2021-Mar-15

MEDICAL DEVICE QUALITY IS ALL WE DO,

AND WE’RE ALWAYS AHEAD OF THE GAME.

“Great eQMS
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years industry podcast listeners blog and podcast look to us for the “The software is easy to use with little
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been a great tool for developing our
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FEATURED IN over the years, this is the best by
far!”

“My QMS is world “Design controls

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team”
About Reed Tech
Preparation, Submission, and Lifecycle Data Management of
Medical Device UDI product information
Industry Experts
15+ years of SPL knowledge (SPL-UDI since 2014); up-to-date SME knowledge from
guidance, pilots, and trade groups (MedTech Europe UDI & GS1 committees, etc.)
Proven, Current, Compliant Systems (21 Part 11, Annex 11, Audit Trail)
540,000+ SPLs submitted to FDA GUDID; 2,500+ records to EU EUDAMED
FDA ESG AS2 & EU DTX AS4 connection for automated, bulk submissions

HL7 ISO Certified

Experienced, Major Industry Provider Member since 1998
31% of all FDA GUDID SPL records since 2005 (9001:2015)
Roadmap to support international UDID submissions
1 World GS1
Trusted Team Partner Sync Solution
370+ medical device customers Partner Partner
Small (1 record) to large (250,000 records) customers
1 of the 3 largest medical device manufacturers in the world MedTech The Vision
Over 10 customers have international users Europe Council
Member Consultant

© 2021 Reed Tech 3

Presenters

John Lorenc
Director, Product Management
Medical Devices
Reed Tech

Gary Saner
Sr. Manager, Information Solutions
Life Sciences
Reed Tech

© 2021 Reed Tech 4

Discussion Topics

EU EUDAMED & Device Module Background and Timing

How to Prepare and Comply with UDI/Device Registration

Lessons Learned & Reed Tech Experience

Questions and Answers

© 2020 Reed Tech 5

Questions?

Please submit them any time using the

“Chat” Box.

They will be answered after the

presentation.

Enter Questions
in “Chat” Box

© 2021 Reed Tech 6

EU EUDAMED and Device Module
Background and Launch Timing

© 2021 Reed Tech 7

EU MDR/IVDR Description
Major EU Medical Device Regulatory Reform driven by:
• Recent incidents highlighting weaknesses in the framework
• New rules intended to restore confidence across the industry

EU Directives EU Regulations
Varying implementations in EU MS Legally binding across all EU MS
• Medical Devices Directive
(MDD) 93/42/EEC • Medical Devices Regulation
• Active Implantable Medical Device (MDR) 2017/745
Directive (AIMDD) 90/385/EEC
• In Vitro Diagnostic Directive • In Vitro Diagnostics Regulation
(IVDD) 98/79/EC (IVDR) 2017/746

© 2021 Reed Tech 8

Much to Do !!!
1. Pre-Assessment
2. Gap Analysis and Actions Sub-Projects
3. Quality Management System (QMS) • Clinical Evaluation
4. Legal Entities • Technical Documentation,
5. Portfolio • Economic Operators’ Relations
6. Master Implementation Plan • Unique Device Identification
7. Notified Bodies • Registration
8. Regulatory Training • Labelling
9. Execute Master Implementation Plan • Post-market Surveillance
10. Review Efficiency and Effectiveness • Vigilance
• Reporting IT Systems
11. Notified Body Submission
12. Ongoing Monitoring
Source: EC Implementation Model for MDR IVDR: More stringent rules. ~85% of all IVDs will need NBs
Step by Step Guide oversight. New post-market performance follow-up, etc.
© 2021 Reed Tech 9
EU UDI Requirements
Label
• Add UDI (Device Id + Production Id) on Device Label & Pkg
• Present UDI in human-readable plain-text and Automatic Id
and Data Capture (AIDC) technology (e.g., 1D/2D barcode, RFID)

Direct Marking (DM)

• Permanently mark UDI on reusable devices

EU UDI Database (EUDAMED)

• Submit DI and device attributes (102+ total) to EUDAMED

Reporting – Include UDI in Annual Reports,

Post Marketing Surveillance, Patient Implant Card

© 2021 Reed Tech 10

EU EUDAMED
Public

EUDAMED
(6 Modules)

Economic UDI/ Certificates Clinical Vigilance Market

Operators Devices & Notified Investigations & Post-Mkt Surveillance
(Actors) Bodies & Perf Studies Surveillance

MF PR
All AR IM NB EC SP CA MF CA EC

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
© 2021 Reed Tech 11
EU EUDAMED Timeline

2020-Dec-01: EUDAMED Actor Module (vol)

2021-Sep-26: EUDAMED UDI/Device Reg & Cert/NB Modules (vol)

TBD?: EUDAMED Vigilance, Clin Invest, Mkt Surv Modules (vol)

2022-May-26: EUDAMED Launch (fully functional)

6m 18m
2022-Nov-26 to Register Legacy, MDR, IVDR
2024-May-26: Reg Or upon Serious Incident

2020 2021 2022 2023 2024 2025 2026 2027

2021-May-26: MDR 2022-May-26: IVDR As of 2021-Mar-15: MDR DoA 1y delay,

Date of Application Date of Application EUD 2y delay, EUD Production vol sub

© 2021 Reed Tech 12

European Commission EUDAMED Roadmap
2020-Sep • Actor Module
2020-Dec • Actor Module
• Devices (UDI) Module Part 1
2021-Mar-31
• Certificates Module Part 1
2021-Jul • Devices (UDI) Module Part 2
• Certificates Module Part 2
2021-Sep-26 • Devices (UDI) Module
• Certificates Module
2021-Q3 Confirm Roadmap for:
• Vigilance Module
• Clinical Investigation Module
• Market Surveillance Module
2022-May-26 • Vigilance Module
• Clinical Investigation Module
• Market Surveillance Module
© 2021 Reed Tech
Pre-Production “Playground” Environment
• Available to EUDAMED DTX Working Group (initially)
• Reed Tech is active tester, as part of MedTech Europe
• Expect the following, prior to UDI module playground releases:
• Updated UDI data dictionary (MDR Devices, System and
Procedure Packs, and Legacy (MDD) Devices)
• Confirmation of M2M use cases supported in initial launch
• Business rules/technical specs associated with initial launch
• EU Commission confirming development and release roadmap
for remaining modules in Q3 2021
• Full system audit leading up to May 2022
Production Environment
• Available for voluntary (real) submissions
• Full functionality of all EUDAMED modules by May 26, 2022
EUDAMED Public Site is Live!
https://ec.europa.eu/tools/eudamed/#/screen/home
13
How to Prepare and Comply
UDI 101
EU Device Registration

© 2021 Reed Tech 14

What is UDI?
UDI is a globally unique, numeric or alphanumeric code consisting of two parts.
Device Identifier (DI) Production Identifier (PI)
Mandatory, fixed portion Conditional, variable portion that
that identifies the labeler identifies one or more of the following
and the specific version or when included on the label of a device:
model of a device Manufactured Date 2014-09-24
Expiration Date 2019-09-24
Lot or Batch Number B35
00855361005016
Serial Number S123
Software ID* V24

UDI = DI + PI
(01)00855361005016(11)140924(17)190924(10)B35(21)S123(8012)V24
* EU includes Software ID as separate PI © 2021 Reed Tech 15
How is UDI Represented?
UDI = DI + PI

Device ID Production IDs

AIDC (typical barcode) Text (HRI) Standard

1D (GS1 128, EAN/UPC) GS1, HIBCC, ICCBBA, (IFA)
or 2D (GS1 DataMatrix) 1 or multiple lines

*+X999123ABC0
/$$3140102A1234/S1234/16D20100102J*

AIDC = Automatic ID and Data Capture © 2021 Reed Tech HRI = Human Readable Interpretation 16
How Does UDI Appear
EU MDR Label?
Enlarged views
MDR Label Elements: of PI and UDI
• “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)
Source: PRISYM ID © 2021 Reed Tech 17
4 C’s of UDI/Device Registration

4. Comply with Regulations

3. Cleanse Data

2. Collect Data

1. Create Environment

© 2021 Reed Tech 18

UDI Implementation – Quick Checklist (1/4)
Step 1 – Create UDI Environment
Status Activity Details
• Secure management approval/support
 A. Create UDI Team • Assemble and train cross-functional
governance team and lead
• Research regulations
B. Identify UDI Requirements
 • Identify applicable rules, timing,
for Your Products
exceptions, and extensions
• Identify current infrastructure, perform
 C. Evaluate Your Situation
gap analysis

© 2021 Reed Tech 19

MDR / IVDR - 3 Categories of Devices

MDD/AIMDD/IVDD Devices
Directive devices discontinued as of DoA

Legacy Directive Devices

Directive devices continued to be placed on market

MDR/IVDR Compliant Devices

Regulation devices placed on market

© 2021 Reed Tech 20

EU MDR/IVDR UDI Timeline Summary
2022-Nov-26 to Register (18m)
IVDR Devices 6m 2024-May-26
UDI on
Class D 2023 Class B/C 2025 Class A 2027 Labels

2022-Nov-26 to
Legacy IVDD Devices Register (18m)
6m 2024-May-26
Place on Market (+2yr) Until 2024-May-26 2024/5 “Sell Off” (1yr)

Place 2022-Nov-26 to Register (18m)

on 6m 2024-May-26 UDI on Products
Mkt
Class III 2023 Class IIa/b 2025 Class I 2027
UDI on MDR Medical
Class III 2021 Class IIa/b 2023 Class I 2025 Labels
Devices
2022-Nov-26 to
Register (18m) Legacy Medical
6m 2024-May-26
Place on Mkt (+3 yr) Until 2024-May-26 2024/5 “Sell Off” (1yr) Devices

2020 2021 2022 2023 2024 2025 2026 2027

2021-May-26: MDR 2022-May-26: IVDR Date of Application
Date of Application 2022-May-26: EUDAMED Launch
* Register prior to serious incident report (2,10,15 days) © 2021 Reed Tech 21
UDI Implementation – Quick Checklist (1/4)
Step 1 – Create UDI Environment (continued)
Status Activity Details
• Identify tasks, resources, and timing to
 D. Create UDI Plan deliver infrastructure and procedures and
train people to meet requirements
• Implement new/enhanced Product Id,
 E. Prepare UDI Infrastructure
PLM/MDM/ERP systems, Labeling, SOPs…
• Evaluate, select, and implement data
mgm’t and submission solution to
 F. Establish UDI Data Solution
EUDAMED (manual entry, XML file
upload, M2M Data Exchange)

© 2021 Reed Tech 22

EU – UDI Data Submission Methods
Manufacturer Manual Data Entry
Web
or XML File Upload
Interface

Manual XML EC
EUDAMED

Build XML

Buy XML
UDI/
Device
Module
My Sample Title

Rent XML

Hosted Software M2M

Data Exchange
(SaaS)
Access Point

© 2021 Reed Tech 23

UDI Implementation – Quick Checklist (2/4)
Step 2 – Collect UDI Data
Status Activity Details
• Subscribe and implement Issuing Entity
A. Setup Product ID
 standard (GS1, HIBCC, ICCBBA, or IFA)
Standard
• Review EMDN nomenclature
• Define and assign Basic UDI-DI groups
• Assign Device Identifiers to Products
B. Assign Identifiers (Primary, Secondary, Unit of Use, Direct

to Portfolio Marking, Package Levels)
• Define Production IDs for Batch /
Serialization / Dates (ensure uniqueness)

© 2021 Reed Tech 24

Basic UDI-DI – GS1 Implementation
GS1 “Global Model Number” (GMN) for Regulated Healthcare Medical Devices (BUDI-DI)
• GS1 General Spec – GMN definition; GS1 GMN Generator – creates 2 check chars
• GMN created by brand owner, not to be reused, 25 max characters, no spaces,
include two check characters (alphanumeric, no special characters)

GMN BUDI-DI 0855361005 MyModelRef342 A7

format (25 max) No
GS1 Company Model 2 Check Barcode
Prefix Reference Char

Device
UDI-DI 0 0855361005 01 6
Identifier
format (GTIN-14)
Indicator GS1 Company Item Check
Digit Prefix Ref Digit

© 2021 Reed Tech 25

Basic UDI-DI Group Example
BUDI-DI: 0855361005MyForceps59

UDI-DI: 00855361005016 Forceps, Plastic

PKG-DI: 10855361005013 Forceps, Pouch - Qty 3

PKG-DI: 20855361005010 Forceps, Box - Qty 2

UDI-DI: 00855361005023 Forceps, SS

UDI-DI: 00855361005030 Forceps, SS, Locking

UDI-DI: ...

© 2021 Reed Tech 26

UDI Implementation – Quick Checklist (2/4)
Step 2 – Collect UDI Data (continued)
Status Activity Details
• Locate “master” data sources and
determine quality
 C. Assemble UDI Data
• Collect current values, generate missing
values, enrich dataset
• Establish governance, quality control, and
 D. Establish Data Governance maintenance/update procedures
• Assign data stewards

© 2021 Reed Tech 27

EU EUDAMED: UDI Data Basic UDI-DI “Group” (36 Total)
Identification Regulatory Characteristics
Version #* Legislation Animal Tissue/Cell (y/n)
Issuing Entity Risk Class Microbial Tissue/Cell (y/n)
Basic UDI-DI Human Tissue/Cell (y/n)
Clinical Invest. # Human Blood/Plasma (y/n)
BUDI Info Clinical Invest. Link Medicinal Product (y/n)
Device Model Clink Version Reagent (y/n)
Device Name CI Non-EU Countries Active Device (y/n)
System/Pack/Kit Admin Medicine (y/n)
Special Device Cert Type Implantable (y/n)
Cert # Measuring (y/n)
Cert Revision # Reusable Surgical (y/n)
Organization Cert Date Companion Diagnostic (y/n)
Mfr SRN
Cert Notified Body # Near Patient Test (y/n)
Auth Rep SRN
Patient Self Test (y/n)
Auth Rep Comment*
Professional Testing (y/n)
36 Submitted by Mfr Instrument (y/n)
2 Populated by EC (*) Suture, Staple, Filling… (y/n)

© 2021 Reed Tech Data Dictionary v5 28

EU EUDAMED: UDI Data Device UDI-DI (76 total)

Identification Mfr/Designer Regulatory Characteristics

Version #* Mfr SRN Device Status, Date Clinical Size Type
Basic UDI-DI Mfr Name Device Substatus, Start/End Clinical Size Precision
UDI-DI, Issuing Entity Mfr Street Name, # Recall Precision+, Scope Clinical Size Max
Sec UDI-DI, Iss Entity Mfr Addr Complement MS Place on Mkt Clinical Size Min
UoU UDI-DI, Iss Entity Mfr PO Box, City MS(s) Made Available, Clinical Size Unit
DM UDI-DI, Iss Entity Mfr Postal Code Start/End Dates Clinical Size Text
Directly Marked (y/n) Mfr Country Nomenclature Code Storage & Handling Type
Related Legacy Device Mfr Phone, Email New Device (y/n) S&H Description+
Relationship Type OEM Applicable (y/n) Non-medical Purpose Medicinal Type+, Name, INN
Reprocessed SUD (y/n)
Device Info Packaging
Trade Name+ Base Device Quantity
Reference/Catalog # Pkg UDI-DI, Iss Entity
Safety Info
Product Description+ Pkg Level Quantity Max # Reuses CMR Type, Name+, CAS#, EC#
Info URL Pkg Contain UDI-DI Labelled Single Use (y/n) Endocrine Name+, CAS#, EC#
Pkg Status, Date Labelled Sterile (y/n) Critical Warning/Contra-
76 Submitted by Mfr Production ID Type Sterile Req'd For Use (y/n) Indications Type, Text+
1 Populated by EC (*) Containing Latex (y/n)
7 Language Specific (+) © 2021 Reed Tech Data Dictionary v5 29
UDI Implementation – Quick Checklist (3/4)
Step 3 – Cleanse UDI Data
Status Activity Details
• Ensure data is accurate, up-to-date, and
 A. Verify Data
complete
B. Normalize and Validate • Confirm values comply with regulatory

Source UDI Data format and specifications
• Implement version and change
C. Establish Version and management controls

Approval Controls • Implement approval workflow with
assigned roles

© 2021 Reed Tech 30

UDI Implementation – Quick Checklist (4/4)
Step 4 – Comply with Regulations
Status Activity
 A. Create Regulatory Accounts
 B. Submit UDI Data
 C. Verify Submission Success
 D. Maintain Data & Systems
© 2021 Reed Tech
Details
• Create EUDAMED accounts
• Submit records per transmission protocol
• Confirm successful acknowledgments
• Update/correct data records as necessary
• Release new product models with UDI
• Keep systems and regulatory knowledge
current
31
EU UDI/Device Registration Summary
• Create UDI Governance Team
• Identify UDI Requirements for Your Products
1. Create UDI • Evaluate Your Situation
Environment • Create UDI Plan
• Prepare UDI Infrastructure
• Establish UDI Data Solution

• Setup Product ID Standard

• Assign Identifiers to Portfolio
2. Collect UDI Data • Assemble UDI Data
• Establish Data Governance

• Verify Data
3. Cleanse UDI Data • Normalize and Validate Source UDI Data
• Establish Version and Approval Controls

• Create Regulatory Account

4. Comply with • Submit UDI Data
Regulations • Verify Submission Success
• Maintain Data and Systems

© 2021 Reed Tech 32

Lessons Learned
Reed Tech Experience

© 2021 Reed Tech 33

UDI Lessons Learned / Best Practices
• Think Globally
• Make EU part of your Global UDI Solution – avoid single-point solutions
• Move to a master data solution that can expand to other Health Authorities

• Start Early
• By MDR Date of Application (DoA):
• Assign Basic UDI-DI and UDI-DI to products
• Self-certify MDR Class I devices
• Create EUDAMED account – register in Actor Module now to receive SRN
• Prepare/collect Docs before registering
• AR must register before Non-Eu Mfr
• Avoid expected backlog of EC and NB support, Do what you can based on published info;
EC quote, “High number of devices on the market, Anticipated bottleneck in reviews by
notified bodies, Ongoing need to interpret certain provisions of the Regulations”

© 2021 Reed Tech 34

UDI Lessons Learned / Best Practices (cont’d)
• Watch for Updates
• EC MDR/IVDR implementation is subject to change!
• Expect EC and MDCG to frequently update timing and add guidance

• 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
• Prepare to leverage EUDAMED Playground once it opens to additional Mfrs

• Reed Tech can Help

• Access SME UDI knowledge, training, and industry news
• Collect and cleanse EU data using Reed Tech UDI templates and system
• Engage a global UDI data management and submission data hub

© 2021 Reed Tech 35

Reed Tech SingleSourceTM For Medical Devices
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.

Regulators
US, EU, China,
South Korea, ...
Mfr SingleSource
For Medical
Devices Trading Partners
NHS England, GPOs,
Hospital Networks, …

© 2021 Reed Tech 36

SingleSourceTM UDI Data Mgmt

Medical Channels
Device EU EUDAMED
SingleSource For Medical Devices
Mfr
U.S. FDA GUDID
Collect Transfer Import Process Export China NMPA UDID
- PLM - XLS or - Load - View/Edit - Package
- MDM XML File - Merge or Reload - Transmit
Future Regulators
- ERP (upload, - Transform - Review - Confirm S. Korea, Saudi Arabia ...
- Reg Affairs API, sFTP) - Validate - Approve Receipt GDSN Trading Partners
- Labeling - M2M
Feedback NHS England, GPOs,
Hospitals Networks …

© 2021 Reed Tech 37

SingleSource System Environments

SingleSource for Medical Devices EU EUDAMED

Preview System
- “Sandbox” Data
“Playground” (now),
- Test / Cleanse Data
UAT System (future)
- Uncontrolled (New Features)
Data - Pre-Production
Exch.
Pre-Production / UAT System - System Validation
- Controlled
Mfr - User Acceptance Test Data
- System Validation
- Controlled

Production System Production System

Data
- Official Data Exch. - Official Data
- Controlled - Controlled

© 2021 Reed Tech 38

EU UDI – Reed Tech Support

My local affiliate (Authorized Representative) handles UDI in that region, how can we all have
visibility into a single version of our UDI data?
A local user/affiliate can be assigned a role within the Reed Tech SingleSource™ for Medical Devices
system for active involvement in the data workflow. The scenario, control and visibility can be shared
between the corporate user and the local user. This dynamic provides a centralized view into the
data with transparency for both the corporate office and the in-country representative. A ‘team’
view streamlines visibility for better communications concerning data and the opportunity to export
UDI data into internal systems if needed.
© 2021 Reed Tech 39
Questions?

© 2021 Reed Tech 40

Resources

© 2021 Reed Tech 41

Reed Tech Educational Resources
ReedTech.com > Resources > Knowledge-Center

Follow Reed Tech Life Sciences for new content and events
@ReedTechLifeSci
© 2020 Reed Tech 42
For more information, contact:

Reed Tech Life Sciences Team

MedDevice@ReedTech.com
+1-215-557-3010
www.ReedTech.com

© 2020 Reed Tech 43

Thank you !

© 2021 Reed Tech 44

Appendix

© 2021 Reed Tech 45

EC Resources
• EU Regulations
• MDR (EU) 2017/745
• IVDR (EU) 2017/746
• Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices as regards the dates of
application of certain of its provisions

• EU MDR/IVDR Information & Guidance

• New MDR/IVDR Regulations - Overview
• New MDR/IVDR Regulations – Getting Ready
• MDCG MDR/IVDR - Guidance

• EUDMAED Information and Sites

• EUDAMED – Overview (includes link to Data Dictionary)
• EUDAMED – Actor Registration
• EUDAMED – Public Site

• Topics of Interest
• UDI

© 2021 Reed Tech 46

Reed Tech SingleSource UDI Data Mgmt Benefits
• Provides Confidence • Saves IT Resources
• Trusted, single master data repository • Uses external Reed Tech hosted platform
• Proven systematic approach ensures and Reed Tech accounts (ESG, DTX, API)
data quality, integrity, and security • Non-intrusive, external “Data Hub”
• Accurate, timely submissions connection to existing systems
supported by a knowledgeable, • Compliant Environment
experienced partner (US, EU, etc.) • Meets regulatory data handling
• Saves Time and version storage requirements
• Reduced time to comply (21 Part 11, Annex 11, Audit Trail)
• Reuses common attribute values • Future-Proof Solution
• Saves Costs • Specification updates
• System startup & maintenance $ • Scalable for additional
• Bulk electronic record processing data volume & global data recipients
(regulator & commercial GDSN channels)
© 2021 Reed Tech 47
Start UDI Early…
• UDI Foundation Activities
• Learn/act on UDI policy (Reed Tech SME, training) Benefits:
• Identify Your Product Requirements • Avoid Rush
• Promote Internal UDI Adoption, Train Stakeholders • Ensure Quality
• Advise/educate PLD Suppliers, Operation Logistics, Buyers • Reserve Resources
• Setup Systems, SOPs, Data Ownership, Governance, etc. for Pending Health
• Plan Global Data Hub Approach Authorities

• UDI Technical Activities

• Learn Dataset (Reed Tech training)
• Learn/exercise Reed Tech System Data Transfer and Navigation (Reed Tech training)
• Locate Internal Data Sources, Collect Data into Structure, Create Missing Fields
• Cleanse/validate Data per Reed Tech System
• Conduct Pilot, Test & Validate System, Prepare for Production
© 2021 Reed Tech 48
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 49

 EU – EC
Events
2021-May-26 Medical Devices DoA
2022-May-26 IVD Devices DoA;
EUDAMED Launch Notice
(6 modules fully functional)
Compliance Timing
2020-Dec-01 EUDAMED Actor module vol
2021-May-26 Class I self-cert req’d
2021-Sep-26 EUDAMED UDI/Device & Cert/NB
modules voluntary
2022-Nov-26 Legacy, MD, IVD: UDI/Device
Registration Mandate (notice+6m)
2024-May-26 Legacy, MD, IVD: UDI/Device
Registration Deadline (notice+18m)
EC – European Commission
Description
• Approach: new regulations for approval, reg,
UDI data/labels, vigilance, etc.; rules & timing
for Legacy Directive, MDR, IVDR devices
• Database: EUDAMED 6 modules; Actor (open),
UDI & Cert (2021-09); 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
© 2021 Reed Tech 50
 MDR Registration/UDI Summary
EUDAMED UDI
Device UDI on
Description/Qualification Distribution Registration Due Direct
Group Label
(Identifier) Mark
• Placed on market under MDD/AIMDD Only upon SI*
MDD Discontinued None None
• NOT placed on the market after DoA (Eudamed DI, ID)
• Has a valid MDD/AIMDD certificate with NB
Continue to
• Meets Directive reqm'ts with no significant Eudamed
be placed on
changes affecting design, purpose, safety, or Notice+24m
the market
effectiveness needing a revised certificate (May 2024)
Legacy after the DoA None None
• Complies with MDR post-market surveillance, OR upon Serious
until 2024
market surveillance, vigilance, and registration of Incident*
(“Sell off” in
economic operators and devices in place of (Eudamed DI, ID)
2025)
Directive reqm’ts
• New device placed on the market Eud. Notice+24m
After MDR 2021-III 2023-III
• Directive device with a significant change or (May 2024)
Compliance 2023-IIa 2025-IIa
MDR expired Directive certificate OR upon Serious
and 2023-IIb 2025-IIb
• Directive device without a Directive certificate Incident*
Registration 2025-I 2027-I
(Class I, except Is/m/r) (BUDI-DI, UDI-DI)
* Includes FSN= Field Safety Notice and
FSCA= Field Safety Correction Action © 2021 Reed Tech 51
 IVDR Registration/UDI Summary
EUDAMED UDI
Device UDI on
Description/Qualification Distribution Registration Due Direct
Group Label
(Identifier) Mark
• Placed on market under IVDD Only upon SI*
IVDD • NOT placed on the market after the DoA Discontinued None None
(Eudamed DI, ID)
• Has a valid IVDD directive cert
Continue to Eudamed
• Meets Directive reqm'ts with no significant
be placed on Notice+24m
changes affecting design, safety, or effectiveness
the market
needing a revised certificate (May 2024)
Legacy • Complies with IVDR post-market surveillance, after the DoA None None
until 2024 OR upon Serious
market surveillance, vigilance, and registration of Incident*
(“Sell off” in
economic operators and devices in place of (Eudamed DI, ID)
2025)
Directive reqm’ts
Eud. Notice+24m
• New device placed on the market After IVDR 2023-D
(May 2024)
• Directive device with a significant change or Compliance 2025-C
IVDR OR upon Serious None
expired Directive certificate and 2025-B
Incident*
• Directive device without a Directive certificate Registration 2027-A
(BUDI-DI, UDI-DI)
* SI = Serious Incident, FSN= Field Safety
Notice, FSCA= Field Safety Correction Action © 2021 Reed Tech 52
 EU MDR UDI Timeline Summary
2022-Nov-26 to Register (18m or upon a Serious Incident, FSN,
Place 6m 2024-May-26 FSCA; prior to placing on market thereafter)
on UDI Direct Mark on Reusables (May-26)
Mkt
Class III 2023 Class IIa/b 2025 Class I 2027
UDI on Labels (May-26) MDR Medical Devices
Class III 2021 Class IIa/b 2023 Class I 2025 New, Class I (except Is/m),
Changed/Expired Directive Cert

2022-Nov-26 to Register (18m or upon a

6m 2024-May-26 Serious Incident, FSN, FSCA)
Until 2024-May-26 May-26 Supply Chain
Place on Market (+3 yr) 2024/5 “Sell Off” (1yr)
By 2024-May-26 MDD/AIMDD Legacy Medical Devices
All Directive Certificates Expire Class Is/m, IIa/b, III Directive Cert

2020 2021 2022 2023 2024 2025 2026 2027

2021-May-26: MDR 2022-May-26:
Date of Application EUDAMED Launch

* Pending EU clarification © 2021 Reed Tech 53

 EU IVDR UDI Timeline Summary

In Vitro Diagnostic 2022-Nov-26 to Register (18m or upon a Serious Incident, FSN,

Devices 6m 2024-May-26 FSCA; prior to placing on market thereafter)
New, Changed/Expired
Directive Cert UDI on Labels (May-26)
Class D 2023 Class B/C 2025 Class A 2027

IVDD Legacy Devices 2022-Nov-26 to Register (18m or upon a

Directive Cert 6m 2024-May-26 Serious Incident, FSN, FSCA)
Until 2024-May-26 May-26 Supply Chain
Place on Market
(+2 years) 2024/5 “Sell Off” (1yr)
By 2024-May-26
Directive Certificates
All Dir. Certs. Expire

2020 2021 2022 2023 2024 2025 2026 2027

2022-May-26: IVDR Date of Application
2022-May-26: EUDAMED Launch
* Pending EU clarification © 2021 Reed Tech 54
EU Basic UDI-DI
“BUDI-DI” is a product group identifier for related medical devices, i.e., a product family
• BUDI-DI “parent” identifier includes one or more “child” medical devices (UDI-DI)
• Each medical device child (UDI-DI) has only one BUDI-DI parent
• All BUDI-DI attributes are common for the product group, i.e., same intended
purpose, risk class, design/mfg characteristics, certification
• Creation
• EU MDCG format reqm'ts: max 25 characters & include check digit/character
• Mfr creates BUDI-DI per Stds (GS1, HIBCC, ICCBBA, IFA) & independent of packaging
• Use
• Used in EU Documentation for Device Registration, etc. and for Trade Item
identification in EUDAMED
• BUDI-DI is different from and does not replace UDI-DI
• NOT used on any product labeling, physical marking, or AIDC data carrier
© 2021 Reed Tech 55
Regulators Are Adopting UDI
• U.S. (2014)
• EU (2021/2022)
• South Korea (2019)
• Netherlands (2020)
• UAE (2020)
• China (2021)
• Saudi Arabia (2021)
• Taiwan (2021)
• Australia
• Brazil
• Canada
• India
• Japan
• Malaysia
• Singapore
• Turkey Numerous Regulators have or will in the near
• UK future require product information in UDI standards
• Other
© 2021 Reed Tech 56
Past UDI Data Reporting Reqm'ts

2014 2015 2016 2017 2018 2019 2020

US – FDA Sep-III Sep-I/LS/LS Sep-II

UK – NHS England Sep-III Sep-IIa/b Sep-I

South Korea – MFDS Oct-IV Jul-III

Netherlands – LIR Jan-Incl. List

EU – EC Dec-EUD Actor (vol)

UAE – Dubai HA 2020-All? Devices

Brazil – ANVISA Jun-Implants UDI Pkg Insert

Japan – PMDA 2008-Device reg & barcode label (recommended)

Turkey – TMMDA 2004-Device reg & barcode label

 UDI Submission Deadline,  Milestone © 2021 Reed Tech 57

Short-Term UDI Data Reporting Reqm'ts
2021 2022
China – NMPA Jan-Batch 1 Oct-III
May- Sep-EUD UDI May-IVDR DoA, EUD launch
EU – EC
MDR DoA & Cert (vol) Nov-EUD UDI (reg start)
Taiwan – FDA Jun-III Implants Jun-III Others

South Korea – MFDS Jul-II Jul-I

Saudi Arabia – SFDA Aug-D Feb-B,C

UK – NHS England Sep-IVD A,B,C,D

US – FDA Sep-I

Singapore – HSA 2022-(3) Implants

UK – MHRA
Australia – TGA <obsolete?>
 UDI Submission Deadline,  Milestone
May-III, IIb Imp, Active Imp, IVD-A (device reg)
Sep-IIb other, IIa, IVD-B, IVD-Self Test (device reg)
Jan-I, IVD-General (device reg)
May-III
© 2021 Reed Tech 58
Long-Term UDI Data Reporting Reqm'ts
2023 2024 2025 Future
EU – EC
2022 Nov 2024 May-EUD UDI (18m reg period)
Saudi Arabia – SFDA Feb-A

Taiwan – FDA Jun-II

UK – MHRA Jun-GB stops recognizing CE mark & EU certs; Requires UKCA mark

Singapore – HSA 2024-D 2026-C 2028-B

China – NMPA Oct-II 2026 Oct-I
Australia – TGA
<obsolete?> May-IIa/b, IVD-4 May-I, IVD-2,3 2027 May-IVD-1

India – CDSCO 2022?-UDI

Canada Ecuador UK TBD-UDI

Japan Turkey TBD-UDI Database

 UDI Submission Deadline,  Milestone © 2021 Reed Tech 59

Glossary

© 2021 Reed Tech 60

 Medical Device UDI Glossary 1
1D One-Dimensional – (linear) barcode, e.g., EAN/UPC, GS1-128, Code 128, ITF-14
2D Two-Dimensional – barcode, e.g., GS1 DataMatrix, GS1 QR Code, Data Matrix, QR Code
AccessGUDID (NLM) AccessGUDID – website containing US FDA UDI data
ACK Acknowledgment – transmission confirmation
AI (GS1) Application Identifier – identifier of a product attribute (format and meaning)
AIDC Automatic Id and Data Capture – technology used for automated product identification (typically 1D/2D
barcode, RFID, near-field communication, etc.)
AIMDD (EU) Active Implantable Medical Device Directive 90/385/EEC
AR (EU) Authorized Representative (EU based entity for imported goods)
Basic UDI-DI (EU) Primary identifier of a device product group in the UDI database and is referenced in relevant certificates
and EU declarations of conformity, not used on a product label, (GS1 “BUDI-DI”)
CA (EU) Competent Authority
CDRH (FDA) Center for Devices and Radiological Health
CFR (FDA) Code of Federal Regulations
CS (EU) Common Specification
D&B Dun & Bradstreet, see DUNS
DHF Design History File
DHR Device History Record
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 Medical Device UDI Glossary 2
DI Device Identifier – see UDI-DI
DM Direct Marking – permeant identification on product implemented via various means including durable label,
DPM, or durable RFID tag
DM DI DM Device Identifier – DI associated with the device direct marking
DMR Device Master Record
DPM Direct Part Marking – marking a symbol on an item using an intrusive or non-intrusive method
DUNS (D&B) Data Universal Numbering System (D-U-N-S) – global standard for organization identification (9-digit #)
EAN European Article Number – renamed International Article Number, “EAN” retained, linear barcode symbology,
typical retail use OUS, includes EAN-8, EAN-13
EC (EU) European Commission
EDI Electronic Data Interchange
EHR Electronic Health Record
EPC (GS1) Electronic Product Code
ERP Enterprise Resource Planning
ESG (FDA) Electronic Submissions Gateway – agency-wide secure solution for accepting electronic regulatory
submissions
EUDAMED (EU) Medical Device database with 6 modules: Economic Operator (Mfr/AR/Imp Actor Reg), NB Reg &
Certificates, Device/UDI Reg, Clinical Investigations, Vigilance & Post-Market Surveillance, Market Surveillance
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 Medical Device UDI Glossary 3
FDA (US) Food and Drug Administration – includes CDRH
FNC1 Function Code 1 – invisible character, used to identify and separate barcode fields
FSCA (EU) Field Safety Corrective Action
FSN (EU) Field Safety Notice
FURLS FDA Unified Registration and Listing System – medical device establishment registration and product listing
GCP (GS1) GS1 Company Prefix – unique identifier for a subscribing party, used in GTIN-14
GDSN (GS1) Global Data Synchronization Network – communication standard that enables manufacturers to share
product information with their trading partners
GEPIR (GS1) Global Electronic Party Information Registry – information on parties’ GS1 Company Prefixes (GCP),
Locations (GLNs) and Trade Items (GTINs)
GFI (FDA) Guidance For Industry
GLN (GS1) Global Location Number – identifier for a unique physical address and business operation
GMDN Global Medical Device Nomenclature – standard terminology (codes, names, and definitions) of types of device
products
GMP Good Manufacturing Practice

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 Medical Device UDI Glossary 4
GMN (GS1) Global Model Number – identifier for a product model, i.e., group (GS1 “BUDI-DI” implementation of
“Basic UDI-DI”)
GPC (GS1) Global Product Classification
GPO Group Purchasing Organizations
GS1 GS1 – an international, not-for-profit association that develops global standards (e.g., barcodes, GTIN, GLN,
GDSN) to improve the efficiency and visibility of supply and demand chains across sectors; www.gs1us.org
GTIN (GS1) Global Trade Item Number – identifier for a product model/version
GUDID (FDA) Global UDI Database – registry of Medical Device DI and attributes
HIBC (HIBCC) Health Industry Bar Code – product identification standard
HCT/P Human Cell, Tissue, or Cellular or tissue-based Product (some regulated as device)
HIBCC Health Industry Business Communications Council – an international, non-profit organization that develops
electronic exchange standards (e.g., HIBC) for health care trading partners; www.hibcc.org
HL7 Health Level Seven – standards developing organization providing international healthcare information system
interoperability standards for the exchange, integration, sharing, and retrieval of information (e.g., SPL)
HRI Human Readable Interpretation – legible interpretation of the data characters encoded in the UDI carrier
HTG Health Transformation Group

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 Medical Device UDI Glossary 5
I/LS/LS Implantable, Life-Supporting, Life-Sustaining
IFU Instructions For Use
ICCBBA International Council for Commonality in Blood Banking Automation – international standards organization
(not-for-profit, nongovernmental) responsible for the ISBT 128 Standard; www.iccbba.org
IDE (FDA) Investigational Device Exemption
IMDRF International Medical Device Regulators Forum
Im (EU) Class I device with measuring function
Ir (EU) Class I reusable surgical instrument
Is (EU) Class I sterile device
ISBT 128 (ICCBBA) International Standard for Blood and Transplant
ISO International Organization for Standardization
Issuing Agency/Entity Standards Developing Organization approved by Health Authority (FDA/EC) to provide standard for
Medical Device UDI (GS1, HIBCC, and ICCBBA)
IVD In Vitro Diagnostic (device)
IVDD (EU) In Vitro Diagnostic Directive 98/79/EC
IVDR (EU) In Vitro Diagnostics Regulation 2017/746
Labeler (US) Person who causes a label (or modification) to be applied to a medical device; has UDI responsibilities

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 Medical Device UDI Glossary 6
MD Medical Device
MDCG (EU) Medical Device Coordination Group – MS representatives (and created expert working groups) provide
advice and assistance to the EC to ensure a harmonized implementation of MDR/IVDR
MDD (EU) Medical Devices Directive 93/42/EEC
MDM Master Data Management
MDR (EU) Medical Devices Regulation 2017/745
NB (EU) Notified Body – EU conformity assessment body designated in accordance with the MDR/IVDR Regulation
NLM National Library of Medicine – US NIH department hosting AccessGUDID website
NHS National Health Service – multiple UK health services for England, Scotland, Wales, and Northern Ireland
NMPA (China) National Medical Products Administration
OTC Over The Counter
PEPPOL Pan European Public Procurement On Line – messaging standard for electronic procurement including purchase
orders, advice shipping notices, and invoices
PI Production Identifier – see UDI-PI
PIM Product Information Management
PLD Private Label Distributor

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 Medical Device UDI Glossary 7
PLM Product Lifecycle Management
PMA (FDA) Pre-market Approval
PMCF (EU) Post Market Clinical Follow-up
PMS Post Market Surveillance
PPE Personal Protective Equipment
QMS Quality Management System
RFID Radio Frequency Identification – data carrier technology using radio signals includes transponder (tag) and
transceiver
Rx Prescription symbol
SaaS Software as a Service
SaMD Software as a Medical Device
SKU Stock Keeping Unit – identifier for a particular product
SRN (EU) Single Registration Number – EUDAMED Economic Operator identification
SOP Standard Operating Procedure
SPP (EU) System or Procedural Pack
SPL Structured Product Labeling – document markup standard (XML) approved by HL7 and adopted by FDA as a
mechanism for exchanging product information
SUD Single Use Device
© 2021 Reed Tech 67
 Medical Device UDI Glossary 8
UDI Unique Device Identifier = Device Identifier (DI) + Production Identifier (PI) per approved Issuing Agency that
allows the unambiguous identification of a specific device on the global market
UDI-DI UDI-Device Identifier – a static unique numeric or alphanumeric code specific to a device model/version:
uniquely identifies a company and product model/version; used as the ‘access key’ to information stored in a
UDI database
UDI-PI UDI-Production Identifier – a dynamic manufacturing numeric or alphanumeric code that identifies a particular
production unit or group; (FDA PI: mfg date, expiration date, batch/lot #, serial #, HCT/P code; EU PI: serial #,
lot #, software identification, mfg date, or expiry date (or both types of date))
UDI Carrier Means of conveying the UDI by using AIDC and, if applicable, its HRI
UoU Unit of Use – individual unit package administered to a patient
UoU DI UoU Device Identifier – associates the use of a device with a patient in instances in which a UDI is not labeled
on the individual device at the level of its unit of use, for example in the event of several units of the same
device being packaged together
UPC Universal Product Code – linear barcode symbology, typical retail use in US and Canada, includes UPC-A, UPC-E
UPC Company Prefix unique identifier for a subscribing party, used in GTIN-12 (UPC)
XML Extensible Markup Language – markup language defining a set of rules for document encoding in both human
and machine readable language

© 2021 Reed Tech 68

EU EUDAMED Abbreviations 1/2
• ACT Actor Module
• AR Authorised Representative
• CA Competent Authority
• CCA Coordinating Competent Authority
• CECP Clinical Evaluation Consultation Procedure
• CIP Clinical investigation plan (MD)
• CIPS Clinical Investigation / Performance Studies Module
• CMS Coordinating Member State
• CRF Certificates / Notified Body Module
• DA Designating Authority
• DTX Data Exchange Module
• EC European Commission
• EU MF European Manufacturer
• EUD LR or FS on the MDR Eudamed project level, covering all modules
• FS Functional Specification
• FSCA Field Safety Corrective Action
• FSN Field Safety Notice
• IAM Related to data protection LR or FS on the MDR Project Level, covering all modules
• LR Legal Requirement
• MS Member State
• MSC Member State concerned
• Note: For the purpose of this document the term ‘Member State’ is a synonymous of ‘Member State concerned’.
• MSU Market Surveillance Module
• NB Notified Body
• NFS Non – Functional Specification
• Non-EU MF Non-European Manufacturer
• PMCF Post market clinical follow up (MD)

© 2021 Reed Tech 69

EU EUDAMED Abbreviations 2/2
• PMPF Post market performance follow up (IVD)
• PSP Performance study plan (IVD)
• PSR Periodic Summary Report on serious incidents
• PSUR Periodic Safety Update Report
• SAE Serious adverse event
• SIR Serious Incident Report
• SIN Single Identification Number for a CIPS
• SPPP System/Procedure pack Producer
• SRN Single Registration Number for an economic operator
• SS(C)P Summary of Safety and (Clinical) Performance
• TR Trend Report
• UDID UDI / Device Module
• VGL Vigilance Module

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