What Is Unique Device Identification (UDI)?

The unique device identification system is a framework for labeling medical devices with a specific identifier, the UDI, which enables accurate tracking and data collection throughout the device’s lifecycle. A UDI consists of two parts:

1. Device Identifier (DI): Identifies the specific version or model of the device.
2. Production Identifier (PI): Contains variable information related to production, such as lot number, expiration date, and serial number.

This identifier, displayed on device labels in human- and machine-readable forms, allows regulatory bodies, manufacturers, and healthcare providers to track medical devices for improved patient safety, easier recalls, and more efficient inventory management.

Why Global UDI Implementation Matters

Given the international reach of many medical device companies, understanding the nuances of UDI requirements across different regions is essential. Non-compliance with UDI regulations in any given market can restrict a manufacturer’s ability to sell products in that area, which can have significant financial and operational repercussions. With each region implementing its UDI regulations in unique ways, manufacturers must adopt a tailored approach to meet compliance in each market.

UDI Implementation in Key Regions

The global adoption of the UDI system is led by major regulatory bodies, each with its own requirements and compliance timelines. Let’s explore the key differences in UDI regulations across regions.

1. United States: FDA UDI Requirements

The Food and Drug Administration (FDA) was the first major regulatory body to mandate the UDI system, introducing requirements in 2013 for medical devices sold in the United States. The FDA’s UDI rule applies to most devices and emphasizes patient safety through accurate device tracking. Key requirements include:

• Labeling Requirements: All UDI labels must contain both human-readable and machine-readable information, typically as a barcode.
• Global Unique Device Identification Database (GUDID): Manufacturers must submit UDI information to the FDA’s GUDID database, which stores critical device information accessible by healthcare providers and the public.
• Class-Based Compliance Timelines: The FDA rolled out UDI requirements in phases based on device risk class, with high-risk (Class III) devices required to comply first, followed by moderate-risk (Class II) and low-risk (Class I) devices.

The FDA’s phased approach emphasizes patient safety and helps manufacturers adapt their production and labeling systems. Non-compliance can result in penalties, market access restrictions, or delays in FDA approval.

2. European Union: MDR and EUDAMED Database

The European Union’s approach to UDI is outlined in the Medical Device Regulation (MDR), which replaced the previous Medical Device Directive (MDD) and introduced strict UDI requirements for devices marketed in the EU. The EU’s UDI framework shares some similarities with the FDA’s but has unique elements:

• Labeling and Data Submission Requirements: Like the FDA, the EU requires UDI labels to be human- and machine-readable. However, the EU mandates that UDI data be submitted to the European Database on Medical Devices (EUDAMED).
• Direct Marking Requirements: For certain reusable devices that must undergo sterilization, the EU requires direct marking of the UDI on the device itself.
• Device Classifications and Timelines: The EU’s MDR categorizes devices by risk, with higher-risk devices required to comply first. Although implementation has been delayed, compliance deadlines for MDR UDI requirements are approaching quickly, especially for Class I and II devices.

The EUDAMED database is central to the EU’s approach, allowing regulatory bodies across the EU to access accurate, updated device data. EUDAMED is not yet fully operational, but manufacturers must prepare for its eventual activation to ensure compliance.

3. Japan: UDI under PMDA Guidance

Japan, known for its rigorous medical device regulations, follows UDI requirements set by the Pharmaceuticals and Medical Devices Agency (PMDA). Japan’s UDI system, while similar in purpose to those in the U.S. and EU, has distinct features:

• Local Language Requirements: All UDI information must be displayed in Japanese, ensuring that healthcare providers can accurately read and interpret the labels.
• Japan Medical Device Nomenclature (JMDN): Japan mandates that devices include a JMDN code, a unique identifier specific to the Japanese regulatory framework, alongside the UDI.
• No Centralized Database Requirement: Unlike the FDA’s GUDID or the EU’s EUDAMED, Japan does not currently require submission of UDI data to a centralized database.

Manufacturers aiming to enter the Japanese market must prepare device labeling in Japanese and adapt to the local nomenclature requirements for successful UDI compliance.

4. China: NMPA UDI Regulations

China’s National Medical Products Administration (NMPA) has established its UDI system to improve device tracking and safety. China’s approach closely mirrors the FDA’s but has unique aspects tailored to the local market:

• China UDI Database: The NMPA requires that device information be submitted to a Chinese UDI database for regulatory oversight and tracking.
• Device Labeling in Chinese: All UDI information must be presented in Chinese, following NMPA guidelines to ensure local healthcare providers can read and verify device information.
• Phased Implementation: Similar to the FDA, China’s UDI requirements are phased in according to device risk class, prioritizing higher-risk devices for early compliance.

For manufacturers, navigating China’s regulatory landscape involves understanding local language requirements and ensuring compliance with the NMPA’s phased UDI timelines.

5. Other Regions: Australia, Brazil, and Canada

Several other countries have also begun implementing UDI frameworks, each with its own requirements:

• Australia: Australia’s Therapeutic Goods Administration (TGA) has been working to align its UDI requirements with international standards, though full implementation is still in progress.
• Brazil: The Brazilian Health Regulatory Agency (ANVISA) has signaled interest in UDI requirements, likely influenced by other major markets, though Brazil’s UDI system remains in development.
• Canada: Health Canada has been considering UDI implementation, looking to align its standards with those of the FDA and EU to facilitate market access and enhance patient safety.

As UDI requirements become standardized across these regions, global manufacturers must stay updated on changing regulations to avoid compliance issues and market entry delays.

Key Differences in Global UDI Requirements

To summarize, here are the primary differences in UDI requirements across regions:

1. Labeling Language and Format
   • U.S. and EU requirements are similar, using human- and machine-readable formats, while Japan and China mandate labels in local languages.
2. Centralized Databases
   • The U.S. (GUDID) and EU (EUDAMED) require UDI data submission to centralized databases. Japan and China have varying database requirements, with Japan not mandating a database submission.
3. Direct Marking Requirements
   • Direct marking on devices is required by the EU for reusable and sterilizable devices, while U.S. requirements may vary depending on device class and reusability.
4. Implementation Timelines by Device Class
   • Phased timelines for high-, moderate-, and low-risk devices vary across regions, requiring manufacturers to tailor compliance plans for each market.

Challenges and Solutions for Global UDI Compliance

For manufacturers, implementing UDI across multiple regions presents several challenges:

• Resource-Intensive Labeling and Translation Needs: Different language and labeling requirements necessitate significant investment in translation and labeling infrastructure.
• Varied Database Submissions: With each region’s unique database requirements, managing UDI data submissions can be complex and time-consuming.
• Ongoing Regulatory Updates: UDI regulations are evolving, and staying updated on new standards is essential for maintaining compliance.

To address these challenges, companies can:

• Invest in centralized data management systems that can be customized for regional requirements.
• Work with regulatory consultants to navigate UDI nuances across different markets.
• Use automated labeling and translation solutions to streamline UDI data preparation and ensure regulatory compliance.

Conclusion

The global implementation of unique device identification varies significantly across regions, with each regulatory body enforcing its own requirements and timelines. For medical device manufacturers, understanding and adhering to these regional UDI regulations is critical to ensure market access, enhance patient safety, and support device traceability. By developing tailored strategies for each market and investing in advanced data management systems, manufacturers can successfully navigate the complexities of global UDI compliance. Staying ahead in this dynamic regulatory landscape not only helps companies maintain compliance but also builds a reputation for quality, safety, and reliability in healthcare markets worldwide.

Legacy devices that will be registered in EUDAMED will need two other unique access keys (IDs) to replace the Basic UDI-DI and UDI-DI for the sake of the workability of EUDAMED.

For this purpose, a EUDAMED DI will be assigned to the device instead of the Basic UDI-DI and a EUDAMED ID will be assigned by EUDAMED instead of the UDI-DI allowing the system to work and to keep the design of EUDAMED as close as possible to the MDR design. These EUDAMED DI and EUDAMED ID will be unique for a given legacy device.

Requirements to Register a Legacy device in UDI Module

Once this informationis entered in module, click on “Submit” to submit it directly or “Preview” to view before submitting: A pop-up window will appear asking you to confirm your submission. Once you confirm, you will be brought to a new window confirming the submission of your Legacy device.

Timeline for Submission

Currently, legacy devices should be understood as devices and are placed on the market after the MDR’s date of application -26 May 2021- and until 26 May 2024 if:

• They are class I devices, for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body.
• They are devices covered by a valid EC certificate issued prior to 26 May 2021.

The registration of legacy devices in EUDAMED will be only required when the system will be fully functional and only in two particular cases:

• By the end of the transitional period (24 months after publication in the Official Journal of the European Union) if an equivalent device is not made compliant and registered as a MDR device by that date.
• In case of serious incident or field safety corrective action concerning a legacy device, such device must be registered in EUDAMED at the moment of the serious incident/field safety corrective action reporting in the Vigilance module. The Vigilance module will be available when EUDAMED is fully functional.

Purpose of Vigilance System

Principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, USERs and others by reducing the likelihood of reoccurrence of the INCIDENT elsewhere. This is to be achieved by the evaluation of reported INCIDENTs and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such INCIDENTs.

Medical Device Vigilance System includes:

1. Manufacturers

2. National Competent Authorities (NCA)

3. The European Commission

4. Notified Bodies

5. USERs and others concerned with the continuing safety of MEDICAL DEVICEs

What are Vigilance requirements?

Vigilance requirements includes Incident Reporting System using PSUR’s, FSCA’s, FSN’s, MIR’s, Trend Reports and PSR’s.

Definitions:

Periodic Safety Update Report (PSUR): The main objective of a PSUR is to present a summary of the results and conclusions of the analyses of post-market surveillance data relating to a device or a device group, thus allowing the reporting of any possible changes to the benefit-risk profile of the medical device(s), considering new or emerging information in the context of cumulative information on benefits and risks.

Field Safety Corrective Action (FSCA): A ‘Field Safety Corrective Action (FSCA)’ is a corrective action taken by a manufacturer for technical or medical reasons to either prevent or reduce the risk of a serious incident, which is associated with a device that is made available on the market.

Field Safety Notice (FSN): A ‘Field Safety Notice (FSN)’ is a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.

Trend Report: Any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.

Periodic Summary Report (PSR): A ‘Periodic summary report’ (PSR) is an alternative reporting regime by which the manufacturer, in agreement with the respective national competent authority that is coordinating the periodic summary reporting (and in consultation with the competent authorities referred to in Article 92(8) (a) MDR), can report similar serious incidents with the same device or device type in a consolidated way. Criteria for periodic summary reporting include situations where; the root cause has been identified, a FSCA has been implemented or where the serious incidents are common and well documented.

Submission of Vigilance Requirements in EUDAMED:

PSUR

Step 1: Preparation of PSUR

The PSUR preparation and issuance timeline refers to the period required for the manufacturer to prepare and submit PSUR (for Class III, Class IIa and Class IIb implantable devices according to Article 86) to the Notified Body via EUDAMED or make it available to the Notified Body after the end of the data collection period.

Step 2: Registering a PSUR in EUDAMED using PSUR Web Form for Manufacturer

The PSUR Web form for manufacturer contains all the relevant administrative data necessary for the registration of the PSUR in EUDAMED: certain fields are automatically populated by EUDAMED e.g. Notified Body, Manufacturer, Single Registration Number (SRN) while other data need to be filled up by the manufacturer via EUDAMED Web interface

The manufacturer should create a PSUR reference number which should remain the same for the PSUR updates. In case of grouping of devices within one PSUR, the PSUR reference number relates to the leading device.

When registering a PSUR in EUDAMED, the manufacturer should capture the Basic UDI-DIs of all the Class III or implantable devices belonging to the group via the web interface.

Step 3: Submission of PSUR

Depending on the class of the device and in accordance with Article 86(2), the manufacturer should either submit the PSUR to the Notified Body via EUDAMED or make it available to the Notified Body involved in the conformity assessment.

When EUDAMED becomes fully functional, the manufacturer should upload the PSUR in PDF format into EUDAMED for MDR class III devices or implantable devices and provide the information* of the PSUR Web form directly through the EUDAMED Web interface.

FSCA, FSN, MIR, PSR:

Step 1: Reporting of Serious Incidents and Field Safety Corrective Actions

Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following:

a) Any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product
information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88;

b) Any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available  in the third country.

c) For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action  implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident       reports, on condition that the coordinating competent authority

• Manufacturers should report serious incidents and field safety corrective actions to the respective/relevant national vigilance systems. The new MIR form has already been adapted to MDR requirements and should be used accordingly.
• The current FSCA form should be used (the additional information required under the MDR may be added to the general comments section of the form).

The reporting timelines outlined in the MDR are the following:

1. Any serious incident, that did not involve a death or an unanticipated serious deterioration in a person’s state of health, must be reported immediately after a causal relationship between device and the serious incident has been established or is reasonably possible and no later than 15 days after the awareness date of the serious incident (Article 87(3) MDR),

2. A serious public health threat must be reported immediately, and not later than 2 days after the manufacturer becomes aware of that threat (Article 87(4) MDR),

3. Death or an unanticipated serious deterioration in a person’s state of health must be reported immediately after a causal relationship between the device and the serious incident is established or as soon as such relationship is suspected, and no later than 10 days after the awareness date of the serious incident (Article 87(5) MDR).

Trend Reporting

Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side- effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits.

Step 2: Analysis of Serious Incidents and Field Safety Corrective Actions

• Manufacturers should submit the final report to the respective / relevant national vigilance system.
• Communication with other competent authorities should take place through a dedicated secure directory in CircaBC (organised by the Commission) for MDR devices.
• For Legacy and older devices, the existing Eudamed2 system for NCAR should continue to apply
• Manufacturers should submit the field safety notices to the respective/relevant national vigilance systems.
• The respective/relevant competent authorities should make these field safety notices publicly available/accessible to the public in accordance with theirnational legislation.
• The coordinating competent authority shall inform by email or other suitable communication channels, the other competent authorities, the manufacturer and the Commission that it has assumed the role of coordinating competent authority

Step 3: Submission of FSCA, FSN, Trend Report, PSR and MIR

The use of the new MIR form has been mandatory since January 2020 and as a general rule, we advise sending both the PDF and XML to national Competent Authorities as not all Member States will adopt the new XML (XSD) schema.

FSCA, FSN, Trend Report, PSR can be send in both PDF and XML to national Competent Authorities as not all Member States will adopt the new XML (XSD) schema.

*The templates of FSCA, FSN, Trend Report and PSR reports are not updated as per MDR, the additional information required under the MDR may be added to the general comments section of the form.

For EUDAMED solutions like UDI, Vigilance, ViSU has modules for these to automate. Please reach out to us in case if you want to review or discuss these solutions

MDR addresses the possibility that EUDAMED is not fully functional on the date of application of the MDR (26 May 2021). Until EUDAMED is fully functional, the MDR stipulates that the corresponding provisions of Directives 90/385/EEC4 and 93/42/EEC5 shall continue to apply for the purpose of meeting the obligations regarding the exchange of information.

Alternative solutions to submit and/or exchange information (as required under the MDR)

1.Device Registration:

Manufacturers should refer to the national provisions in Member States establishing product registration schemes. Obligation of UDI assignment (Basic UDI and UDI-DI) to a device applies from 26 May 2021 and Labelling requirements apply gradually, starting from 26 May 2021.

2. Registration of manufacturers , authorised representative s and importers

Manufacturers, authorised representatives and importers should refer to the national provisions in Member States. Please refer to MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.

3. Summary of safety and clinical performance

The SSCP shall be made available to the public upon request without undue delay or the manufacturer shall specify where it is made available to the public. As soon as the functionality is available in Eudamed, the system may be used for the upload of the SSCP even before the notice of full functionality of Eudamed has been published.

4. Certificate of Conformity

Certificates will be made available upon request or will be uploaded in the national system where required.

5. Application for clinical investigations

The application for clinical investigations should take place via the respective national procedures applicable to clinical investigations.

6. CircaBC Centre for Administrations, Businesses and Citizens)

The Commission has made available the list to Member States by means of a dedicated secure directory in the Communication and Information Resources Centre for Administrations, Businesses and Citizens (CircaBC). It is used for following purpose…

• Nomination of experts for joint assessment of applications for notification
• Changes to designations and notifications
• Involvement of notified bodies in conformity assessment procedures
• Clinical evaluation consultation procedure for certain class III and class IIb devices
• Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
• Market surveillance activities

Unique Device Identification (UDI) intended to assign a unique identifier to medical devices within the United States, it marks and identifies individual medical devices throughout their distribution and product life-cycle. Initially, the UDI system was created, developed, and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement.

With certain exceptions, every medical device label needs to have a UDI mark and be composed of two parts:

• Device Identifier (DI) – a mandatory, fixed portion of a UDI that identifies the specific version or model of a device;
• Production Identifier(s) (PI) – a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device. This will be dependent upon the manufacturer’s internal quality system. •   lot or batch number within which a device was manufactured; •   serial number of a specific device; •   expiration date of a specific device; •   date a specific device was manufactured

Therefore, UDI = DI + PI.

UDI History

In 2007, the U.S. FDA developed a labeling system that would uniquely identify every single medical device (MD) on the market. The Global Harmonization Task Force (GHTF) soon recognized the global relevance of such a system and adopted respective guidance that was last released in 2013 by the International Medical Device Regulators Forum (IMDRF), international cooperation of regulators made up of industry stakeholders and GHTF successors. (Interestingly, Medical device manufacturers experienced in the U.S. market have quickly recognized the similarity of the EU regulation as compared to the U.S. Food and Drug Administration’s (FDA) UDI guidelines.

Following the global trend in handling the trace ability of medical devices, the EU Commission has clearly defined the requirements for the implementation of a Unique Device Identification (UDI) System in the final text of the new EU Medical Device Regulation (MDR) 2017/745.

The EU UDI System, like the U.S. UDI requirements, will be implemented in phases, starting with the highest risk classes first, and lowest risk classes last.

Key Differences between US GUDID and EU EUDAMED elements

EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission’s Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC, and 2000/70/EC.

Under these Directives, Member States need to ensure that medical devices that are placed on the market and put into service comply with all provisions of the Directives, including the ‘essential requirements’, and that no obstacles are encountered for the free movement of approved devices. The Directives also require that data be stored in a database in a standardized format. The EUDAMED project aims to address the effective implementation of this provision of the Directives.

Following are the common elements between GUDID and EUDAMED but they likely need to be translated into 24 official languages of the EU:

• Name or Trade name
• Additional product description
• Clinical size
• Storage and handling conditions
• Additional trade names of the device
• Critical warning or contraindications

Deadlines for UDI implementation

Unlike GUDID, EUDAMED is adopting a risk-based approach for UDI submissions.

• Below are the UDI implementation dates according to the class: •   Class I: 26 May 2025 •   Class IIa and IIb: 26 May 202•   Class III: 26 May 2021 •   Implantable devices: 26 May 2021
• For IVDs, the implementation will also be risk-based but delays in the implementation of the IVDR timeline will be different. •   Class D devices should be compliant by 2023 •   Class C & B devices by 2025 •   Class A devices by 2027

*These compliance deadlines are subject to change as the fulfillment of the requirements is dependent on the progress of the EUDAMED implementation and its availability