The ultimate guide to the EU MDR/IVDR unique device identifier (UDI) System
This article is an excerpt from The ultimate guide to the EU MDR/IVDR UDI ebook.
Table of contents
- Overview
- UDI basics and benefits
- UDI format requirements and issuing entities
- UDI rules for specific device types
- Implementation of UDI and UDAMED in the European Union
- US vs EU UDI comparison
The EU Medical Device Regulation (2017/745) (“MDR”) and EU In Vitro Diagnosis Regulation (2017/746) (“IVDR”) introduce two new systems for information exchange: UDI (Unique Device Identifier) for device identification and EUDAMED (European Databank on Medical Devices) to centralize and disseminate information. UDI is a specific code assigned to all devices and higher levels of packaging. This will allow for devices being sold in the European market to be identified and traced through a globally harmonized approach. EUDAMED is the IT system developed by the European Commission to replace the EUDAMED2 database previously in place under the Medical Device Directives (MDD). EUDAMED is a multi-functional system that will be used to coordinate device registration, provide information about devices to industry professionals and the public, and highlight necessary safety details.
The EU MDR and IVDR UDI system is based upon the guidance of the International Medical Device Regulators Forum (IMDRF). It’s a globally harmonized system that’s designed to increase patient safety and optimize care.
UDI system goals
Increase patient safety
- Improve tracing of devices
- Reduce the presence of counterfeit devices
Ensure access to accurate information
- Unambiguous identification of devices throughout distribution and use
Improve post-market surveillance
- Improve accessibility of adverse event reports
Enhance supply chain Management
- Streamline supply chain process and inventory management
- Simplify medical device documentation processes
The UDI system has four key elements
Element 1: Assignment of UDI (UDI Components)
The first element of the UDI system is the assignment of a UDI. The UDI is a code of alphanumeric characters that acts as the access key to information about a specific medical device on the market. The EU MDR and EU IVDR requires that a UDI be assigned to all medical devices except for custom-made or investigational devices. There are three components of a UDI:
- Basic UDI-DI
- UDI (consisting of UDI-DI and UDI-PI)
- Packaging UDI (Note: This is not an official term used in the EU MDR and IVDR, but we’re using it to help explain the concept. The Packing UDI is part of the UDI itself.)
1. Basic UDI-DI
The Basic UDI-DI identifies the device group that a particular device fits into. A device group is a group of products that all share the same intended purpose, risk class, essential design, and manufacturing characteristics. A device group is generally classified by medical device manufacturers as a “Product Family” or “Product Category,” depending on the internal nomenclature used within the company. The Basic UDI-DI functions as a parent or higher-level descriptor of a device.
NOTE: There can only be one Basic UDI-DI per UDI-DI.
The Basic UDI-DI is not printed on the product itself or on the packaging of a product, but rather it must be included in the following documents and applications:
- Certificates (Including Certificate of Free Sale)
- EU Declarations of Conformity
- Techical Documentation
- Summary of Safety and Clinical Performance
2. UDI (UDI-DI and UDI-PI)
The second component is the UDI itself, which consists of two parts:
Device Identifier (DI)
Production Identifier (PI)
The UDI-DI (Device Identifier DI, also referred to as “static”) identifies specific, detailed information about a particular device. If any of the below details should change, the device will need a new UDI-DI.
- Name or trade name of the device
- Device version or model
- If labelled as a single use device
- Packaged as sterile
- Maximum number of uses
- Need for sterilization before use
- Quantity of devices provided in a package
- Critical warnings or contra-indication
- CMR/endocrine disruptors
NOTE: There can be several UDI-DIs for one Basic UDI-DI.
Meanwhile, the UDI-PI (Production Identifier PI, also referred to as "dynamic") contains manufacturing information (including serial number, lot/batch number, software identification, and manufacturing or expiry date or both types of dates.)
To better illustrate this concept of Basic UDI-DI and UDI (UDI-DI and UDI-PI), let’s use a syringe as an example. The Basic UDI-DI would identify the category of a syringe, for example, "Enteral (Oral) Syringe."
A 5ml Enteral (Oral) Syringe – Sterile (Color: Purple) would get a unique UDI-DI and a 10m Enteral (Oral) Syringe – Sterile (Color: Orange) would get a unique UDI-DI. Both products would be associated to the same Basic UDI-DI. In this case, the "Enteral (Oral) Syringe," which defines the category.
Each time that 5ml Enteral (Oral) Syringe – Sterile (Color: Purple) is manufactured at the same revision, it will get a new UDI-PI per lot. See the graphic below.
Each product is identical and therefore has the same UDI-DI. However, the UDI-PI changes to reflect the manufacturing date, lot number, expiry date, and serial number, as applicable.
The UDI will contain all device-specific information and have the same functions as the comparable database (GUDID) of the United States FDA. The main difference (in EUDAMED) is that the UDI data is divided into components of Basic UDI-DI, UDI, and Packaging UDI.
3. Packaging UDI
The third component of UDI is the Packaging UDI. (Note: This is not an official term used in the EU MDR and IVDR, but we’re using it to help explain the concept.)
Each level of packaging, except shipping containers, must receive its own unique UDI. Packaging UDI refers to the unique UDI assigned to higher levels of packaging instead of the device itself.
In the event of significant space constraints on the unit of use packaging, the UDI Carrier may be placed on the next higher packaging level.
Returning to our earlier example of syringes, if a manufacturer first packages a single sellable syringe into an individual box, this package would receive its own UDI-DI and UDI-PI.
If then the manufacturer packages those individual boxes into containers of six (6), those containers would receive their own UDI-DI and UDI-PI.
And finally, if the manufacturer packages those six (6) containers into cases of four (4), those cases would receive their own UDI-DI and UDI-PI.
Each of those levels of packaging must be assigned its own UDI-DI and UDI-PI. The initial syringe did not change, but the way it is packaged did, therefore, requiring its own UDI-DI and UDI-PI.
Element 2: Placing UDI on the device and/or packaging
The second element to the UDI system is the placing of the UDI on the device or on its packaging through what is referred to as a “UDI Carrier.” The UDI Carrier is the part of the label that contains the UDI information that is applied directly to the device or included on the device packaging. The UDI Carrier should have both a machine-readable portion (AIDC) and a human-readable portion (HRI). (Specific details about each element of the UDI will be covered in Chapter 2.)
- Machine-readable form – AIDC – (Automatic Identification and Data Capture) is a barcode or other machine-readable technology that can be accessed automatically by scanning the UDI information.
- Human-readable form – HRI – (Human Readable Interpretation) is the numeric or alphanumeric code, which can be manually entered into the system for access to the UDI information.
If there are space constraints limiting the use of both the AIDC and HRI on the label, then only the AIDC is required to appear. However, on devices that are intended to be used in home-health care or other non-medical facility settings, the HRI would be required to appear.
Single-use devices may contain the UDI Carrier on its lowest level of packaging rather than on the device itself.
Reusable devices must include the UDI Carrier on the device itself, unless any type of direct marking would interfere with the safety or performance of the device, or if it is not technologically feasible to directly mark the device. If so, this should be properly documented in your design history file.
Most importantly, the UDI Carrier must be readable for the intended lifecycle of the device.
Below is an example of a GS1 AIDC and HRI barcode label.
Element 3: Storage of UDI information by Economic Operators
Storage of UDI information by "Economic Operators" is the third element of the UDI system. 2017/745 Articles 2(35), 22(1), and 22(3) define an economic operator as:
- A manufacturer
- An authorized representative
- A distributor
- An importer
- An investigator for clinical investigations
- A person who sterilizes systems or procedure packs
Class III, implantable device:
According to EU MDR 2017/745 Annex II, the manufacturer shall keep an updated list of all UDIs that it has assigned. Economic operators and all health institutions are required to store, preferably by electronic means, the UDI of all the devices for which they have supplied or with which they have been supplied.
For Devices Other than Class III:
Member States are encouraged, and in some cases require, health institutions to store, preferably by electronic means, the UDI of the devices with which they have been supplied. The UDI must also be included in any field safety notice for reporting serious incidents and field safety corrective actions.
The EU MDR and EU IVDR also give the European Commission authority to make additional requirements regarding the submission or maintenance of UDI information. In making those decisions, the European Commission must consider six (6) areas:
- Confidentiality and data protection
- Risk-based approach
- Cost-effectiveness of the additional measures
- The need to avoid duplications in the UDI system
- The needs of the healthcare systems of the member states
- Harmonization with other medical device identification systems
To continue reading this eBook including information about the EUDAMED database, UDI format requirements and issuing entities, implementation timelines, and key differences between the EU and US UDI systems, please register to download the full version
Arena Solutions and Rimsys announce partnership to offer an end-to-end quality and product-centric regulatory solution
Foster City, Calif., January 12, 2021 – Arena Solutions, a leader providing cloud-based product development solutions for high tech, consumer electronics, and medical device industries, today announced a new partnership with Rimsys Inc., a world-leading provider of a holistic Regulatory Information Management (RIM) software platform designed specifically for medical technology (medtech) companies.
The Arena and Rimsys partnership offers a secure cloud-based, product-centric regulatory solution for the medtech industry. Rimsys seamlessly integrates with Arena’s QMS and PLM solutions by pulling product and documentation information directly into Rimsys to create, manage, and maintain marketing applications such as 510(k), Summary Technical Documentation (STED), and Table of Contents (ToCs).
The Arena product development platform connects product and quality processes allowing dispersed teams throughout the product design and manufacturing process to work together. Rimsys integrates with Arena’s platform by syncing product information so companies can better manage global registrations and selling status at the SKU level. Rimsys has the capability to pull in QMS records and documentation to create and compile regulatory applications from approved documentation. The integration automatically monitors for documentation changes and alerts users when updates occur with additional reporting based on document location ensuring a single and accurate source of truth.
"The seamless and deep integration between Rimsys and Arena solutions reduces the day-to-day regulatory management," said James Gianoutsos, Founder and President of Rimsys. "The administrative burden of compiling marketing applications and the maintenance of product data is completely eliminated, allowing for increased compliance, efficiency, and visibility throughout the organization."
"Our partnership with Rimsys makes it easier for MedTech companies to address regulatory affairs, product registration, and standards management more effectively," said George Lewis, VP of Business Development and Strategy for Arena Solutions. "This new integration streamlines regulatory compliance processes by accelerating the notification of updates to critical quality records and documents."
About Arena Solutions
Arena Solutions helps innovative electronic high tech and medical device companies create products that change the world. Arena unifies product lifecycle (PLM) and quality management (QMS) processes, allowing every participant throughout the product realization process from design to manufacturing to work together. With Arena, teams accelerate product development and delivery to increase profits. For more information, visit ArenaSolutions.com.
About Rimsys
Rimsys is a world-leading provider of Regulatory Information Management (RIM) software for medical technology companies. Built by and for regulatory affairs professionals, Rimsys digitizes, automates, and creates regulatory order to ensure products adhere to changing global regulations. It is the only holistic RIM software for medical devices, in-vitro diagnostics, and medical device software that makes it easy to manage global UDI requirements and navigate the pillars of regulatory affairs, including product registration, standards management, essential principles/GSPR, and regulatory intelligence. rimsys.io
Rimsys releases new automated unique device identification (UDI) module for its holistic medtech RIM platform
Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced the release of an innovative and automated solution to address the global Unique Device Identification (UDI) requirements. This enhancement to the Rimsys ecosystem is immediately available to new and existing customers, providing a compliant method for tracking and traceability of UDI data that is fully compatible with global health authority databases.
UDI is a global harmonization effort to provide more consistent data that benefits overall product traceability throughout the medical device supply chain. It aims to adequately identify medical devices from manufacturing through distribution to patient use. Because global markets have different UDI requirements, product data can become a maintenance nightmare, even for the most mature medical technology companies. Data management is further complicated as UDI data is not static and must be updated based on changing regulatory requirements, such as market dates and registration status.
"Rimsys is the first automated UDI solution to fully integrate into a product’s registration lifecycle, ensuring that changing regulatory information is properly captured, registered, and maintained with the product and within government UDI databases like the GUDID (USA) and EUDAMED (EU)," said James Gianoutsos, Founder & President at Rimsys, "The current solutions landscape revolves around creating in-house, custom, and expensive projects with custom-built software or existing ERP software that were not designed to keep up with the fast-paced and ever-changing regulatory landscape."
In order to stay compliant and competitive, medical technology companies need to adapt quickly and flawlessly to the regulatory environment. As UDI requirements are rolled out across the globe, Rimsys’ UDI module seamlessly integrates with product registration data that is already actively managed within Rimsys, resulting in less maintenance, reduced costs, better compliance, and ultimately decreased time-to-market.
"We have already seen how our system has helped world-leading medical technology companies, such as Johnson & Johnson, Omron, and Terumo, digitize, automate, and navigate the global regulatory landscape,” said Brad Ryba, Chief Technology Officer at Rimsys, "As these requirements and demands continue to evolve, we are committed to ensuring that regulatory professionals can leverage the data integrations within Rimsys to more proactively manage their regulatory information."
Interested customers can schedule a preview of the new UDI module.
Rimsys named 2020 top technology company finalist by Tech 50 awards
Rimsys has been named a Finalist in Tech 50’s 2020 awards program hosted by the Pittsburgh Technology Council. The awards program, which was held November 12, 2020 at a virtual gala event, announced the winners and finalists. Rimsys was nominated as Innovator of the Year in the MedTech category, along with Sentact, Philips, and TeleTracking Technologies. In addition to the Company’s nomination, Rimsys’ Founder and CEO, James Gianoutsos, was nominated for CEO of the Year.
The awards program honors technology innovation in the region. Rimsys Inc., provider of the only holistic Regulatory Information Management (RIM) software for medtech is headquartered in Pittsburgh, Pennsylvania and was proud to be among the 2020 nominees. Rimsys was named a finalist this year, as Sentact, a provider of healthcare technology solutions for the patient care journey, walked away as the winner. Barbara VanKirk, CEO of IQ Inc., won this year’s CEO of the Year award.
"Rimsys is honored to be a finalist in both categories. Thank you to the Pittsburgh Technology Council for highlighting all of these innovative companies, and congratulations to this year’s winners," said Gianoutsos, "Rimsys is already used and trusted by leading companies, including Johnson & Johnson and Terumo, and we look forward to the near future where Rimsys’ automation of the global regulatory landscape is commonplace for medical technology companies and regulatory affairs professionals."
James Gianoutsos founded Rimsys in 2017, recognizing that while regulatory management platforms existed for pharmaceutical companies, medical technology companies face an entirely different set of challenges and requirements. Equipped with the expertise and drive to give regulatory affairs professionals a better way, he developed Rimsys: a RIM software built 100% for medtech companies.
Rimsys consolidates all the major functions of regulatory affairs on a 100% secure, cloud-based software, making product registration, standards management, essential principles/GSPR, and regulatory intelligence easy. Its newest integrated module manages global UDI requirements.
"It’s been an unparalleled year with unthinkable challenges," said Audrey Russo, President & CEO of the Pittsburgh Technology Council, "The COVID-19 Pandemic has tested everyone’s mettle in ways never imagined. This year’s Tech 50 is a testament to the fortitude, creativity, and innovation that exists across our industry, membership, and in every Tech 50 winner and finalist."
For a full list of finalists and winners, visit the Pittsburgh Technology Council’s website.
Rimsys secures $1.5 million to accelerate growth of its leading medtech regulatory information management platform
Rimsys Inc., provider of the leading Regulatory Information Management (“RIM”) software designed specifically for medical technology (“medtech”) companies, announced today it closed a $1.5 million investment round, led by Allos Ventures. The financing round will support Rimsys’ penetration of the medtech RIM market through planned expansions of its product offering, sales, and marketing execution. Rimsys serves an expanding list of enterprise customers, including industry leaders such as Johnson & Johnson and Terumo.
"Complex regulatory challenges create barriers that delay product time-to-market, stall revenue growth and increase exposure to compliance risks for even the most experienced medtech companies," said James Gianoutsos, founder & president of Rimsys. "Regulatory teams are in need of digital solutions that provide more efficient and compliant ways to stay on top of a constantly changing regulatory environment"
Rimsys’ solution seamlessly integrates with medtech manufacturers’ existing quality management systems, product lifecycle management systems, and sales and distribution software systems. Rimsys’ robust digital platform, with its intuitive user interface and global intelligence, enables its customers to meet market entrance requirements and grow internationally. John McIlwraith, managing director at Allos Ventures will join Rimsys’ board of directors.
"The maze of global regulations covering medical technology is growing more complex and frequently results in dead ends and delays that can greatly impact commercialization of these products," said McIlwraith. "This financing round will enable the company to further accelerate its momentum with large enterprise customers."
For more information on Rimsys, please visit www.rimsys.io.
Rimsys announces new brand identity for world-leading regulatory information management (RIM) software
Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced a new brand identity and tagline. Rimsys, the only holistic RIM software on the market designed specifically for medical technology companies, with functionality for the pillars of regulatory affairs, rebranded to accurately reflect its novel and advanced offering through a distinct, modern brand identity and messaging platform.
The new visual identity, including logo, color palette, graphic elements, and iconography mirror the trusted, relatable, and modern personality of Rimsys. The colors, which feature a vibrant purple and dark blue, were strategically chosen to differentiate Rimsys from other RIM solutions on the market. The visuals are accompanied by a new mission statement, “to digitize, automate, and create regulatory order for the medical technology industry,” and messaging platform that conveys its value propositions:
- Used and trusted by the world’s leading medtech companies
- Built by and for regulatory affairs professionals in medtech
- Easy to start and simple to scale as your company grows
"We’re pleased to announce this rebrand to our customers and partners, with complete confidence that the new identity and messaging accurately reflect our enterprise software solution," said James Gianoutsos, Founder & President at Rimsys.
Rimsys consolidates all the major functions of regulatory affairs on a 100% secure, cloud-based software, making product registration, standards management, essential principles/GSPR, and regulatory intelligence easy. These functions, plus soon-to-be-released features, were formally messaged in the rebrand, including superior server security, system compliance, and simple integrations with many leading enterprise QMS and ERP/PLM software systems.
"With successful implementations in some of the world’s leading medical technology companies including Johnson & Johnson and Terumo, we already know Rimsys has the power to modernize medtech companies of all sizes and scales," said Gianoutsos. "And now, with a brand that mirrors our capabilities, we’re even better poised to reach out and help more."
Components of the rebrand can be seen on rimsys.io, and the full rebrand will be revealed on a new website that is currently under development.
Announcing the release of Rimsys 3.0: Rimsys Insight
Rimsys Regulatory Management Software, the leading and only Regulatory Information Management (RIM) system platform designed specifically for the medtech industry, has just released Rimsys 3.0, which includes its much anticipated regulatory intelligence module, Rimsys Insight.
Rimsys 3.0 now offers curated regulatory news along with changes to laws, regulations, and guidances that are timely and linked to customers’ specific products, markets and the other customizable filters available to each company. Additionally, the integration of market entrance requirements for the top 50+ global markets, further strengthen the already powerful Rimsys Registrations workflow which manages medical device and IVD registrations at the SKU level.
"Information is meaningless unless you can apply context to it as it relates to your company and products. As regulatory professionals ourselves, we know the specific pain that is experienced by our customers. The user experience should be seamless, fully integrated, and intuitive enough that, regardless of how long that person has been in the industry"
Rimsys was built for and by regulatory affairs professionals, enabling teams to digitize and automate otherwise disjointed, paper-based and manual processes. Rimsys has spent the last year working with customers from some of the world’s leading medical device manufacturers to develop the requirements that seamlessly integrate their business processes with its existing ecosystem of cloud-based regulatory affairs software solutions. This includes global product registrations, submissions management, standards management, essential principles and more.
"There’s simply no other holistic and vertically integrated solution quite like Rimsys out in the marketplace. Our initial features were focused on bringing MedTech companies together to collaborate and connect with each other internally. Built on this solid foundation, our latest release truly empowers and connects them to the entire global regulatory ecosystem"
Rimsys is a holistic approach to modernizing, digitizing and automating regulatory affairs activities for the MedTech industry by providing a single source of truth. Rimsys is now aligned and positioned to continue its growth and mission to "digitize, automate and createregulatory order for the medical technology industry™."
