The unique device identifier (UDI) aka the barcode for EU medical devices. Do you need one?

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What is a UDI? 

The Unique Device Identifier (UDI) system is used for the global identification and tracing of medical devices throughout their lifecycle. Think of a UDI as a barcode - each UDI is a unique assembly of letters and numbers that adhere to a universally recognized standard used to identify your device. This identifier ensures your medical device can be distinctly recognized worldwide. 

The UDI system applies to all medical device classes and is composed of three components: the Basic UDI-DI, UDI-DI, and UDI-PI. 

  • Basic UDI-DI - Think of this as the identifier of your device family where it serves as the basic root identifier for your medical device products of the same purpose and family. This number can also be used to connect your device to all paperwork and records in healthcare databases related to devices that have the same intended use, risk class, and design.
  • The UDI-DI (Device Identifier) provides specific identification of device models within your device family and it remains consistent across different units of the same model. 
  • The UDI-PI (Production Identifier) varies with each production (or software version) and can include details like the manufacturing date and serial number, useful for tracking the device’s production specifics.

You will use the Basic UDI on technical documentation like your SSCP and Technical File. The Basic UDI-DI is also used as the access key for device-related information entered in the EUDAMED database, which is an EU-wide database for tracking medical devices on the market. You could see how this helps maintain a consistent record of your device across all regulatory databases and health records.

What are UDIs Used For?

The purpose of the UDI system is to ensure patient safety and optimize patient care through improved traceability and monitoring of medical devices. Let’s say something goes wrong with your device and you want to know which exact model is having issues - thankfully you have a UDI people can report back to you with. This feedback loop is crucial for safety events like field safety corrections and serious adverse events.

By implementing a UDI, devices can be tracked from production through distribution, use, and eventually removal of the device from the market. The system also helps reduce medical errors by ensuring that the right devices are used correctly in medical settings, combatting the use of falsified or improper devices. 

When Should You Get Your UDI? 

The responsibility of ensuring that the UDI is on the device packaging falls to you, the manufacturer, so a UDI must be obtained before your product is physically produced or your software is released. For this reason, obtaining and registering a UDI on the EUDAMED database is recommended to occur towards the end of the product development process. 

Who Can Issue a UDI? 

Currently, the European Commission (EC) has designated four (4) agencies for issuing UDIs. Each issuing agency has a slightly different process, naming and categorization system, and fee structure. The currently approved issuing agencies in the EU are:

  • GS1 is most commonly used by medical device manufacturers but also covers standards for retail, logistics, and tech. Their fee structure includes an initial and annual fee and depends on the country your company is based in, which you can check on their website
  • Health Industry Business Communications Council (HIBCC) focuses on the healthcare industry and charges a one-time fee when you sign up for your LIC code, which is specific to your organization. The fee is based on your previous year’s annual sales. They do not charge for your UDI after that. You can see the fee schedule here
  • International Council for Commonality in Blood Banking Automation (ICCBBA) is for medical products that contain human cells, tissues, and cellular and tissue-based products. Vendors are exempt from paying the registration fee but they charge a one-time and annual fee based on the type of facility, which you can see here
  • Informationsstelle für Arzneispezialitäten (IFA) GmbH covers pharmaceutical products and pharmacy-typical medical devices. Their fee structure is complicated with many different types of fees during different stages of certification and production but the fees are very low, most of them are below 100 euro. 

Choosing an agency is largely related to the intended use of your device. You can be assured that most devices MDR devices will use GS1 or HIBCC. For other products like in-vitro diagnostic devices and pharmaceutical products, look into the ICCBBA and IFAe. 

Labeling Requirements 

The guidelines for UDI of medical devices require that the UDI must be displayed on the device label or the device itself and on all higher packaging levels, excluding shipping containers. The label “carrier” must appear in both Automatic Identification and Data Capture (AIDC) and Human Readable Interpretation (HRI) formats. This means that the UDI should be present on the following packaging levels:

  • Primary packaging - the first layer that directly encloses the medical device. It's often designed to maintain the sterility or integrity of the product (e.g., syringe in a sterile pouch).
  • Secondary packaging  - holds one or several primary packaged products. It provides additional protection and often carries important labeling information necessary for handling and safety (e.g., a box containing multiple sterile pouches).
  • Tertiary packaging - used for bulk handling, such as large boxes or crates that contain several secondary packages, making it easier to transport large quantities of the product or sell it in bulk. 

An example of primary, secondary and tertiary packaging (image reference [1])

For a standalone software product, there is obviously not the same kind of place for a label as there is for physical products with packaging. As such, regulators prefer the device label and UDI be present somewhere within the software that is accessible for the users like the setting page or an “About” page. 

In situations with space so limited that a legible label isn’t feasible to put on the device, the UDI can be placed on higher packaging levels. Alsol, for certain single-use, low-risk devices, it is only required on the higher packaging unless used in settings like home healthcare. 

The idea behind this stems from the need to ensure that essential information about the medical device is accessible at each stage of the supply chain. For instance, a hospital receiving a shipment of devices might only interact with the tertiary packaging initially, so it's crucial that this level contains adequate labeling. Conversely, in a home healthcare setting, a medical professional may only have access to the primary packaging, so products used for home healthcare must have labelling on primary packaging or on the device itself. 

For reusable devices, the UDI should be permanent and readable post-reprocessing (if needed). Visibility of the UDI through the device package negates the need for additional labeling, ensuring that UDI accessibility supports normal use and storage efficiency.

For more specific information on labelling requirements, visit the EUMED help desk

What does a UDI actually look like?

As mentioned above, the UDI is just a combination of numbers and letters that are unique to your device. When you approach an issuing agency for a UDI, they will give you a company prefix and you will generate your Basic UDI-DI, UDI-DI, and even UDI-PI from that number. An example of a UDI-DI and UDI-PI with the AIDC and HRI formats can be seen in the image below.

Example image of a UDI-DI (image reference [2])

You can see in the above image the UDI-DI is static and identifies the device model while the UDI-PI shows different product information like manufacturing dates and serial numbers. As these UDI-DI and UDI-PI numbers are created for different models, versions, or variants of the medical device, they will all link back to the same Basic UDI-DI.

What Information is Needed for the EUDAMED UDI Database?

The data that you will need to collect for the UDI database includes information about your device from manufacturing details to usage instructions. The UDI database, part of the EUDAMED system, is designed to provide the public and healthcare professionals with access to information about the usage, indications, and other details of medical devices and to improve coordination among EU Member States. You will need to register your device in EUDAMED as part of the certification process. Simply log on to the EUDAMED website to register your device under your company profile that you create.

Requirements for registering your UDI are dependent on the EUDAMED module rollout. Currently it is required for Class IIa, IIb, III products and implantables and will be required for Class I products sometime in 2025. 

Rules for Specific Device Types

Due to the nature of the UDI, there are special requirements for certain device types. For example, knowing where to put a UDI for software without physical parts and knowing if a new version release affects the UDI-PI are important questions to ask yourself. Below is a table outlining some special rules for using a UDI based on the type of device.

Device Type Special UDI Rules
Software as a Medical Device (SaMD) The UDI should be assigned at the system level with the version number included. Major software updates necessitate a new UDI-DI, while minor ones might only need a new UDI-PI, and the UDI should be visible on an accessible screen or available through an API.
Configurable Medical Devices A system UDI covers the entire device system, with individual UDIs for each medical device component; significant changes to components may require a new system UDI.
IVD Kits Each component within the kit must have a UDI unless it's a non-device like certain reagents; the kit's UDI should be on the packaging and easily scannable.
Non-IVD Kits The kit must have a UDI on its packaging or directly on the device, ensuring external readability; single-use items within the kit typically do not need individual UDIs unless repackaged for separate use.
Reusable Devices Requiring Reprocessing UDIs must be directly marked on the device, enduring through reprocessing cycles. If direct marking impacts device safety or performance, it may be exempt.
Implantable Devices Every pack must have a UDI, with active devices requiring a serial number. Direct marking on the device itself isn't mandatory but the UDI must be scannable before implantation.

Time and Cost for a UDI

The cost associated with the UDI system comes from a few components:

  1. Data gathering for the EUDAMED Database registration
  2. UDI issuer fees depend on the size of your company, annual sales, and the type of device (see associated fees above, ranging from about 100 euro per year to a 20,000 euro one-time fee for a company with 500 million in annual sales)
  3. Printing and labelling devices at all packaging levels

Once you have gathered everything you need for your issuer application, which is just basic device information, you can expect approval rather quickly, barring any problem with your application. Once you have obtained your UDI from an issuing agency, you have to implement it, print and label all products, and submit it to EUDAMED. Putting together all of the safety, manufacturing, and clinical data and ensuring compliance is time-consuming, so we suggest you collect this information as you go. 

What Changes to the Medical Device Would Require a New UDI-DI?

If you make any significant changes to your device, packaging, product name, warnings, or usage recommendations, you would have to obtain a new UDI. While some changes only require a new UDI-PI, changes that could lead to possible misidentification or misuse of the device necessitate a new UDI-DI. Changing the following may require changes to your UDI-DI or UDI-PI:

  • Device version or modelsome text
    • For software, a UDI-DI is assigned at the system level, whereas a UDI-PI is assigned at the version level. Therefore, minor updates to a software version only require a new UDI-PI while major updates that change performance or safety may require a new UDI-DI.
  • Clinical Size (including Volume, Length, Gauge, Diameter)
  • Labeled as single-use
  • Packaged sterile
  • Need for sterilization before use
  • Quantity of devices provided in a packagesome text
    • This is an example of a change that would only necessitate a new UDI-PI. 
  • Critical warnings or contraindications: e.g. containing latex or DEHP. some text
    • This is an example of a change that would require a new UDI-DI.

If you make any changes to the device or usage instructions that do not necessitate a new UDI-DI, you must make these changes to the database within 30 days. A change large enough to warrant a new UDI-DI would require contacting your issuing agency.

Conclusion and Tips

The UDI system is an important and required tool for ensuring traceability and accountability of medical devices from manufacturing to market and beyond. Having a barcode by which to identify your medical device and ensure traceability in the marketplace is important. Creating your UDI is as simple as acquiring one from an issuing entity and generating appropriate UDI-DI and UDI-PI numbers for your product models and packaging.

By assigning a unique identifier to each device type, branded device, and individual product, you can effectively track your product performance, manage recalls more efficiently, and ensure continued patient safety. In this regard, obtaining and maintaining a UDI is essential not only for compliance but also for effective post-market surveillance. 

The UDI allows for accurate tracking of your device for both the device type and individually produced device. By integrating the UDI system, manufacturers can ensure that they are prepared to swiftly address potential device issues through targeted recalls and timely corrective actions. 

Actionable Tips:

  1. Timely application: Manufacturers should obtain a UDI towards the end of the product development process, ensuring it is on the device packaging before production begins.
  2. Check the fee schedule before choosing an issuing agency: Select an issuing agency that aligns with the device’s intended use and your expected trajectory for your product or company, so you can choose the fee schedule that makes the most financial sense. For most medical devices, GS1 or HIBCC would be suitable.
  3. Ensure compliance with labeling requirements: Ensure that the UDI is displayed on the device label and all higher packaging levels in both AIDC and HRI formats. For reusable devices, ensure the UDI remains readable post-reprocessing.
  4. Monitor changes and update the database: Any significant changes to the device, like modifications to the device version, clinical size, or critical warnings, necessitate a new UDI-DI. Ensure these changes are updated in the UDI database within 30 days.
  5. Update UDI-PI with each minor software version release: The UDI-PI should be updated to reflect new changes in the product through minor software version updates. Remember that changing your UDI-PI doesn’t require a new request from an issuing body and can be changed with the appropriate product information like the release date. 

FormlyAI: Your Partner in Medical Device Certification

At FormlyAI, we understand the complexities of MDR medical device certification. Our service provides a streamlined, efficient path to CE marking and all the tools to ensure your medical device adheres to all necessary EU regulations. All for a fraction of the cost of using traditional consultants. This way you can build your compliance documentation and apply for CE marking in a matter of weeks, not years.  

Learn more about our software and accelerate your path to CE marking with Formly.

Frequently Asked Questions

What is a Universal Device Identifier (UDI) and why is it required for medical devices in the EU?

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A UDI is a unique sequence of characters that identifies a medical device through its distribution and use. It's required in the EU to enhance traceability, improve patient safety, and streamline the management of medical device recalls.

How do I obtain a UDI for my medical device in the EU?

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To obtain a UDI, you must apply through an issuing agency recognized by the EU, such as GS1, HIBCC, or ICCBBA. These agencies provide the UDI, which must then be registered and listed in the EUDAMED database before the product goes to market.

How does UDI compliance differ for Class I versus Class IIa, Class IIb, and III devices?

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Class I devices typically have less stringent UDI requirements and often only need labeling on higher packaging levels unless used directly in home healthcare settings. Class IIa, IIb, and III devices require a UDI on all packaging levels and direct marking on the device itself if it is intended to be used more than once and reprocessed before each use.

How do UDI requirements in the EU compare with those in the US and other regions?

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UDI requirements are broadly similar in the EU and the US, focusing on ensuring device traceability and safety. However, the EU integrates UDI data within the EUDAMED database to facilitate broader access to device information and coordination among Member States, whereas the US uses the GUDID (Global Unique Device Identification Database) and has its own specific timelines and exceptions. Other regions may have their own unique requirements and timelines for implementation.

How do Basic UDI-DI, UDI-DI and UDI-PI differ?

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Your Basic UDI-DI will serve as the core identifier for your family of medical devices. For each model within the family, you will have a UDI-DI. If you only have one model, you will only have one UDI-DI. The UDI-PI provides additional information regarding that particular production version of the model that is on the market. This can include the serial number, lot number, version number, expiration date, or batch number. All three UDIs work together to assist in identifying your device on the market and tracking the performance and safety of the device on the market following its release.

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