Updated: 24th June 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder & CEO)
What is Medical Device UDI?
Unique Device Identification (UDI) is a globally recognised system used to uniquely identify medical devices throughout their entire lifecycle. Rather than relying solely on product names or catalogue numbers, UDI provides a standardised method of identifying individual devices, improving traceability from manufacture through distribution, clinical use and post-market surveillance.
Today, UDI forms a key part of medical device regulations in many jurisdictions, including the European Union, the United States and an increasing number of international markets. Although implementation requirements vary between regions, the underlying objective remains the same: to ensure every medical device can be accurately identified throughout the supply chain, enabling manufacturers, healthcare providers and regulators to respond quickly if safety issues arise.
A UDI is made up of two primary components:
UDI-DI (Device Identifier)
The Device Identifier (UDI-DI) is the static portion of the UDI. It identifies the manufacturer and a specific version or model of a medical device. Unless the device itself changes in a way that requires a new identifier, the UDI-DI remains unchanged throughout the product’s lifecycle.
The UDI-DI is also used within regulatory documentation and device registration databases, allowing regulators to associate a particular device model with its technical documentation and manufacturer.
UDI-PI (Production Identifier)
The Production Identifier (UDI-PI) contains variable production information that enables individual devices or production batches to be distinguished from one another. Depending on the product, the UDI-PI may include:
- Batch or lot number
- Serial number
- Manufacturing date
- Expiry date
- Software identification (where applicable)
This production information supports effective inventory management, field safety corrective actions, product recalls and post-market surveillance by allowing manufacturers to identify precisely which devices are affected by a particular issue.
Together, the UDI-DI and UDI-PI provide a unique identity for each medical device, supporting accurate traceability throughout its lifecycle. This standardised approach improves communication between manufacturers, distributors, healthcare providers and regulatory authorities while helping to strengthen patient safety and regulatory oversight.
Note: Under the EU MDR, manufacturers will also encounter the Basic UDI-DI, which groups related devices for regulatory purposes and is used within technical documentation, certificates and regulatory submissions. This guide introduces the concept of UDI at a high level, while our dedicated guide to UDI types and identifiers explains the differences between the Basic UDI-DI, UDI-DI and UDI-PI in greater detail.
New to the EU MDR?
Unique Device Identification (UDI) is a key requirement under Regulation (EU) 2017/745, helping improve device traceability and patient safety. For a complete overview of MDR compliance, including classification, Article 10 obligations, GSPRs, technical documentation, EUDAMED and CE marking, explore our EU MDR for Beginners Guide.
Why Was the UDI System Introduced?
The Unique Device Identification (UDI) system was introduced to improve the traceability, transparency and safety of medical devices throughout their lifecycle. Historically, identifying affected devices during product recalls, safety notices or vigilance investigations could be challenging, particularly when manufacturers, distributors and healthcare providers used different product identifiers. UDI provides a globally recognised identification system that enables every medical device to be accurately identified and traced from manufacture to clinical use.
Rather than serving as a simple labelling requirement, UDI supports multiple aspects of medical device regulation and helps manufacturers, healthcare organisations and regulatory authorities manage devices more effectively throughout their commercial life.
Improving Patient Safety
One of the primary objectives of UDI is to improve patient safety. If a device is found to have a manufacturing defect, labelling error or other safety concern, manufacturers can identify the affected products quickly and accurately. This allows field safety corrective actions and product recalls to be targeted at the specific devices involved, reducing unnecessary disruption while helping to protect patients.
Strengthening Device Traceability
UDI creates a consistent method of identifying devices throughout the supply chain. Manufacturers, importers, distributors, hospitals and healthcare professionals can all reference the same identifier, making it easier to trace products from manufacture through to clinical use. Improved traceability also supports inventory management and helps organisations monitor the movement of medical devices more effectively.
Supporting Post-Market Surveillance and Vigilance
As manufacturers collect complaint data, adverse event reports and post-market surveillance information, UDI allows this evidence to be linked to specific device models and production batches. This improves trend analysis, supports root cause investigations and enables manufacturers to take appropriate corrective actions when necessary.
Improving Regulatory Oversight
Regulatory authorities use UDI information to identify devices placed on the market, monitor compliance and manage safety information more efficiently. Standardised device identification also improves communication between regulators, manufacturers and healthcare providers, helping ensure consistent information is available throughout the regulatory lifecycle.
Facilitating Global Market Access
Although UDI requirements differ between jurisdictions, many regulatory authorities have adopted similar identification principles. Implementing a robust UDI system helps manufacturers comply with multiple regulatory frameworks, simplifying international market access and reducing the complexity of managing different product identification systems for different regions.
Ultimately, UDI is about far more than adding a barcode to a product label. It provides the foundation for modern medical device traceability, supporting patient safety, regulatory compliance and effective lifecycle management while improving the availability of accurate device information throughout the global healthcare system.
How UDI Works Around the World
Although the principles of Unique Device Identification (UDI) are recognised internationally, each regulatory authority has implemented its own framework for assigning, labelling and registering medical devices. Manufacturers placing products on multiple markets must therefore understand not only the common principles of UDI but also the specific requirements of each jurisdiction.
Despite these regional differences, most UDI systems follow the same fundamental approach. Manufacturers assign a unique identifier to each device, incorporate that identifier into the product labelling, and submit key device information to a regulatory database. This enables regulators, healthcare providers and manufacturers to identify products consistently throughout their lifecycle while supporting traceability, post-market surveillance and patient safety.
The table below provides a high-level comparison of the major UDI systems currently used around the world.
| Region | Primary Regulation | UDI Database | Key Requirements |
|---|---|---|---|
| European Union | EU MDR 2017/745 & IVDR 2017/746 | EUDAMED | UDI required for most medical devices and IVDs. UDI-DI used within technical documentation and regulatory submissions. |
| United Kingdom | UK Medical Devices Regulations (future UK UDI framework) | MHRA systems (under development) | The UK is developing its own UDI framework as part of wider regulatory reform. Manufacturers should monitor MHRA guidance for implementation timelines. |
| United States | FDA UDI Rule (21 CFR Part 830) | GUDID | UDI required on most devices, with data submitted to the Global Unique Device Identification Database (GUDID). |
| Australia | Therapeutic Goods Administration (TGA) | Australian UDI Database (AusUDID) | Australia is implementing UDI requirements through a phased programme aligned with international standards. |
| China | National Medical Products Administration (NMPA) | China UDI Database | UDI implementation continues to expand across device classifications through phased implementation. |
| Saudi Arabia | Saudi Food & Drug Authority (SFDA) | Saudi-DI | Manufacturers supplying the Saudi market must comply with national UDI requirements and device registration obligations. |
| South Korea | Ministry of Food and Drug Safety (MFDS) | National UDI Database | UDI requirements apply across multiple device classes with phased implementation. |
While implementation timelines and registration processes vary, manufacturers supplying multiple markets benefit from establishing a single global UDI strategy wherever possible. Using harmonised internal procedures, robust document control and consistent product data helps reduce duplication of effort and supports compliance across different regulatory jurisdictions.
Before placing a device on a new market, manufacturers should always verify the latest national UDI requirements, as implementation dates, database functionality and submission requirements continue to evolve.
UDI Structure and Issuing Agencies
Medical device manufacturers are responsible for assigning a Unique Device Identifier (UDI) to their products before they are placed on the market. However, manufacturers do not create UDI formats themselves. Instead, they generate UDI codes using internationally recognised standards developed by authorised issuing agencies.
These issuing agencies provide standardised numbering systems that ensure every UDI is globally unique and can be recognised consistently by manufacturers, regulators, healthcare providers and supply chain partners. By using a common framework, devices can be accurately identified regardless of where they are manufactured or distributed.
Currently, the three most widely recognised UDI issuing agencies are:
GS1
GS1 is the most commonly used issuing agency worldwide and is recognised by regulators including the European Commission and the U.S. Food and Drug Administration (FDA). It uses the Global Trade Item Number (GTIN) as the basis for the UDI-DI and provides globally recognised standards for product identification, barcoding and supply chain management.
Many manufacturers choose GS1 because it is already widely used across multiple industries and integrates easily with existing logistics and inventory systems.
HIBCC (Health Industry Business Communications Council)
HIBCC primarily serves the healthcare sector and provides an alternative UDI structure based on alphanumeric identifiers. It is particularly popular among some North American medical device manufacturers and offers flexible coding structures suitable for a wide range of healthcare products.
ICCBBA (International Council for Commonality in Blood Banking Automation)
ICCBBA specialises in products derived from human blood, tissues, cells and organs. Its ISBT 128 standard is internationally recognised for products requiring highly specialised traceability and is commonly used within transfusion medicine and transplantation services.
Choosing an Issuing Agency
For most manufacturers, selecting an issuing agency is one of the first decisions made during UDI implementation. The choice is often influenced by the markets in which devices will be sold, customer requirements, existing business systems and long-term product portfolio management.
Once an issuing agency has been selected, manufacturers should apply the chosen standard consistently across their product range. Changing issuing agencies at a later date can introduce unnecessary complexity, requiring updates to product identifiers, labelling, regulatory submissions and internal systems.
Although each issuing agency uses a different coding structure, they all support the same fundamental objective: providing globally unique identifiers that improve medical device traceability, regulatory compliance and patient safety.
UDI Labelling Requirements
Once a Unique Device Identifier (UDI) has been assigned, manufacturers must ensure it is correctly applied to the device and its associated labelling. The exact requirements vary depending on the applicable regulations, device classification and whether the product is intended to be reusable, but the overall objective is the same: to ensure the device can be accurately identified throughout its lifecycle.
In most jurisdictions, the UDI must be presented in both a human-readable format and a machine-readable format. This allows healthcare professionals to read the identifier directly while also enabling barcode scanners and inventory management systems to capture the information quickly and accurately.
Human-Readable Information (HRI)
The human-readable portion of the UDI displays the identifier as plain text on the product label or packaging. This enables users to identify the device even if barcode scanning equipment is unavailable and provides an additional level of verification during distribution, storage and clinical use.
Machine-Readable Information (MRI)
The machine-readable portion of the UDI is typically presented as a barcode or two-dimensional (2D) DataMatrix symbol. These formats allow rapid electronic capture of UDI information by manufacturers, distributors, hospitals and regulatory authorities, supporting inventory management, traceability and post-market surveillance activities.
Where Should the UDI Appear?
Depending on the applicable regulatory requirements, the UDI may need to appear on:
- The device label.
- Each higher level of packaging.
- The device itself, where direct marking requirements apply.
- Product packaging intended for distribution.
- Accompanying documentation where required by the applicable regulations.
Manufacturers should ensure that the UDI remains legible and durable throughout the intended lifetime of the product. Printing methods, label materials and barcode quality should be selected to ensure the identifier can be reliably read during storage, transportation and normal use.
Direct Marking of Reusable Devices
Certain reusable medical devices that are intended to be reprocessed between uses may require the UDI to be permanently marked directly onto the device itself. This helps ensure the identifier remains available throughout the product’s usable life, even when external packaging has been discarded.
The method used for direct marking should be appropriate for the device and must not compromise its safety, performance or ability to be effectively cleaned, disinfected or sterilised where applicable.
Although UDI labelling requirements may differ slightly between regulatory jurisdictions, the underlying principles remain consistent. Manufacturers should ensure that their labelling processes, quality management system and document control procedures work together to maintain accurate, durable and compliant UDI information throughout the product lifecycle.
Want to Learn More About Medical Device Labelling?
Unique Device Identification (UDI) is only one element of compliant medical device labelling. Learn about the wider MDR labelling requirements, mandatory information, symbols, Instructions for Use (IFU) and best practices for creating compliant medical device labels.
Registering UDI Information with Regulatory Databases
Assigning a Unique Device Identifier (UDI) is only one part of the compliance process. In many jurisdictions, manufacturers must also register key information about their devices within a regulatory database before placing them on the market. These databases provide regulators with access to standardised product information, helping improve market oversight, device traceability and patient safety.
Although each regulatory authority operates its own database, the information submitted is generally based on the device’s UDI-DI and includes details such as the manufacturer, device description, risk classification and other regulatory information. Maintaining accurate and up-to-date records is essential, as inconsistencies between regulatory databases, product labelling and technical documentation may lead to compliance issues.
European Union – EUDAMED
Under the EU MDR and IVDR, manufacturers are required to submit UDI-related information to the European Database on Medical Devices (EUDAMED). As the European Commission continues to roll out the various EUDAMED modules, manufacturers should ensure that their device registration information is prepared and maintained in accordance with the applicable regulatory requirements.
In addition to supporting market surveillance, EUDAMED improves transparency by providing regulators and, where applicable, the public with access to important information about medical devices placed on the European market.
United States – GUDID
In the United States, manufacturers submit Device Identifier (UDI-DI) information to the Global Unique Device Identification Database (GUDID), which is managed by the U.S. Food and Drug Administration (FDA). GUDID contains key product information associated with each registered device and supports regulatory oversight, product traceability and public access to medical device information.
Other National Databases
Many other countries have introduced, or are developing, their own UDI registration systems. Although submission processes differ between jurisdictions, the underlying objective remains consistent: ensuring that regulators have access to reliable information about medical devices placed on their markets.
Manufacturers supplying devices internationally should establish procedures for managing regulatory database submissions alongside their wider UDI programme. Maintaining consistent product information across labelling, technical documentation and regulatory databases reduces the risk of discrepancies and supports efficient compliance across multiple markets.
As regulatory requirements continue to evolve, manufacturers should regularly review their device registrations to ensure they remain accurate following product changes, regulatory updates or revisions to the technical documentation.
How Do UDI and EUDAMED Work Together?
Assigning a Unique Device Identifier (UDI) is only part of the compliance process. Discover how UDI and EUDAMED work together to improve medical device traceability, support post-market surveillance, strengthen regulatory oversight and meet the requirements of Regulation (EU) 2017/745.
Common Challenges When Implementing UDI
Implementing a Unique Device Identification (UDI) system is far more than assigning a barcode to a product label. It often requires changes to labelling processes, internal procedures, regulatory documentation, enterprise systems and quality management processes. While the fundamental principles of UDI are straightforward, successful implementation requires careful planning and coordination across multiple departments.
Understanding the most common implementation challenges allows manufacturers to develop a more structured approach and avoid unnecessary delays or compliance issues.
Managing Large Product Portfolios
Manufacturers with extensive product ranges may need to generate and maintain hundreds or even thousands of unique device identifiers. Establishing a logical product hierarchy, maintaining accurate product data and ensuring each device is assigned the correct identifier can become increasingly complex as portfolios expand.
Developing a clear UDI strategy early in the implementation process helps minimise duplication and simplifies ongoing maintenance.
Maintaining Accurate Product Data
UDI relies on accurate and consistent product information. Device descriptions, product codes, classifications, packaging configurations and regulatory information should remain aligned across technical documentation, labelling, enterprise systems and regulatory databases.
Small inconsistencies between these records can create significant administrative challenges and may result in regulatory queries or delays during device registration.
Integrating UDI into Existing Business Systems
Many manufacturers discover that implementing UDI affects far more than their product labels. Enterprise Resource Planning (ERP) systems, Quality Management Systems (QMS), inventory management software, manufacturing systems and labelling platforms often need to be updated to support the creation, storage and management of UDI information.
Planning these integrations early helps reduce disruption and ensures UDI information remains consistent throughout the organisation.
Managing Product Changes
Medical devices continue to evolve throughout their commercial lifecycle. Design modifications, software updates, packaging changes and manufacturing improvements may all affect the assigned UDI or the information associated with it.
Manufacturers should establish formal change management procedures to assess whether product changes require updates to UDI records, regulatory database submissions or product labelling before modified devices are placed on the market.
Keeping Pace with Regulatory Developments
UDI requirements continue to evolve as regulatory authorities introduce new guidance, expand database functionality and refine implementation requirements. Manufacturers marketing products internationally should monitor regulatory developments in each jurisdiction to ensure their UDI programme remains compliant as new requirements are introduced.
Training Internal Teams
Successful UDI implementation relies on more than regulatory knowledge alone. Personnel involved in product development, manufacturing, quality assurance, regulatory affairs, purchasing, warehousing and distribution all play a role in maintaining accurate UDI information.
Providing appropriate training helps ensure employees understand their responsibilities and reduces the risk of errors affecting product identification or regulatory compliance.
Although implementing UDI requires an initial investment of time and resources, establishing robust processes from the outset significantly reduces the ongoing administrative burden. Manufacturers that integrate UDI into their existing quality management and change control systems are generally better positioned to maintain compliance, support international market access and respond efficiently to future regulatory developments.
Integrating UDI into Your Quality Management System
Successfully implementing Unique Device Identification (UDI) requires more than updating product labels or registering devices in regulatory databases. UDI should be integrated into the manufacturer’s Quality Management System (QMS) so that product identification remains accurate and consistent throughout the entire device lifecycle.
By embedding UDI into existing quality processes, manufacturers can ensure that changes to products, labelling and regulatory information are managed in a controlled and traceable manner. This not only supports regulatory compliance but also reduces the risk of inconsistencies developing between technical documentation, product labels and regulatory submissions.
Document Control
UDI information should be maintained under the manufacturer’s document control procedures. Product identifiers, labelling artwork and regulatory records should be subject to version control, formal review and approval processes to ensure only current information is used throughout the organisation.
Change Management
Whenever a design change, packaging modification, supplier change or manufacturing update is proposed, manufacturers should assess whether the change affects the assigned UDI or the associated regulatory information. Incorporating UDI into change management procedures helps ensure that product labels, technical documentation and regulatory databases remain aligned.
Technical Documentation
Whenever a design change, packaging modification, supplier change or manufacturing update is proposed, manufacturers should assess whether the change affects the assigned UDI or the associated regulatory information. Incorporating UDI into change management procedures helps ensure that product labels, technical documentation and regulatory databases remain aligned.
Training and Responsibilities
Personnel involved in regulatory affairs, quality assurance, manufacturing, production planning and labelling should understand how UDI is generated, maintained and applied within the organisation. Clearly defining responsibilities helps reduce the risk of incorrect product identification and supports consistent implementation across multiple departments.
Periodic Reviews
UDI should form part of routine quality management reviews. Periodically verifying product identifiers, label artwork, regulatory database submissions and supporting documentation helps identify discrepancies before they become compliance issues and ensures the UDI system continues to support effective traceability throughout the product lifecycle.
By integrating UDI into everyday quality management activities, manufacturers move beyond treating it as a standalone regulatory requirement. Instead, UDI becomes part of a wider compliance framework that supports product traceability, effective change management and continual regulatory compliance throughout the life of the medical device.
UDI Starts with a Strong Quality Management System
Document control, change management and traceability are all fundamental principles of ISO 13485. Learn how a compliant Quality Management System supports successful UDI implementation and ongoing regulatory compliance.
How to Get Started with UDI Implementation
Implementing a Unique Device Identification (UDI) system may seem complex, particularly for manufacturers introducing UDI for the first time or supplying products across multiple regulatory jurisdictions. Breaking the process into manageable steps allows organisations to develop a structured implementation programme while ensuring regulatory requirements are addressed systematically.
The following roadmap provides a practical approach to implementing UDI within your organisation.
Step 1: Confirm Whether UDI Applies to Your Devices
Begin by determining which of your medical devices or IVDs are subject to UDI requirements in the markets where they will be placed on the market. Regulatory obligations may differ depending on the jurisdiction, device classification and any applicable exemptions, making it important to understand the specific requirements before implementation begins.
Step 2: Select an Appropriate Issuing Agency
Choose an issuing agency that supports your business requirements and the markets in which your products will be sold. Most manufacturers select a single issuing agency and apply its standards consistently across their entire product portfolio to simplify long-term management.
Step 3: Assign Device Identifiers
Generate the appropriate UDI identifiers for each product in accordance with the chosen issuing agency’s rules. Manufacturers should establish internal procedures to ensure identifiers are assigned consistently and maintained throughout the product lifecycle.
Step 4: Update Product Labelling
Revise product labels, packaging and, where applicable, direct markings to incorporate the required human-readable and machine-readable UDI information. Before release, manufacturers should verify that barcode quality, readability and label durability meet the applicable regulatory requirements.
Step 5: Register Device Information
Submit the required UDI information to the relevant regulatory database for each market in which the device will be supplied. Manufacturers should verify that information submitted to regulatory databases remains consistent with product labelling, technical documentation and internal product records.
Step 6: Update Internal Procedures
UDI should be incorporated into the organisation’s quality management processes, including document control, change management, product registration, labelling, training and post-market surveillance. Clearly documented procedures help ensure UDI information remains accurate as products evolve.
Step 7: Maintain and Review Your UDI System
UDI implementation does not end once devices have been placed on the market. Manufacturers should periodically review product identifiers, regulatory registrations and supporting documentation to ensure information remains accurate following design changes, manufacturing updates, regulatory developments or other lifecycle changes.
By following a structured implementation programme, manufacturers can establish a UDI system that not only satisfies regulatory requirements but also strengthens product traceability, improves operational efficiency and supports ongoing compliance throughout the medical device lifecycle.
UDI Starts with Well-Structured Technical Documentation
Unique Device Identification (UDI) is closely linked to your MDR technical documentation. Learn how to structure a medical device technical file in accordance with Annexes II and III of Regulation (EU) 2017/745, including device description, GSPRs, risk management, clinical evaluation, verification and validation, and post-market surveillance.
Read our guide to structuring a medical device technical file →
How Patient Guard Can Help
Implementing a compliant Unique Device Identification (UDI) system requires careful planning, accurate product data and a clear understanding of the regulatory requirements in each market where your devices are supplied. Whether you are introducing UDI for the first time or reviewing an existing programme, Patient Guard provides practical regulatory support to help manufacturers implement and maintain effective UDI systems.
Our regulatory consultants work alongside manufacturers to ensure UDI requirements are integrated into wider regulatory and quality management processes, supporting efficient implementation while reducing the risk of compliance issues.
Our UDI support services include:
- UDI implementation planning for EU MDR, IVDR and international markets
- Advice on selecting an appropriate UDI issuing agency
- UDI strategy development for single products and large product portfolios
- UDI-DI and Basic UDI-DI implementation support
- Review of UDI labelling and regulatory documentation
- EUDAMED and GUDID registration support
- Technical documentation and UDI traceability reviews
- Integration of UDI into Quality Management Systems (QMS)
- Ongoing regulatory support following product or regulatory changes
Whether you’re preparing a new product for market, expanding internationally or updating an existing UDI programme, Patient Guard can help you establish a practical, compliant and sustainable approach to Unique Device Identification throughout the medical device lifecycle.
Frequently Asked Questions About UDI
UDI stands for Unique Device Identification. It is a globally recognised system used to uniquely identify medical devices throughout their lifecycle. A UDI improves traceability by providing standardised product identification that supports regulatory compliance, post-market surveillance and patient safety.
Yes. Under Regulation (EU) 2017/745 (EU MDR), most medical devices are required to have a Unique Device Identifier before being placed on the European market. Manufacturers must assign the appropriate UDI, incorporate it into product labelling and meet the applicable registration requirements.
The UDI-DI (Device Identifier) identifies the manufacturer and a specific device model, while the UDI-PI (Production Identifier) contains variable production information such as the batch number, serial number, manufacturing date or expiry date. Together they provide a complete identification system for each medical device.
The Basic UDI-DI is a regulatory identifier used under the EU MDR to group related medical devices with the same intended purpose, risk class and essential design characteristics. Unlike the UDI-DI, it does not normally appear on the product label but is used within technical documentation, certificates and regulatory submissions.
Most manufacturers select an issuing agency based on the markets in which they sell their products and their existing business systems. The three recognised issuing agencies are GS1, HIBCC and ICCBBA, each providing internationally accepted standards for generating Unique Device Identifiers.
Most medical devices supplied under the EU MDR and many other regulatory frameworks require a UDI. However, certain exemptions may apply depending on the applicable legislation, device type and intended purpose. Manufacturers should always verify the specific requirements for each jurisdiction in which their products are marketed.
Potentially. Certain design, manufacturing or regulatory changes may require a new Device Identifier or updates to associated regulatory records. Manufacturers should assess the impact of every significant product change through their change management process to determine whether UDI updates are necessary.
UDI enables manufacturers to identify affected devices quickly and accurately during product recalls or Field Safety Corrective Actions (FSCAs). Because each device can be traced through its assigned identifiers, corrective actions can often be targeted at specific production batches or device models rather than entire product ranges.
UDI allows complaints, adverse events and post-market surveillance data to be linked directly to specific medical devices and production batches. This improves trend analysis, supports root cause investigations and enables manufacturers to respond more effectively to emerging safety issues throughout the product lifecycle.
Yes. Patient Guard provides practical support for manufacturers implementing UDI under the EU MDR, IVDR and other international regulatory frameworks. Our consultants can assist with UDI strategy, issuing agency selection, labelling reviews, regulatory database submissions, technical documentation updates and integrating UDI into your Quality Management System.
References
This guide is based on the following legislation and official regulatory guidance relating to the Unique Device Identification (UDI) system under Regulation (EU) 2017/745 (MDR).
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Establishes the legal framework for the Unique Device Identification (UDI) system, including the requirements set out in Chapter III and Annex VI governing device identification, labelling and traceability. |
| European Commission | Unique Device Identifier (UDI) | Provides the European Commission's official overview of the UDI system, explaining its purpose, structure, benefits and role in improving medical device traceability and patient safety. |
| European Commission | UDI/Device Registration in EUDAMED | Explains how manufacturers register UDI and device information within EUDAMED and outlines the regulatory requirements for UDI/device registration under the MDR. |
| Medical Device Coordination Group (MDCG) | MDCG 2018-1 Rev.4 – Guidance on Basic UDI-DI and Changes to UDI-DI | Provides official guidance on the Basic UDI-DI concept, its use within technical documentation and certificates, and the circumstances that require a new UDI-DI to be assigned. |
| International Organization for Standardization (ISO) | ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes | Defines the internationally recognised Quality Management System requirements supporting device identification, labelling, document control and traceability throughout the medical device lifecycle. |
UDI requirements, EUDAMED functionality and regulatory guidance continue to evolve. Manufacturers should always consult the latest published legislation and official guidance when implementing and maintaining compliant Unique Device Identification systems under the MDR.
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