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Global strategy for Unique Device Identifier (UDI) data

Adam Price

May 24, 2023

4 min read

The International Medical Device Regulators Forum (IMDRF) developed a UDI framework for a globally harmonized system for the identification of medical devices. Adopted in principle by regulatory authorities in many countries, the implementation of UDI regulations and supporting databases is at varying stages of implementation across the globe.

UDI Components

Establishing a UDI strategy involves understanding requirements for both labeling and regulatory database reporting in each country in which your devices will be marketed.

UDI labeling

The UDI is typically presented as a barcode label on device packaging or the device itself (depending on specific requirements). The UDI consists of two major components:

UDI-DI - This is the static portion of the UDI which identifies the manufacturer along with the specific device version. The UDI-DI (device identifier) is assigned by an approved organization, such as GS1, and contains a company prefix and the manufacturer's internal product code. The UDI-DI is the primary identifier to be used in looking up device attributes in country-specific databases and is assigned prior to placing a product on the market.
As GS1 is widely recognized as an issuing agency across global regulators and industry, the UDI-DI is often referred to in the GS1 nomenclature of Global Trade Item Number (GTIN).
UDI-PI - This is the dynamic portion of the UDI which is assigned by the manufacturer and identifies a manufacturer’s lot number, serial number, manufacturing date, expiration date, or other data as required. The UDI-PI actual values do not appear in country-specific UDI databases, but these databases often require information about the type of data that the UDI-PI represents on the device label.

UDI regulatory database requirements

Many countries have established, or are in the process of establishing, databases to store UDI data. In the United States, use of the Global Unique Device Identification Database (GUDID) is mandated for medical devices. In the EU, EUDAMED consists of multiple modules with one specifically established for UDI. The UDI module is currently available for voluntary use, with mandated compliance scaled in transitional periods through 2026.

Currently, the US GUDID database provides for machine-to-machine (M2M) transmission of data, allowing manufacturers to upload product UDI data directly into the database. The EU has established requirements for M2M transmission as well, but these requirements are not finalized. Most other countries do not have M2M capabilities at this time. ‍

Universal UDI ®

While each country defines specific UDI data requirements, there is a core set of data that is consistent across many markets. At Rimsys, we refer to this data as the Universal UDI® data. Storing Universal UDI® data separately from any country-specific UDI data is an important data management strategy. This ensures that data is single-sourced and consistently applied across submissions to regulatory UDI databases and in other locations in the manufacturers’ quality management system where the data may be needed.

When storing UDI data locally, consider that the same information may be required in different formats in different country regulatory databases. Currently, Rimsys supports the specific data requirements of the US, EU, Saudi Arabia, China, South Korea, and Singapore. Additional countries, which are expected to have similar IMDRF style requirements, will be added as those databases are established by regulators and brought to the industry. Some examples of these countries are Australia, Switzerland, UK, Brazil, and India.

Note that outside of the US’s GUDID, UDI databases are in flux in most countries. This means that having a central RIM system to track known and well-established UDI data is increasingly important.

Machine to machine transmission of UDI data

Machine to machine (M2M) transmission is the process in which data is transmitted from a company’s internal database, typically a RIM or PIM/PLM system, to the regulatory UDI database. Currently, the GUDID database in the US is the only database for which machine to machine (M2M) transmission has been fully developed and is fully supported. Rimsys offers M2M data transmission for GUDID and is currently working to establish M2M transmission with EUDAMED.

Synchronizing UDI data

It is important to note that there are really no requirements for a medical device manufacturer to keep a quality record of the UDI data submitted to regulatory databases (the official data of record is the data that has been reported to and is retrievable from the regulatory database). This means that it is up to the manufacturer to declare the actual source of data for the quality system and to ensure that data is in sync where required.

One of the strategies that can be used when implementing a new RIM system, such as Rimsys, is to export data from GUDID, EUDAMED, and other regulatory UDI databases. That data then forms the basis for the UDI data that is input into the RIM system, ensuring consistency in the application of data across other countries’ UDI databases.

Maintaining and updating submitted UDI data

It is important to implement procedures to ensure data in a product’s UDI record is consistently applied throughout your internal systems as well as with the various regulatory databases. While a single data point should be stored in as few places as possible, everything should be done to minimize the chances that data will get out of sync.

Any product data changes must be evaluated for, among other things, the effect on existing UDI data submissions to regulators. The data changes must be evaluated to determine if the UDI-relevant data can be updated in impacted regulatory databases or if an entirely new UDI-DI and record must be reported. In some cases, such as a change to the product’s catalog number or contact phone number, an existing UDI record may simply need an update. In other cases, such as a change to the sterilization requirements, a new UDI-DI and a new record may be required.

EUDAMED considerations

The EUDAMED database and M2M requirements for UDI are still not finalized, but they are much more static than they were even a month or two ago. We believe that it is beneficial for medical device manufacturers to establish and organize the data needed to submit their products to EUDAMED as soon as possible.

Legacy devices are those medical devices and In Vitro Diagnostic (IVD) devices that are compliant to previous directives (MDD, AIMDD, IVDD) that are being placed on the EU market under the allowed transitional period. With the compulsory application of EUDAMED identified in the 2026 timeframe and the expiry of the transitional period in 2024, there was no need for manufacturers to register legacy devices in the EUDAMED system. Today, with the extension of the transitional period for the certification of devices under MDR and IVDR through 2027, legacy devices may now again be subject to submission of UDI data in EUDAMED.

There will be a 24-month transition period for manufacturers to apply UDI data to EUDAMED once all modules go live. However, if you have any type of action requiring interaction with the Vigilance module of EUDAMED, the required UDI information for those devices must be present in EUDAMED prior to that interaction. The Vigilance module is intended to manage all types of vigilance reports, including Manufacturer’s Incident Reports (MIR) and Field Safety Corrective Action (FSCA) reporting. This also includes and requires post market surveillance reporting submission to the Vigilance module such as Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR).

Manufacturers may be surprised with a shortened transitional period for compliance to EUDAMED’s UDI module due to this requirement and should place priority on higher-risk devices due to the increased likelihood of an interaction with EUDAMED’s Vigilance Module.

For additional resources, watch a replay of our webinar, Why UDI is a regulatory concern, not just an operation process - or read our eBooks, The Ultimate Guide to EU MDR/IVDR UDI and The China NMPA UDI System.

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How Market Access Builds Trust in Regulatory Intelligence

Trustworthy AI for medtech market entry requires source traceability, regulatory specificity, and human judgment to turn regulatory intelligence into defensible business decisions.

Featured

Rimsys Announces AI-Native Market Access for Regulated Products

New software gives regulatory and commercial leaders a source-linked, actionable view of market viability, requirements, timing, and risk before committing resources

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From Regulatory Knowledge to Better Market Decisions: A Conversation with Steve Gens and James Gianoutsos

October 1, 2026

4 min read

AI is moving quickly from experimentation to implementation across life sciences. For regulatory teams, that raises a bigger question than where AI can automate a task:

How can organizations use AI to make better decisions while maintaining the traceability, expert oversight, and confidence regulatory work demands?

That was a central theme when James Gianoutsos, Founder and CEO of Rimsys, joined Steve Gens, Founder and Managing Partner of Gens & Associates, on the Regulatory Executive Podcast.

Their conversation explored the changing role of regulatory intelligence, the introduction of Rimsys Market Access, the importance of transparency in regulatory AI, and what these changes could mean for regulatory teams.

Regulatory knowledge has been difficult and costly to scale

For global medtech organizations, regulatory knowledge has traditionally been highly dependent on people.

A company may have specialists responsible for particular countries or regions, along with local representatives, distributors, consultants, and other experts. Those people develop deep knowledge of local regulations, pathways, and expectations.

The problem is that the knowledge often remains distributed across the organization. And maintaining that market-by-market expertise can become expensive as a company expands its portfolio and geographic footprint.

As James described during the podcast, large manufacturers may rely on dozens or even hundreds of internal employees, third-party distributors, local representatives, and other specialists to understand what it takes to bring products into different markets. Smaller organizations may rely more heavily on outside consultants and partners. Either way, the model can be costly and difficult to scale.

But the cost isn't limited to what companies spend on expertise.

Steve described the workflow as a series of “start, stop” cycles: ask a local expert, verify whether the regulation is current, gather more information, and repeat. Each cycle consumes regulatory capacity and extends the time it takes to give the business a confident answer.

That creates another potentially more consequential expense: the cost of waiting.

When it takes months to understand what entering a market will require, commercial and product teams have less visibility into when revenue might begin, what resources will be needed, or whether the opportunity is worth pursuing. Regulatory teams spend valuable capacity assembling and validating information rather than applying their expertise to more strategic work.

Ultimately, scaling regulatory knowledge isn't simply an efficiency problem. It affects how quickly and confidently the business can decide where to invest.

The bigger question: Should we enter this market?

That challenge is central to Rimsys Market Access.

Most market-entry research begins with questions such as: How is the product classified? What's the regulatory pathway? What are the requirements?

Those questions establish whether a company can enter a market. But they don't necessarily tell the business whether it should.

Market Access is designed to help regulatory and commercial teams develop an earlier view of what market entry could involve, including classification, regulatory pathway, timeline, cost considerations, requirements and potential gaps.

For commercial and product leaders, that provides greater predictability before committing budget and resources.

For regulatory leaders, it means starting with a structured plan rather than assembling every market assessment from scratch.

Moving regulatory knowledge from individuals into a shared system

During the conversation, James described one of AI's most significant opportunities as moving knowledge that has historically lived in people's heads into software.

The goal isn't to eliminate regulatory expertise. It's to make that expertise more scalable.

Market Access works from a curated regulatory corpus, allowing market-specific knowledge to be applied across workflows without requiring every initial question to go through the individual who happens to know that jurisdiction. Outputs are designed to trace back to the underlying regulation, guidance, or law.

That can also change where regulatory professionals spend their time. Rather than focusing as heavily on finding information and assembling initial assessments, they can focus on reviewing the evidence, identifying gaps, applying judgment, and advising the business.

Steve described the concept as a subject-matter-expert assistant. James called it a workforce multiplier.

Trust requires opening the regulatory AI “black box”

Speed isn't enough when the information is being used to inform regulatory decisions.

James and Steve returned repeatedly to the importance of knowing where an AI-generated answer comes from. As Steve summarized it during the discussion, transparency builds trust.

Market Access is designed around that principle. Its outputs are grounded in a curated regulatory corpus and traceable to the specific regulations, guidance, or laws supporting them. That gives regulatory professionals the ability to verify an answer rather than simply accept it.

Human judgment remains essential as well. Market Access provides an upfront assessment, not a guarantee of a regulatory outcome. Reviewer interpretation and other factors can still affect what happens during the regulatory process.

The objective isn't to make uncertainty disappear. It's to make what is known, what the sources say, and where uncertainty remains much easier to see.

Connecting the market decision to execution

The discussion also pointed to a broader evolution in regulatory technology: moving from systems that primarily store regulatory information toward systems that help teams act on it.

That's where Market Access and Rimsys RIM play distinct but complementary roles.

Market Access is the planning layer. It helps teams determine whether, when, and how to enter a market.

Rimsys RIM is the execution layer. It manages the registrations, submissions, regulatory changes, and ongoing regulatory work required to act on that plan.

Together, they create a path from the initial market decision through regulatory execution rather than leaving planning and execution disconnected.

A new role for AI in regulatory work

One of the most interesting themes from Steve and James's conversation was that AI's impact may ultimately be less about replacing individual tasks and more about expanding what regulatory teams can accomplish.

Better access to market-specific knowledge can help professionals work across more markets, spend less time gathering information, and devote more capacity to the judgment and strategic work that requires their expertise.

The technology is changing quickly, but the fundamentals of regulatory work remain: reliable information, domain expertise, transparency, and human judgment.

The opportunity is to apply those fundamentals at greater scale while giving the business a clearer answer to the question that comes before execution:

Not simply, “Can we enter this market?”

But, “Should we?”

Listen to the full conversation

Hear the complete discussion between Steve Gens, Founder and Managing Partner of Gens & Associates, and James Gianoutsos, Founder and CEO of Rimsys, on the Regulatory Executive Podcast for more on regulatory AI, market-entry planning, transparency, and the changing role of regulatory teams.

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How Market Access Builds Trust in Regulatory Intelligence

Bethaney Lentz

September 18, 2026

4 min read

Why source traceability, regulatory specificity, and human judgment matter when AI informs a market-entry decision.

Regulatory professionals are not short on AI options. General-purpose tools can answer questions quickly and often sound convincing. But in medtech, a convincing answer is not the same thing as a decision you can defend.

That distinction matters most before a company commits to a new market. Teams need to understand how a product is classified, which pathway applies, how long entry may take, what it may cost, where the important gaps are, and what uncertainty still remains. Commercial leaders need that visibility to decide whether the opportunity is worth pursuing. Regulatory leaders need to know that the assessment is grounded in sources they can verify.

That is the trust standard behind Rimsys Market Access. It is not simply about producing regulatory information faster. It is about helping medtech teams decide whether, when, and how to enter a market before committing budget and resources, with outputs linked back to the regulations, guidance, and laws behind them.

Why fluency is not enough for regulatory work

A general AI tool can be useful for brainstorming, summarizing, and exploring a topic. The challenge comes when an answer has real regulatory consequences. A plausible response may still be incomplete, based on the wrong designation, or disconnected from the current source that should govern the decision.

Medtech makes this especially difficult because the same product can be treated differently across markets and product designations. Medical device, IVD, cosmetic, consumer, OTC, and combination-product considerations can change the regulatory read. A market-entry assessment has to account for that context rather than assume one answer travels cleanly from one jurisdiction to another.

For regulatory teams, the natural next question is: Where did this answer come from? If the system cannot show the underlying authority, the expert still has to rebuild the research before trusting the result. That limits the value of the speed AI was supposed to create in the first place.

Trust starts with a decision you can verify

Market Access is designed around a different outcome. The goal is not to give teams another stream of regulatory information to interpret. It is to provide a source-linked market plan that helps them answer the bigger business question: should we enter this market, not just can we?

For a market assessment, that can include classification, regulatory pathway, timeline, cost considerations, key requirements and potential gaps. The output is designed to give commercial and product leaders an earlier, more defensible view of the opportunity while giving regulatory professionals the detail they need to review the basis for the assessment.

Trust comes from being able to inspect that basis. Market Access works from a curated regulatory corpus spanning more than 200 markets rather than relying on the open web. Answers are linked to the specific regulation, guidance, or law behind them, so a regulatory professional can verify the source instead of being asked to accept an AI-generated conclusion on faith.

Three things make regulatory intelligence more defensible

1. Source traceability

A regulatory answer is more useful when the person reviewing it can follow the evidence. Market Access links outputs back to their underlying regulatory sources. That changes the review process from “Do I trust the AI?” to a more practical question: “Does the cited source support this conclusion for our product and situation?”

That is an important shift for regulatory teams. Instead of assembling every market assessment from a blank page, they can review a structured, sourced plan, challenge assumptions, and focus their expertise on the places where judgment matters most.

2. Regulatory specificity

Trust also depends on context. Market Access is purpose-built for medtech regulatory complexity and supports cross-designation classification. The objective is to evaluate the product in the context of the market and the applicable regulatory framework, then carry that context into the pathway, requirements, timeline, cost considerations, and gaps that shape the market-entry decision.

This is where a purpose-built market-planning platform differs from a generic chat experience. The value is not an impressive answer in isolation. It is a connected assessment that helps the team understand what entering the market is likely to require and whether the opportunity still makes sense once those requirements are visible.

3. Human judgment stays in control

No system can remove every area of uncertainty from regulatory work. Reviewer interpretation and expert judgment still affect outcomes, and Market Access is not designed to promise approval.

Instead, Market Access is designed to make uncertainty more manageable. Regulatory professionals review and validate the work before it moves into execution. They can verify sources, assess the gaps, and apply company and product context that software cannot fully replace. The technology accelerates the research and planning. The regulatory professional remains responsible for the judgment.

What trust looks like in a market-entry decision

Imagine a team evaluating several markets for a new product. The commercial question is not simply whether registration is technically possible. The team needs to know which markets deserve investment now, which may require more evidence or resources, and which could put the revenue window at risk because the pathway is longer or more complex than expected.

Regulatory has a different, but connected, need. They have to understand the classification and pathway, identify the requirements most likely to slow the submission, and confirm that the plan reflects the relevant regulatory sources.

Market Access brings those views together. Commercial and product leaders get earlier visibility into timing, cost considerations, requirements, and risk so they can build a stronger business case. Regulatory teams get a source-linked plan they can review rather than a collection of unsupported conclusions. Both groups are working from the same market-entry picture before significant resources are committed.

Trust is not the end goal. Better decisions are.

It is easy for a conversation about regulatory AI to become a conversation about models, agents, or architecture. Those details matter, but they are not the business outcome.

The real value of trustworthy regulatory intelligence is what it lets a team do next. It can help a commercial leader defend a market investment. It can help regulatory surface issues earlier. It can give both groups a more predictable view of the work ahead before budget, R&D capacity, or launch timing is locked in.

And once the decision is made, the work does not have to stop at an intelligence report. Market Access is the market-planning layer. Rimsys RIM is the execution layer for registrations, submissions, regulatory changes, and ongoing regulatory work. Each can stand on its own, and together they create a path from the market-entry decision into controlled execution.

A more useful standard for regulatory AI

The question for medtech teams should not be whether AI can produce a regulatory answer. It can. The better question is whether that answer is specific enough, traceable enough, and reviewable enough to support a real decision.

Market Access is built around that standard: a defensible view of whether, when, and how to enter a market, grounded in curated regulatory sources and kept under human review. Because when the decision affects revenue, resources, and regulatory strategy, sounding right is not enough. Teams need to see why the answer is right, where uncertainty remains, and what it means for the decision in front of them.

Rimsys Announces AI-Native Market Access for Regulated Products

Bethaney Lentz

September 1, 2026

4 min read

New software gives regulatory and commercial leaders a source-linked, actionable view of market viability, requirements, timing, and risk before committing resources

PITTSBURGH, PA, September 1, 2026 - Rimsys, the heart of medtech regulatory operations, today announced Market Access, a new AI-native product designed to help companies determine whether a market is worth entering and what it will take to get there. Market Access will be available in beta beginning September 1, 2026, with general availability to be announced separately.

Market Access replaces what can be a 6-to-9-month research and assessment process with a same-day, actionable read on market viability. It gives regulatory and commercial leaders the classification, pathway, timeline, cost considerations, and potential regulatory gaps they need to make a more defensible investment decision before committing budget and resources.

Predictability is at the core of Market Access. Rather than simply identifying a regulatory pathway, it helps teams understand what to expect, which requirements or gaps are most likely to slow down a submission, and where uncertainty remains. Every answer traces back to the specific regulation, guidance, or law behind it, allowing regulatory professionals to verify the underlying source rather than simply trust an AI-generated response.

Key features and benefits include:

Same-day market assessment: Provides an actionable read on whether a market is worth entering, replacing research and assessment that can take 6 to 9 months.
Cross-designation classification: Evaluates products across medical device, IVD, cosmetic, consumer, and OTC designations, so the same product receives the appropriate regulatory read regardless of how a given market classifies it.
Clear market-entry requirements: Provides classification, regulatory pathway, timeline, cost considerations, and key requirements before teams commit resources.
Earlier visibility into regulatory gaps: Surfaces the specific requirements and gaps most likely to slow down a submission and helps teams understand their potential severity.
Greater predictability: Provides visibility into anticipated regulatory response windows, risks, and areas of uncertainty so teams can better plan for what lies ahead.
Source-linked intelligence: Traces answers to the underlying regulations, guidance, and laws so regulatory professionals can verify the basis for an assessment.
AI with human oversight: Uses Rimsys AI and Market Manager Agents to accelerate complex regulatory research while keeping regulatory professionals in control of review and validation.
Connected planning and execution: Complements RIM, connecting market-entry decisions with the registrations, submissions, regulatory changes, and ongoing compliance required to execute them.

“Regulatory knowledge has traditionally been highly dependent on individual expertise and market-by-market research,” said James Gianoutsos, Founder and CEO of Rimsys. “Market Access gives companies greater predictability before they make a market investment. Teams can understand whether an opportunity is worth pursuing, what it will take to enter, where regulatory challenges are likely to emerge, and what uncertainty remains. And because every answer is tied to its regulatory source, experts can verify the recommendation rather than simply trust the AI.”

Market Access is powered by Rimsys AI, which works from a curated regulatory corpus spanning more than 200 markets, not the open web. Its Market Manager Agents are AI agents with market-specific regulatory knowledge, including pathways, requirements, and documentation, that support market assessments and global launch planning. The product is also designed to acknowledge areas where reviewer interpretation and expert judgment can affect regulatory outcomes rather than presenting those outcomes as more predictable than they are.

Market Access expands the Rimsys product portfolio from regulatory execution into market planning. Market Access helps regulatory and commercial leaders determine where to compete, while RIM manages the registrations, submissions, regulatory changes, product data, and ongoing compliance required to enter and remain in those markets. Together, they turn regulatory intelligence into coordinated action, helping regulatory teams accomplish more in every hour while giving business leaders greater visibility into opportunities, risk, and the work required to protect and grow revenue.

Beta Availability

Market Access will be available in beta beginning September 1, 2026. During the beta period, Rimsys will continue validating product capabilities and refining workflows ahead of broader commercial availability.

Organizations interested in learning more about Market Access or participating in the beta program can visit rimsys.io/products/market-access.

About Rimsys

Rimsys is the heart of regulatory operations, connecting AI-native market planning with AI-embedded regulatory execution, giving medtech manufacturers one living system from market-entry decision to execution.

Rimsys Market Access is the planning layer, answering not just whether a market can be entered, but whether it should be, returning classification, pathway, timeline, and cost before a team commits budget or resources to finding out. Rimsys RIM is the execution layer, managing registrations, submissions, regulatory changes, and compliance so teams can act on that plan with confidence.

Trusted by 6 of the top 12 global MedTech manufacturers and certified to ISO 27001 and SOC 2, with ISO 42001 certification for AI management systems underway, Rimsys keeps regulatory intelligence, product data, approvals, and change management continuously connected so teams can enter new markets with speed and assurance. Learn more at rimsys.io.

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