Introduction
Medical device companies today face a complex web of regulations when marketing products globally. Unique Device Identification (UDI) systems have been adopted worldwide to keep track of devices and improve patient safety – an essential pillar of medical device regulatory compliance.
Regulators in major markets like the United States and European Union have implemented UDI requirements, including large databases such as the FDA’s GUDID in the U.S. and the EU’s EUDAMED to uniquely identify devices and monitor them throughout their lifecycle.
In the U.S., the FDA manages its own Global UDI Database (GUDID). They are intended to uniquely identify devices and monitor them throughout their lifecycle.
This article breaks down what manufacturers need to know about UDI compliance, focusing especially on EU requirements under EUDAMED, with a brief comparison to the U.S. GUDID system, and explains how MedQAIR’s MDIS platform simplifies these workflows as part of broader medical device regulatory compliance programs.
UDI Requirements in the United States (FDA GUDID)
In the United States, the Food and Drug Administration’s Global Unique Device Identification Database (GUDID) is the centralized repository for device identification information. The FDA’s UDI Rule (2013) requires device labelers (usually the manufacturer) to do the following:
- UDI on labels: Place the UDI on device labels (in human- and machine-readable form), and directly mark it on reusable devices intended for reprocessing.
- GUDID submission: Submit the device’s identification details to the FDA’s GUDID database (including key device data and the company’s DUNS number as an identifier).
Once submitted, the GUDID record includes the device’s static identifier (UDI-DI) and any production identifiers (UDI-PI, e.g., lot or serial numbers) if applicable, along with the company’s identifying information (using a DUNS number). GUDID entries are publicly accessible via the FDA’s AccessGUDID portal, allowing regulators and healthcare providers to look up device information.
UDI Requirements in Europe (EU EUDAMED)
In the EU, UDI requirements are governed by the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746), with device data registered in the European Database on Medical Devices (EUDAMED). Meeting these obligations is central to medical device regulatory compliance in Europe.
Under the MDR, manufacturers must assign UDIs to their devices and upload extensive device information into EUDAMED. Read this blog to get an overview of UDI under EU MDR and IVDR.
One key difference in Europe is the introduction of the Basic UDI-DI. This is a top-level identifier that groups a family of related devices sharing the same key characteristics. The Basic UDI-DI is used for device registration and in documentation (e.g., certificates and declarations of conformity), but does not appear on any labels. (In other words, customers won’t see the Basic UDI-DI on packaging. Its role is for regulators and internal records.)
EUDAMED captures a broader dataset about each device than GUDID, including (Source):
- The manufacturer’s Single Registration Number (SRN) (the EU equivalent of a company ID, instead of a DUNS).
- Device details like its risk class, intended purpose, and trade name or model.
- Any special warnings or contraindications, and whether the device has been subject to recalls or field safety corrective actions
EU regulations also require that the UDI appear in both human-readable and barcode form on the device’s label and packaging, similar to the U.S. rule. UDI labelling requirements in Europe were phased in by device class from 2021 to 2025, and as of May 2025, all classes of devices must bear UDI markings.
GUDID vs. EUDAMED. What’s the Difference?
- GUDID (FDA, U.S.) is a publicly searchable database containing Device Identifier (DI) data for medical devices marketed in the U.S. It records static attributes of devices (e.g., brand, model, size), while Production Identifiers (PI) such as lot, serial, or expiration date remain only at the product level.
- EUDAMED (European Commission, EU) is a multi-module system covering UDI/Device Registration, Actor Registration, Certificates, Vigilance, and more. It introduces an extra identifier (the Basic UDI-DI) that groups related devices under one umbrella. This Basic UDI-DI is mandatory in technical documentation, Declarations of Conformity, and Notified Body certificates.
While both systems aim for the same outcome of patient safety and transparency, they differ in structure. The EU adds more complexity with Basic UDI-DI, interconnected EUDAMED modules, and traceability duties for all Economic Operators (Manufacturer, Authorized Representative (AR), Importer, Distributor).
How MedQAIR’s MDIS Platform Helps Meet UDI Requirements
MDIS (Medical Device Information System) is MedQAIR’s all-in-one platform designed specifically to simplify medical device regulatory compliance for manufacturers and their partners. It provides a secure, centralized hub to manage all device data, documents, and UDI information across economic operators involved in a device’s lifecycle. In practical terms, MDIS helps manufacturers and their partners stay on the same page regarding UDI compliance.
- Tracking UDI-DI and Basic UDI-DI: MDIS allows users to record each device’s UDI-DI and link it to the corresponding Basic UDI-DI (for EU-regulated devices) within the platform. This ensures all stakeholders use the correct identifiers for each product.
- Centralized Documentation: The platform allows secure, role-based sharing of technical documentation and labeling among stakeholders. Each party always has access to the latest approved documents relevant to their responsibilities. For example, an EU distributor can view the correct local language label and confirm the UDI is present before the device is shipped.
- Automated Regulatory Submissions: MDIS integrates directly with EUDAMED. Once device data is entered, it can be sent through EUDAMED’s API with a few clicks, eliminating manual data entry and errors.
Note: MDIS currently automates registration into EUDAMED. Integration with GUDID and SWISSDAMED (Swiss database on medical devices) is planned for future releases.
By connecting all stakeholders in one system, MDIS creates an audit trail showing that each party has fulfilled their regulatory duties (for example, an Authorized Representative can document their technical file review in the system). This collaborative approach helps prevent compliance gaps and reduces the risk of any missed updates or submissions.
Read more about Medical Device Authorized Representatives and Importers and the Use of MDIS.
Conclusion: UDI Compliance Without the Complexity
Complying with UDI regulations across jurisdictions is challenging, but it has become essential to ensure every device is properly identified and registered in the required databases.
Modern solutions like MedQAIR’s MDIS platform make this process more manageable. By centralizing device data, improving collaboration, and automating submissions, MDIS helps companies meet UDI obligations efficiently as part of their overall medical device regulatory compliance strategy. This means less time on paperwork and more time for innovation and patient safety, with confidence in compliance.
Book a demo today to see how MDIS can simplify your UDI compliance.
