Global standards: a must for UDI in the EU, and beyond
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Global standards: a must for UDI in the EU, and beyond Géraldine Lissalde-Bonnet, director public policy #GS1UDIForum
Transcript of Global standards: a must for UDI in the EU, and beyond
Global standards: a must for UDI in the EU, and beyond
Géraldine Lissalde-Bonnet, director public policy
#GS1UDIForum
Global standards: a must for UDI in the EU, and beyond
Géraldine Lissalde-Bonnet, Public Policy Director, GS1 Global Office
17 June 2021
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The benefits of UDI and of global
standards
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UDI: what is it?
Unique Device Identifier (UDI)
The UDI is a series of numeric or alphanumeric characters that is created through a
globally accepted device identification and coding standard. It allow the
unambiguous identification of a specific medical device on the market.
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Benefits of UDI for regulators
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Visibility (inventory)and documentation of devices placed on the market and used at point of care.
Market surveillance and customs control preventing dangerous and/or fake medical devices.
Information on devices and on usage to be leverages for insurance, price control, tender requirements, etc
A globally harmonisedsystem across borders, aligned with the IMDRFframework.
Please note: this is not an exhaustive list
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Benefits of UDI for manufacturers
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Tracking (inventory) and tracing of the individual product improves visibility to accurately plan production and distribution.
Brand and counterfeit protection preventing fake medical devices entering the supply chain.
Information on product usage and impact on patients (e.g., adverse events).
A safe and efficient supply chain with the help of standards build trust in the manufacturer and its products.
Please note: this is not an exhaustive list
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Benefits of UDI for healthcare providers
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Unambiguously identify medical
devices
Having access to accurate and up-to-
date product information, enable
eHealth records
More accurate reports of adverse
events and reduction of errors
Optimization of supply chain for purchase orders,
responses, invoices and other business
messages
More efficient product recalls and verification of the
legitimacy of medical devices
Please note: this is not an exhaustive list
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GS1 as UDI issuing entity in the EU
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• On 7 June 2019, GS1 was designated by
the European Commission as issuing entity
for Unique Device Identifiers (UDIs). Re-
assessed in 5 years.
• GS1 is part of the MDCG (Medical Device
Coordination Group – EU MS and EU COM)
on UDI and the MDCG on EUDAMED.
• Other regulators are allowing - planning to allow - the use of GS1
standards as the basis of their national UDI system e.g. Australia, Brazil,
China, Saudi-Arabia, Singapore, South Korea, Turkey.
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GS1 identifiers and UDI in the EU
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UDI and the GS1 System of standards
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In the EU:
Basic UDI-DI
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UDI in GS1 AIDC terms
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Requiredin the EU
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© Copyright GS1 AISBL, 2012-2021. All Rights Reserved.
Examples
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Device Identifier (DI)“Static” portion
GTIN (product identifier)
Production Identifier (PI)“Dynamic” portion
Application Identifiers
(e.g. lot number, expiry date)
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EUDAMED piece by piece
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UDI REGULATORY databases
Part that the U.S. FDA UDI system focuses on today...
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Source: EU Commission – March 2021
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Source: EU Commission - March 2021
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Source: EU Commission - March 2021
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Main challenges and lessons learned
• Multiple …modules, objectives, users, channels
• Heavily regulated
• Challenging interpretation
• COVID-19 delays
• Make sure you have the correct access profile (approved by a different
Local Actor Administrator)
• Consult documentation available : Overview | Public Health (europa.eu)
• Test your XML files using bulk upload: XML samples are available online
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Status and next steps
• Focus on Minimum Viable Product: minimum legal requirements
• Feedback for users to improve the system• Progressing in the following:
Actors, Devices and Certificates v1.2:• Playground by July 2021• Production by September 2021
• Development MIR Form & Documenting FCSA and FSN (Vigilance):• Development to start Q3/2021
• Requirements and Business Analysis CI/PS and MSU
• Constant review and update of the plan
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EU – UDI: EUDAMED timeframe – MDR*Timeframe subject to changes
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26 May 2022: EUDAMED officially releasedDeadline for MDR device registration to 26 May 2024
(18+6 months = 24 months after EUDAMED becomes fully functional). For more details: MDCG 2019-4 Timelines for
registration of device data elements in EUDAMED and transitional period FAQs
26 May 2021: MDR date of application
- UDI assignment (ie Basic UDI-DI & UDI)
- UDI labelling for implantables and for Class 3 Devices
1 December 2021Actor Registration Module to
be launched
2021 20222021
Until May 2022All registration in the modules released
remains voluntary. Member States decide which platform (national or
EUDAMED) they will use.
2023 …2025
26 May 2023
UDI labelling for Class IIaand IIb Devices
26 May 2025
UDI labelling for Class I Devices
+ 2 years for Direct Marking, when applicable
*IVDR application deadline: 26 May 2022
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© Copyright GS1 AISBL, 2012-2021. All Rights Reserved.
UDI system step by step
1. Assess what are the products falling under the MDR/IVDR scope
2. Assess what is the relevant Class for each type of product
3. Define/select one Issuing Agency
4. If GS1, contact your GS1 Member Organisation: assign a GS1 Company Prefix
and support on the generation and application of Basic UDI-Dis & UDI-DIs
5. Basic UDI-DI (GMN) and UDI (GTIN & AIs) assignment
6. EUDAMED registration
7. Barcodes and HRI (deadlines depending on the risk class)
8. Maintenance
The responsibility for compliance with the UDI requirements remains the entire responsibility of the GS1 user, not GS1
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UDI and the rest of the world
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Not only in Europe! Requirements for medical device identification
UK
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We are ALL dependent on an efficientsupply chain across countries and
continents
We need to be able to interact clearly and unambiguously with each other – using a
global language
We need to make sure that the resources and supplies needed are effectively made available
to support our health systems in the
best possible way
We need to prevent substandard and falsified products entering our
supply chains and markets, putting patients and caregivers at risk
GLOBAL STANDARDS ARE NEEDED
In these difficult times we
learned that…
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Thank you!
Safer, more efficient care starts with a simple scan!
http://www.gs1.org/healthcare/udi
Géraldine Lissalde-Bonnet
