Medical device manufacturers are increasingly being required to submit structured device information to UDI databases in the markets where their products are registered. Depending on the jurisdiction, this can include device identifiers, packaging information, device characteristics, storage conditions, and other regulatory attributes.

But preparing compliant UDI data is only part of the challenge. Manufacturers must also determine how that information will be submitted and maintained over time.

At one end of the spectrum is manual entry through a regulator’s online portal. Some regulators also provide intermediate options such as bulk file uploads. At the other end is machine-to-machine (M2M) submission, where systems electronically exchange regulatory data with limited or no manual intervention in the transmission process.

Each approach has a place. The right choice depends on submission volume, frequency of change, internal resources, technical capabilities, number of markets, and expected growth.

UDI Submission Is Not Always Simply Manual or M2M

Before comparing the approaches, it is important to understand that regulators may provide several submission methods.

For example:

• FDA GUDID – Web application or HL7 SPL/XML submission
• EUDAMED – User interface, XML bulk upload/download, or M2M
• AusUDID – Online portal, Excel bulk upload (up to 200 records), HL7 SPL M2M, or M2M through GS1 Australia’s National Product Catalogue (NPC)
• swissdamed – Online editor, XML upload, or REST API-based M2M

The appropriate method depends on factors such as submission volume, frequency, and technical capabilities. For example, EUDAMED guidance suggests its user interface for up to 100 devices, XML bulk upload/download for 100–1,000, and M2M for more than 1,000.

While these thresholds do not apply universally, they illustrate a useful principle: as UDI submission demands grow, more automated methods can become increasingly practical and scalable.

Manual Submission: Simple and Practical at Lower Volumes

Manual submission is the most straightforward model. An authorized user logs into the regulatory UDI database, creates or selects a device record, enters the required information, resolves data validation errors, and submits the record. For manufacturers with small portfolios and infrequent submissions, this can be entirely appropriate.

Where Manual Entry Works Well

Manual entry generally requires less technical infrastructure to establish because organizations can submit UDI data directly through the regulator’s portal without implementing and maintaining an automated system-to-system connection.

It can therefore make sense when:

• Device volumes are low
• Records change infrequently
• Only a limited number of markets are involved
• Internal IT resources are limited
• Submission volumes do not justify automation

FDA, for example, describes its GUDID web application as best suited to organizations with only a few records to submit. Swissmedic similarly positions the swissdamed online editor for organizations with limited product portfolios or little experience with automated interfaces.

Where Manual Processes Begin to Struggle

The economics and operational burden change as portfolios and submission activity grow.

1. Repeated Data Entry – Device information already maintained in ERP, PLM, PIM, RIM, spreadsheets, or other internal systems may need to be entered again into a regulatory portal. Each additional data entry creates another opportunity for transcription errors, incorrect code selections, inconsistent units, or missed attributes. The problem becomes greater when similar product information must be maintained across multiple UDI databases.
2. Large-Scale Changes Require More Effort – UDI compliance is an ongoing process, with new devices introduced and existing product, packaging, and regulatory information changing over time. Depending on the applicable requirements, these changes may require updates to existing records or the assignment and submission of new device identifiers. Updating several records manually may be straightforward. Updating hundreds or thousands can create significant operational effort.
3. Device Data Exists Across Multiple Environments – Internal product data and regulatory records exist in separate environments. With manual submission, teams must identify relevant changes in their internal data and manually update the corresponding UDI records, increasing the effort required as the number of products, changes, and markets grows.

Bulk Upload: The Middle Ground

The choice does not always have to jump directly from manual entry to full M2M automation. Some UDI databases provide bulk-upload capabilities.

EUDAMED allows users to generate compliant XML files and manually upload them. AusUDID allows up to 200 UDI records to be submitted using its Excel bulk-upload template.

This approach can reduce repetitive data entry without requiring the technical infrastructure associated with M2M.

Bulk upload can therefore be attractive when:

• Manual record-by-record entry has become inefficient
• Submission volumes are moderate
• Changes occur in batches
• The organization can generate structured files
• Full M2M integration is not yet justified

However, the process remains partly manual. Files must still be prepared, uploaded, validated, monitored, and corrected as necessary. As submission volumes and frequency continue to increase, organizations may eventually reach another threshold where M2M becomes more efficient.

M2M: Automating UDI Data Exchange

M2M submission replaces manual entry or file upload with a direct system-to-system exchange. Once UDI data has been prepared and approved, software formats it according to the regulator’s database requirements, transmits it through the supported interface, and receives the resulting acknowledgements or submission status.

How this exchange works varies by regulatory database. GUDID supports HL7 SPL/XML submissions through the FDA Electronic Submissions Gateway, while EUDAMED uses XML through its DTX infrastructure. AusUDID supports M2M through direct HL7 SPL submissions or GS1 Australia’s National Product Catalogue (NPC), while swissdamed uses JSON through a REST API.

As a result, M2M is not a single standardized connection that can be reused across every UDI database. Manufacturers supporting multiple markets must account for each regulator’s data model, message format, data validation rules, connectivity requirements, and technical onboarding process.

What M2M Can Automate

M2M can reduce the manual effort involved in preparing, submitting, and monitoring UDI data by connecting regulatory submissions to a structured product data management and workflow process. Depending on the implementation, automation can help:

1. Source device data from authoritative internal systems.
2. Map and transform data to regulator-specific attributes, code values, and formats.
3. Enrich records with regulatory information not available in source systems.
4. Validate data against applicable regulatory business rules before submission.
5. Generate and transmit submissions in the required message format through the regulator’s supported interface.
6. Monitor responses including acknowledgements, validation errors, and submission status.
7. Support corrections and resubmissions when issues are identified.

M2M can automate much of the regulatory data exchange, but automation does not make inaccurate source data correct. Effective data ownership, governance, and quality controls remain essential to a reliable UDI submission process.

Why M2M Becomes More Valuable at Scale

The business case for M2M generally strengthens as submission volumes, frequency, and regulatory complexity increase.

1. Reduce Repetitive Data Entry – M2M allows UDI data maintained electronically to flow through defined mappings and transformations instead of being repeatedly entered into regulatory portals. As the number of products and updates grows, this reduces both the staff effort required for submission and the risk of transcription errors introduced during manual entry.
2. Validate Data Before Submission – M2M submission platforms can apply database-specific business rules before data is transmitted to the regulator. Teams can identify missing UDI attributes, invalid code values, formatting issues, and other data validation errors earlier in the process, reducing avoidable submission failures and the effort required to investigate and resubmit records.
3. Process Larger Submission Volumes Efficiently – Manual effort typically increases with the number of records that must be entered or updated. M2M allows large batches of new and changed records to move through the same automated process, making it easier to absorb portfolio growth and higher submission activity without increasing manual workload at the same rate.
4. Standardize the Submission Process – M2M can support a consistent workflow for preparing, validating, approving, submitting, monitoring, and correcting UDI data. This reduces reliance on individual users performing each submission differently and creates a more controlled, repeatable process as submission activity expands across products and teams.
5. Scale Across Multiple Regulatory Markets – Many UDI attributes are shared across regulatory databases, even though each destination has its own data requirements and submission specifications. M2M allows common product data to be reused while applying the mappings, additional attributes, data validation rules, and transformations required for each market, reducing the need to recreate the submission process for every regulatory destination.

Automation Does Not Replace Data Governance

M2M improves the efficiency and consistency of UDI data exchange, but the quality of each submission still depends on the quality and governance of the underlying product data. Incorrect source data, such as an inaccurate storage condition, packaging relationship, or regulatory attribute, can still be transmitted through an automated process.

A well-designed M2M operating model should therefore combine automation with appropriate data and process controls, including:

• Defined authoritative sources for device attributes
• Clear data ownership and stewardship
• Pre-submission data validation
• Review and approval workflows
• Change history and audit trails
• Exception management
• Submission monitoring

Together, these controls help ensure that automation is applied to trusted and appropriately reviewed device data. The effectiveness of M2M therefore depends not only on database connectivity itself, but also on the data governance, workflows, and systems supporting the submission process.

Manual vs. Bulk vs. M2M: Comparing Submission Approaches

Consideration	Manual Entry	Bulk Upload	M2M
Typical fit	Low volumes	Moderate volumes	High volumes
Technical setup	Low	Moderate	High
Record submission	Individual entry	Batch submission	Automated submission
Human intervention	High	Moderate	Low
Repetitive data entry	High	Moderate	Low
Large scale updates	Low efficiency	Moderate efficiency	High efficiency
Source system integration	Low	Moderate	High
Pre-submission data validation	Portal based	File based	System based
Submission timing	User initiated	User initiated	User or system initiated
Error handling	Manual	Semi-automated	Automated
Multi-market data reuse	Low	Moderate	High
Ongoing IT involvement	Low	Moderate	High
Scalability	Low	Moderate	High

The right approach is therefore not necessarily the most automated one. It is the approach whose level of automation is justified by the organization’s portfolio and operating model.

Five Questions to Guide Your Decision

1. How many records do you manage?

Small portfolios can remain practical to manage manually. As record volumes increase, bulk submission and eventually M2M become increasingly valuable.

2. How frequently does your UDI data change?

A stable portfolio may not justify automation. Frequent launches, corrections, packaging changes, and updates strengthen the case for M2M.

3. How many regulatory markets do you support?

Manual entry may remain manageable in a limited market footprint. Multiple jurisdictions increase repetitive work and strengthen the value of reusable and automated data flows.

4. Are your source systems ready for automation?

M2M works best when required device attributes have clear ownership and reliable sources. Poorly governed source data should be addressed before automating submissions.

5. Where is your UDI program heading?

If volumes and markets will remain stable, manual or bulk methods may be sufficient. Expected growth, acquisitions, and increasing submission activity strengthen the long-term case for M2M.