Global standards: a must for UDI in the EU, and beyond - Géraldine Lissalde-Bonnet, director public policy
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
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
The benefits of UDI
and of global
standards
© GS1 2021 3
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.
© GS1 2021 4
Benefits of UDI for regulators
Information on devices and
Visibility (inventory)and on usage to be leverages
documentation of devices for insurance, price
placed on the market and control, tender
used at point of care. requirements, etc
Market surveillance and A globally harmonised
customs control preventing system across borders,
dangerous and/or fake aligned with the IMDRF
medical devices. framework.
Please note: this is not an exhaustive list
© GS1 2021 5
Benefits of UDI for manufacturers
Tracking (inventory) and
tracing of the individual Information on product
product improves visibility usage and impact on
to accurately plan patients (e.g., adverse
production and events).
distribution.
A safe and efficient supply
Brand and counterfeit
chain with the help of
protection preventing fake
standards build trust in the
medical devices entering
manufacturer and its
the supply chain.
products.
Please note: this is not an exhaustive list
© GS1 2021 6
Benefits of UDI for healthcare providers
More efficient Having access to
Unambiguously product recalls and accurate and up-to-
identify medical verification of the date product
devices legitimacy of information, enable
medical devices eHealth records
Optimization of
More accurate supply chain for
reports of adverse purchase orders,
events and responses, invoices
reduction of errors and other business
messages
Please note: this is not an exhaustive list
© GS1 2021 7
GS1 as UDI issuing entity in the EU
• 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.
© GS1 2021 8
GS1 identifiers and
UDI in the EU
© GS1 2021 9
UDI and the GS1 System of standards
In the EU:
Basic UDI-DI
© GS1 2021 10UDI in GS1 AIDC terms
Required
in the EU
© GS1 2021 11GS1 Healthcare GTIN Allocation Rules
© GS1 2021 12Examples
Device Identifier (DI) Production Identifier (PI)
“Static” portion “Dynamic” portion
GTIN (product identifier) Application Identifiers
(e.g. lot number, expiry date)
© GS1 2021 13
© Copyright GS1 AISBL, 2012-2021. All Rights Reserved.EUDAMED piece by
piece
© GS1 2021 14UDI REGULATORY databases
Part that the U.S.
FDA UDI system
focuses on today...
© GS1 2021Source: EU Commission – March 2021
© GS1 2021
16Source: EU Commission - March 2021
© GS1 2021
17Source: EU Commission - March 2021
© GS1 2021
18Main 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
© GS1 2021
19Status 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
© GS1 2021
20EU – UDI: EUDAMED timeframe – MDR*
Timeframe subject to changes
Until May 2022
All registration in the modules released
remains voluntary. Member States 26 May 2023 26 May 2025
decide which platform (national or
EUDAMED) they will use. UDI labelling for Class IIa UDI labelling for Class I
and IIb Devices Devices
2021 2021 2022 2023 …2025
26 May 2022: EUDAMED officially released
Deadline for MDR device registration to 26 May 2024 + 2 years for Direct Marking,
1 December 2021
(18+6 months = 24 months after EUDAMED becomes fully when applicable
Actor Registration Module to 26 May 2021: MDR date of application functional). For more details: MDCG 2019-4 Timelines for
be launched
registration of device data elements in EUDAMED and
- UDI assignment (ie Basic UDI-DI & UDI) transitional period FAQs
- UDI labelling for implantables and for
Class 3 Devices
*IVDR application deadline: 26 May 2022
© GS1 2021
21UDI 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
© GS1 2021
© Copyright GS1 AISBL, 2012-2021. All Rights Reserved.UDI and the rest of
the world
© GS1 2021 23Not only in Europe!
Requirements for medical device identification
UK
© GS1 2021In these difficult times we
learned that…
ALL dependent on an efficient
We are
supply chain across countries and
continents
We need to be able to interact clearly and
unambiguously with each other – using a
GLOBAL
global language
STANDARDS
ARE NEEDED 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
prevent substandard
We need to
and falsified products entering our
supply chains and markets, putting patients
and caregivers at risk
© GS1 2021 25Thank you!
Safer, more efficient care
starts with a simple scan!
http://www.gs1.org/healthcare/udi
Géraldine Lissalde-Bonnet
g.lissalde@gs1.org
© GS1 2021 26You can also read
