Vigilance, Clin Invest, & Mkt Surv 2022-Apr Playgrd - limited Open
*18m Mandatory Production Registration Period
or upon Serious Incident Report (2, 10, 15 days)
2026-Q2 Mandatory Prod Reg
Audit
~6m 2024-Q2 EC Notice (EUDAMED fully functional)
2021 2022 2023 2024 2025 2026 2027
2020
2021-May-26: MDR
Date of Application
2022-May-26: IVDR
Date of Application

14. EUDAMED Timing (Quick Reference Chart)
© 2022 Reed Tech 14
EUDAMED
Module
Playground
(voluntary)
Production
(voluntary)
Production
(mandatory)
Actor
2019-Q1
Launch (1)
2020-Dec-01 2024-Q4
UDI/Device 2019-Q2
Launch (1)
2021-Oct-04
2024-Q4 to 2026-Q2
Start 18m Deadline
Transition
Certification/NB
Vigilance
2022-Apr 2024-Q2
Launch (1) Open (2)
TBD 2024-Q4
Clinical Investigation TBD 2024-Q2
Launch (1) Open (2)
Market Surveillance
Note: (1) Limited accounts & functionality, (2) Public access & full functionality 3) EC “Fully Functional” Notice 2024-Q2
ü
ü
ü
ü
ü

15. MDR / IVDR – 3 Categories of Devices
© 2022 Reed Tech 15
Directive Devices
MDD/AIMDD/IVDD devices discontinued as of DoA
Legacy Devices
Directive devices continued to be placed on market
MDR/IVDR Devices
Regulation compliant devices placed on market
MDD - Medical Devices Directive 93/42/EEC; AIMDD - Active Implantable Medical Device Directive 90/385/EEC;
IVDD - In Vitro Diagnostic Directive 98/79/EC; MDR - Medical Devices Regulation 2017/745; IVDR - In Vitro Diagnostics Regulation 2017/746

16. 2021 2022 2023 2024 2025 2026 2027 2028
2020
2022-May-26
IVDR DoA
2021-May-26
MDR DoA
18m Reg Period
or upon Serious Incident
2024-Q4...2026-Q2
Mandatory Reg.
2021-Oct-04 to 2024-Q4
Voluntary Registration
2024-Q4 EUDAMED Production (mandatory)
2024-Q2 EUDAMED Notice (+6m delay)
EU MDR/IVDR Timeline
© 2022 Reed Tech 16
Place on Mkt Legacy Devices
2024/5
(+3 yr) Until 2024-May-26 “Sell Off” (1yr)
MDR Devices
UDI on Labels
UDI on Products
Class III 2023 Class IIa/b 2025 Class I 2027
Class III 2021 Class IIa/b 2023 Class I 2025
Place on Mkt: Class I Self-Cert by DoA, others upon NB Cert
2025/6
(+3yr) Until 2025-May-26
Legacy Place on Market Legacy IVDs
“Sell Off”
(1yr)
+1yr each
“First Cert” Place on Market Class D 2025, Class C 2026, Class B & A/s 2027
UDI on Labels
IVDRs
Class D 2023 Class B/C 2025 Class A 2027
Place on Mkt: Class A Self-Cert by DoA, “New IVD” upon NB Cert

17. EU MDR/IVDR – UDI Compliance Dates
© 2022 Reed Tech 17
Device Class
UDI Data Reported
to EUDAMED*
UDI On
Label
UDI Direct Mark
on Reusable
MD-Class III &
Implantables
2024-Q4 – 2026-Q2 2021-May-26 2023-May-26
MD-Class IIa & IIb Same 2023-May-26 2025-May-26
MD-Class I Same 2025-May-26 2027-May-26
IVD-Class D Same 2023-May-26 ~~~
IVD-Class B & C Same 2025-May-26 ~~~
IVD-Class A Same 2027-May-26 ~~~
Report UDI data to EUDAMED within 18 months after the DoA (if ready) or after EUDAMED Launch + 6m Delay*
and before placing a device on the market thereafter
* 18m Transition Period Or upon a need to report a serious incident (2,10,15 days)

18. EU UDI – Components
© 2022 Reed Tech 18
The globally unique, numeric or alphanumeric UDI code consisting of two parts is
generated by the owner per an approved Issuing Agency standard:
UDI = DI + PI
(01)00855361005016
Production Identifier (PI)*
Conditional, variable portion that identifies one or
more of the following when included on a device label:
Manufactured Date* 2014-09-24
Expiration Date 2019-09-24
Lot or Batch Number B35
Serial Number S123
Software ID* V22
Device Identifier (DI)
Mandatory, fixed portion
that identifies the labeler
and the specific version or
model of a device
00855361005016
GS1 UDI example * FDA adds DIN; EU Mfg conditional, adds Sfw ID
(11)140924(17)190924(10)B35(21)S123

19. EU EUDAMED Database
Submit Basic-UDI & Device attributes
(111 total) to EUDAMED
SOPs/Reports/Retention
• Include UDI in Annual Reports, Post Mkt
Surveillance, Patient Implant Card
• Comply with electronic records (Annex 11)
• Retain technical docs 10y (15y implants)
Label
• Apply UDI (Device Id + Production Id) on
Device Product and Package labels
• Present UDI in human-readable plain-text &
Automatic Id and Data Capture (AIDC) technology
(e.g., 1D/2D barcode, RFID)
Direct Mark (DM)
Permanently mark UDI on reusable devices (by
same or different patients) requiring cleaning,
disinfection, sterilisation or refurbishing between
uses
EU UDI Requirements
© 2022 Reed Tech 19

20. EU MDR Label Sample
© 2022 Reed Tech 20
Source: PRISYM ID
Enlarged views
of PI and UDI
MDR Label Elements:
• “MD” symbol (new)
• Warnings
• eIFU URL
• UDI (new) …
UDI presented in human-
readable plain-text and
Automatic Id and Data Capture
(AIDC) technology (e.g., 1D/2D
barcode, RFID)

21. Identification
Basic UDI-DI
Issuing Entity
Model Info
Device Model
Device Name
*System/Pack
**Kit (y/n)
Special Device
Organization
Mfr SRN
Auth Rep SRN
EU EUDAMED: UDI Data “MDR/IVDR Group” Basic UDI-DI (36 total)
© 2022 Reed Tech 21
Regulatory
Legislation
Risk Class
Clinical Invest. #
Clinical Invest. Link
CI Non-EU Countries
Cert Type
Cert #
Cert Revision #
Cert Date
Cert Notified Body #
Characteristics
Animal Tissue/Cell (y/n)
Human Tissue/Cell (y/n)
*Active Device (y/n)
*Implantable (y/n)
*Measuring (y/n)
*Reusable Surgical (y/n)
*Admin Medicine (y/n)
*Medicinal Product (y/n)
*Human Blood/Plasma (y/n)
*Suture, Staple, Filling… (y/n)
**Reagent (y/n)
**Instrument (y/n)
**Companion Diagnostic (y/n)
**Near Patient Test (y/n)
**Patient Self Test (y/n)
**Professional Testing (y/n)
**Microbial Tissue/Cell (y/n)
Common 19
*MDR Only 9 (28 total)
**IVDR Only 8 (27 total)
Data Dictionary v2.7

22. Identification
Basic UDI-DI
UDI-DI
UDI-DI Issuing Entity
Sec UDI-DI, Iss Entity
UoU UDI-DI, Iss Entity
DM UDI-DI, Iss Entity
Related Legacy Device
Relationship Type
Device Info
Trade Name+
Reference/Catalog #
Product Description+
Info URL
Product Designer
(Original Mfr)
PD SRN
PD Name
PD Street Name, #
PD Addr Complement
PD PO Box, City
PD Postal Code
PD Country
PD Phone, Email
Packaging
Base Device Quantity
Pkg UDI-DI, Iss Entity
Pkg Level Quantity
Pkg Contain UDI-DI
Pkg Status
Production ID Type
EU EUDAMED: UDI Data “MDR/IVDR Device” UDI-DI (75 total)
© 2022 Reed Tech 22
Regulatory
Device Status
Device Substatus, Start, End
Recall Precision+, Scope
MS Place on Mkt
MS(s) Made Available,
Start & End Dates
Nomenclature Code
**New Device (y/n)
*Non-medical Purpose
Characteristics
*Clinical Size Type
*Clinical Size Precision
*Clinical Size Range Max, Min
*Clinical Size Value (single)
*Clinical Size Unit
*Clinical Size Text
*ClinSize Other Type Descrip+
*ClinSize Other Unit Descrip+
Storage & Handling Type
S&H Description+
*Medicinal Type, Name+, INN
*Reprocessed SUD (y/n)
Safety Info
Max # Reuses
Labelled Single Use (y/n)
Labelled Sterile (y/n)
Sterile Req'd For Use (y/n)
*Containing Latex (y/n)
*CMR Type, Name+, CAS#, EC#
*Endocrine Name+, CAS#, EC#
Critical Warning/Contra-
Indications Type, Text+
Comm 47 + 5 Lang+ = 52
*MDR 17 + 5 Lang+ = 22
**IVDR 1 + 0 Lang+ = 1
Data Dictionary v2.7

23. Basic UDI-DI – GS1 Implementation
© 2022 Reed Tech 23
GS1 “Global Model Number” (GMN) for Regulated Healthcare Medical Devices (BUDI-DI)
• GS1 General Spec – search “GMN”; EC-GS1-BUDI-DI – change notice for GMN
GS1 GMN Generator – creates 2 check chars
• GMN created by brand owner, not to be reused, 25 max characters, no spaces,
GS1 Company Prefix + Model Refer (alphanum, A-z/0-9, no special characters) + 2 check characters
GMN
format
UDI-DI 0 0855361005 01 6
(GTIN-14)
Indicator
Digit
Item
Ref
GS1 Company
Prefix
Check
Digit
Device
Identifier
format
BUDI-DI 0855361005 MyModelRef342 A7
(25 max)
Model
Reference
GS1 Company
Prefix
2 Check
Char
No
Barcode

24. UDI-DI: ...
UDI-DI: 00855361005030 Forceps, SS, Locking
Basic UDI-DI Group Example
© 2022 Reed Tech 24
UDI-DI: 00855361005023 Forceps, SS
PKG-DI: 20855361005010 Forceps, Box - Qty 2
PKG-DI: 10855361005013 Forceps, Pouch - Qty 3
UDI-DI: 00855361005016 Forceps, Plastic
BUDI-DI: 0855361005MyForceps59

25. EU UDI Implementation Summary
© 2022 Reed Tech 25
• Collect EUDAMED UDI Data
• Normalize and Validate EUDAMED UDI Data
2. UDI Data Prep
• Create Global UDI Governance Team
• Identify EU UDI Requirements for Your Products
• Evaluate Your Situation
• Prepare EU UDI Environment/Processes with Global Expansion
• Select and Implement UDI Data and Labeling Systems
1. UDI Process Prep
• Start Production and Maintain Data & Systems
• Prepare for International UDI
5. UDI Operation
• Prepare Labeling Environment
• Test Labels, Verify Barcodes
4. Labeling System
• Create EUDAMED Account
• Submit EUDAMED UDI Data
• Verify EUDAMED UDI Submission and Publication
3. EUDAMED UDI
Submission

26. UDI Lessons Learned / Best Practices
© 2022 Reed Tech 26
• Think Globally
• Make EU part of your global, master UDI Data Solution
• Start Early & Watch for Updates
• Learn EU MDR/IVDR UDI policy, requirements, timing, etc.
• Create EUDAMED account – Actor Module (SRN)
• By DoA: assign Basic UDI-DI and UDI-DI to products and
Self-certify MDR Class I / IVDR Class A devices
• Start product certification using NBs
• Prepare Infrastructure and UDI Data
• System upgrades can be time consuming
• EU UDI dataset has twice the number of US UDI attributes and is more complex
• Data collection and cleansing always seems to take longer than expected

27. Regional Health Authorities
UDI Implementation Notecards
© 2022 Reed Tech 27

28. U.S. – FDA
© 2022 Reed Tech 28
2013-Sep-24 Final Rule published
2022-Jul-25 GFI Class I dates extended to 2022,
Class I OTC GUDID Exception
Events
2014-Sep-24 Class III Devices
2015-Sep-24 I/LS/LS Devices
2016-Sep-24 Class II Devices
2022-Sep-24 Class I Devices (label, direct mark)
2022-Dec-08 Class I Devices (GUDID)
• Approach: UDI data reported & on labels by
class; no change to device approval/registration
• Database: GUDID; functional; 3+M 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
I/LS/LS = Implantable, Life-Supporting, Life-Sustaining Devices; GFI = Guidance For Industry

29. EU – EC
© 2022 Reed Tech 29
2021-May-26 MDR DoA
2022-May-26 IVDR DoA
2024-Q2 EUDAMED “Functional” Notice
(6 modules fully functional)
Events
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
2024-Q4 Legacy, MD, IVD: UDI/Device
Reg Mandate Start (notice+6m)
2026-Q2 Legacy, MD, IVD: UDI/Device
Registration Deadline (notice+24m)
Compliance Timing
• Approach: new regulations for approval, reg,
UDI data/labels, vigilance, etc.; rules & timing
for Legacy Directive, MDR, IVDR devices
• Database: EUDAMED 3 modules open (Actor,
UDI, Cert); 3 future (Vigilance, CI, Mkt Suv)
• Data: 111 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

30. South Korea – MFDS
© 2022 Reed Tech 30
2016-Dec Medical Device Act revised (UDI)
2019-Jun UDI System introduction
Events
Date UDI Trace & Trace
2019-Jul-01 Class IV* ~~~
2020-Jul-01 Class III Class IV**
2021-Jul-01 Class II Class III
2022-Jul-01 Class I Class II
2023-Jul-01 ~~~ Class I
• Approach: device UDI data/labels by class;
AND Supply Report (Track & Trace) of ~10
distribution metrics each month
• Database: IMDIS (Integrated Medical Device
Information System), no Pre-production
• Data: 40 attributes; 15 auto populated by MFDS
in initial XLS dnload; 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, IMDIS UDI System
Description
MFDS – Ministry of Food and Drug Safety
Compliance Timing
* Report data by Oct ** Enforcement discretion to EOY 2020

31. China – NMPA
© 2022 Reed Tech 31
2019-Jul-03 UDI Batch 1 pilot notice & guide
2019-Sep-17 Batch 1 Notice 2020-10-01 and list
2020-Sep-30 Batch 1 Notice delay 2021-Jan-01;
69 (64+5) categories
2021-Sep-26 Batch 2 Notice due 2022-Jun-01
Events
2021-Jan-01 Batch 1 UDI data & label req’d
2022-Jun-01 Batch 2 Remaining Class III
TBD (2024?) Class II
TBD (2026?) Class I and Remaining
• Approach: device UDI data/labels; start with
“Batch 1” class III devices, then by class; early
adoption by some Provinces and Hospitals
• Database: UDID; 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; need local rep
• 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

32. Saudi Arabia – SFDA
© 2022 Reed Tech 32
2019-2020 UDI Pilot
2020-Sep-06 Formal Guidance (V3) released
2020-Oct-01 UDI Database open (voluntary)
2021-Oct-26 UDI Compliance Dates delayed
2022-Jun-24 UDI Compliance Dates delayed
Events
• Approach: device UDI data/labels by class;
(Import and Track & Trace modules on hold)
• Database: Saudi-DI; 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
2023-Sep-01 Class D (high risk)
2023-Sep-01 Class B & C (medium risk)
2024-Sep-01 Class A (low risk)
+1 year Direct Mark

33. Australia – TGA
© 2022 Reed Tech 33
• Approach: device UDI data/labels by class; plan
based on US with EU concepts
• Database: AusUDID
• Data: ~30 high-level proposed attributes;
similar to US/EU (includes BUDI-DI?)
• Sub: website entry or M2M transfer
• Label: HRI & AIDC (1D or 2D), Direct Mark (DM)
• STD: GS1, HIBCC, ICCBBA; GMDN (EMDN?)
• Info: TGA Medical Device & IVD
Description
TGA – Therapeutic Goods Administration
Compliance Timing
2022-Jul-04 AusUDID Sandpit (test, general use)
2023-Jan Vol. Compliance (high risk II, III, AIMD)
2024-Jul Req’d Compliance (Implants)
(UDI labeling, UDI data)
2019-Jan-07 UDI System Proposal
2019-Apr-04 UDI Action Plan
2020-Sep-23 UDI Consultation Survey
2021-Feb-19 Therapeutic Goods Amend
establish AusUDID
2022-Q3/Q4 Consultation #3
2023-Jan? Regulations & Guidance
Events

34. Reed Tech SingleSourceTM
For Medical Devices
© 2022 Reed Tech 34
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 health authorities
and supply chain partners.
FDA
SingleSource
• Import Data
Validate, Transform
• Process Workflow
Edit, Review, Approve
• Export Data
Mfr
GS1 GDSN Trading Partners
NHS England, NL, GPOs,
Hospital Networks, …
Health Authorities
China, South Korea,
[Saudi Arabia, Australia, …]
FDA GUDID
EU EUDAMED
(GDSN via a separate platform)

35. Reed Tech Educational Resources
© 2022 Reed Tech 35
ReedTech.com > Resources > Knowledge-Center
Follow Reed Tech Life
Sciences for new
content and events
@ReedTechLifeSci

36. For more information, contact:
Reed Tech Life Sciences Team
MedDevice@ReedTech.com; gsaner@ReedTech.com
+1-215-557-3010
www.ReedTech.com
© 2022 Reed Tech 36

37. Thank you !
© 2022 Reed Tech 37

38. Appendix
© 2022 Reed Tech 38

39. EC MDR/IVDR Resources
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• Public Health > Medical Devices
• Medical Devices - Sector
• Overview
• New Regulations
• MDR (EU) 2017/745
• IVDR (EU) 2017/746
• Regulation 2020/561 extending certain
provisions MDR (EU) 2017/745 by 1 year
• Medical Devices - New Regulations
• Overview
• Getting Ready
• Guidance
• MDCG – Guidance Site
• In Vitro Diagnostics
• Dialogue between interested parties
• Topics of Interest
• UDI
• EUDMAED Information and Sites
• Overview (includes Plan, DTX)
• Actor Registration Info
• UDI/Devices Registration Info, Dataset
• UDI Help Desk
• EMDN Q&A
• Legacy
• EUDAMED – Restricted Site
• EUDAMED – Public Site
• EC MDR/IVDR Factsheets
• For Manufacturers
• Step-by-step guide for medical device manufacturers
• Class I - Medical Devices

40. FDA Global UDI Database
(GUDID)
• Submit device UDI information to GUDID,
57 attributes including DI
• NLM public portal at AccessGUDID
SOPs/Reports/Retention
• Include UDI in Annual Reports, DHR,
Complaints, MDR, Recalls, Service,
Tracking, Post Market Surveillance
• Comply with electronic records (21 CFR 11)
• Retain records 3 years after discontinuation
Label
• Apply UDI (Device Id + Production Id) on
Device Product and Package labels
• Present UDI in human-readable plain-text &
Automatic Id and Data Capture (AIDC) technology
(e.g., 1D/2D barcode, RFID)
• Use Date Format YYYY-MM-DD (e.g., 2013-09-24)
(except AIDC date must use Issuing Agency date format)
Direct Mark (DM)
Permanently mark UDI on device if
multiple-use (different patients) and reprocessed
(high-level disinfection and/or sterilization)
FDA UDI Requirements
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41. Class I
Class I Label
Data in GUDID
& UDI on Label
UDI Direct Marking4
1) FDA UDI Final Rule published 2013-09-24
2) Class I UDI Label and Direct Mark = 2022-09-24, GUDID Submission = 2022-12-08
3) I/LS/LS = Implantable, Life-supporting, and Life-sustaining devices
4) Direct Marking (DM) required if multiple patients and undergo high-level disinfection and/or
sterilization between use
2014-09 2015-09 2016-09 2020-09
Final Rule
1
2022-09
2018-09
II Kits
Class II
I/LS/LS3
Class III
II Kits
Class II
Class III
All LS/LS3
/ 12
2
Class I
GUDID
FDA UDI Compliance Timeline
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FDA Final Rule
3
2
1 4

42. FDA UDI Label Example
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Source: FDA
Device ID Production IDs

43. FDA UDI Label Example (Class I UPC)
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Source: GS1
Class I UPC = UDI
(no Production Ids)
Date Format
YYYY-MM-DD

44. Identification
Pri DI Issuing Agency
Primary Device Id #
Brand Name
Version/Model #
Catalog #
Device Description
Sec DI Issuing Agency
Secondary DI #
Prev DI Issuing Agency
Previous DI #
DM Exempt (Y/N)
DM DI Different (Y/N)
DM DI #
Labeler
Labeler DUNS #
Labeler Name+
Labeler Address+
Contact Phone
Contact Email
Regulatory
Publish Date
Distribution End Date
Distribution Status+
GMDN Code
GMDN Name+
GMDN Definition+
FDA Product Code
FDA Product Code Name+
Premrkt Exempt (Y/N)
Premrkt Submission #
Supplement #
FDA Listing #
Rx (Y/N)
OTC (Y/N)
Production Control
Lot/Batch # (Y/N)
Serial # (Y/N)
Mfg Date (Y/N)
Expiration Date (Y/N)
Donation Id # (Y/N)
Characteristics
Kit (Y/N)
Combo Product (Y/N)
HCT/P (Y/N)
Size Type
Size Value
Size Unit
Size Text
Storage & Handling Type
S&H Low value
S&H High Value
S&H Unit
Storage Conditions
US FDA GUDID: UDI Data (64 total)
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57 Submitted by Labeler
7 Populated by FDA (+)
Packaging
Device Count
Unit of Use DI #
Pkg DI #
Pkg Quantity
Pkg Contains DI #
Pkg Type
Pkg Discontinue Date
Pkg Status+
Safety Info
Single Use (Y/N)
Contains Rubber (Y/N)
Not Made with Rubber (Y/N)
MRI Safety Status
Sterile Pkg (Y/N)
Sterile Req'd (Y/N)
Sterile Method