Understanding EU UDI Deadlines and Benefits for Medical Device Companies

EU’s Competitive Landscape

The latest statistics from 2024 reveal that the European medical technology market was estimated at roughly €170 billion with the top five biggest markets being Germany, France, United Kingdom, Italy, and Spain. Based on manufacturer prices, the European medical device market is estimated to make up 26.4% of the world market. It’s the second-largest medical device market after the United States (46.4%).¹

Since the European Union (EU) medical device market is highly competitive, delays in compliance can lead to missed opportunities. Companies that maintain timely compliance can enter the market faster and establish their product quicker while delayed compliance can make it harder to regain market share.

A Standardized Framework for Device Identification

The key regulations that companies must comply with to prepare for the European database for medical devices (EUDAMED) and the unique device identification (UDI) system are the EU medical device regulation 2017/745 (MDR) and, for in-vitro diagnostic devices, regulation 2017/746 (IVDR). These regulations form the legal basis for all requirements related to traceability, transparency, and safety.

EUDAMED is integral to the UDI system. Manufacturers must register their devices with the EUDAMED and regularly update details on safety, clinical data, labeling, vigilance reports, and other required information. UDI registration helps track the device from production, through distribution, to its use in healthcare settings, making it easier to trace a device in case of issues like recalls or adverse events.

What Are the Elements of UDI?

UDI is a distinct numeric or alphanumeric code used to identify medical devices throughout product’s healthcare lifecycle. The codes are generated by product owners based on globally accepted standards for device identification.

Two important standard elements of UDI:

• Device Identifier (DI) identifies the labeler and the model/version of a device. The DI is a required component and considered the static portion of the UDI, meaning it is the same for all instances of the product model/version.
• Production Identifier (PI) identifies one or more variable characteristics, such as manufactured date, expiration date, lot number, or serial number. The PI is considered the dynamic portion of the UDI, meaning the PI value changes according to the production controls.

When combined, the DI and the PI form the full-length UDI. The DI is always first and is followed by the PI if it has a value. This is often shortened to the formula of UDI = DI + PI.

What Are the Benefits of EU UDI?

While many organizations may view UDI registration as yet another regulatory requirement or another round of bureaucracy, it was created to improve the safety, transparency, and traceability of medical devices across Europe. The benefits extend to manufacturers, healthcare providers, regulators, and ultimately patients.

Key benefits of the EU UDI system include:

• Improved patient safety.
• Enhanced device traceability.
• More efficient recall and vigilance processes.
• Greater transparency across stakeholders.
• Streamlined supply-chain operations.
• Global harmonization of regulatory standards.
• Acceleration of healthcare digitization.

Important EU UDI Dates and What They Mean

The timing for EU medical device organizations to register UDI data depends on a few factors such as:

• Device classification.
• Whether the device is new or already on the market?
• When the EUDAMED UDI/device-registration module becomes mandatory.

Key UDI Dates as of late 2025:

• The UDI/device registration module of EUDAMED was declared functional by the European Commission in November 2025.
• According to the transitional rules (Regulation [EU] 2024/1860), the UDI/device module becomes mandatory six months after that notice, i.e., as of May 28, 2026.²

From May 28, 2026, forward:

• Completion of all device data uploads will most likely be due by mid-2027.

Which Organizations Must Respond and When

The UDI rule affects a wide range of stakeholders across the medical device ecosystem, not just manufacturers. Under the EU MDR and EU IVDR, the UDI requirements apply to multiple actors.

Organizations that are affected:

• Medical device manufacturers and device labelers.
• Importers and distributors.
• Healthcare institutions (hospitals, clinics, purchasing entities, and healthcare providers).
• EU competent authorities (access UDI device data in EUDAMED for safety actions such as recalls, field safety notices, etc.).
• Notified bodies (verify during conformity assessments that the manufacturer’s UDI system complies with MDR/IVDR).

When they must act:

• If placing a new device on the EU market on or after May 28, 2026: Register the device (UDI/device data) in EUDAMED before first placement.
• If continuing to market an existing (legacy) device as of May 28, 2026: Register it in EUDAMED by November 27, 2026 (unless it is discontinued).
• For all devices: Ensure the required UDI labeling on device/packaging by the class-specific MDR/IVDR deadlines (2021–2027).

Preparing for EU UDI Compliance

What UDI Means for European Companies Now

If you want to sell new devices in the EU after the UDI/device module becomes mandatory, you must register those devices in EUDAMED before you can sell them. For older or already-sold devices that were on the market before the mandatory date, you will usually get a transition period, often up to 12 months after the rule takes effect to finish your registration.

When the first sales unit of a new regulated device (compliant with the MDR or IVDR) is planned to be placed on the EU market on or after the mandatory UDI/device module use date (mid-May 2026), the registration must be completed before the device may be placed on the market.

Does the U.S. Require Medical Devices to Have a UDI?

The U.S. has already implemented its own UDI system managed by the FDA. U.S. companies must comply with FDA requirements which have been in place since 2014. The FDA’s global unique device identification database (GUDID) is the central repository for UDI data in the U.S. For devices marketed in both the U.S. and EU, companies must manage compliance with both FDA GUDID and EUDAMED, often requiring harmonized data management and submission processes.

Who Are the EU UDI Issuing Agencies?

The EU-UDI systems are not approved by a centralized UDI authority. The responsibility is divided across the following three entities:

1. The European Commission:

• Establishes the regulatory framework (MDR/IVDR).
• Approves and publishes the list of EU-designated UDI issuing agencies.

Current EU-Designated UDI Issuing Entities:

A manufacturer must choose one of these four and follow its technical rules. These organizations are authorized to issue UDIs that meet EU MDR/IVDR requirements:

• GS1 (Global Standardized System).
• HIBCC (Health Industry Business Communications Council).
• ICCBBA (International Council for Commonality in Blood Banking Automation) for blood, cell, and tissue products using ISBT-128.
• Informationsstelle für Arzneispezialitäten, Germany (IFA) GmbH.³

2. The Manufacturer:

• Is legally responsible for assigning UDIs to its own devices.
• Must ensure UDIs meet the MDR/IVDR format rules.
• Must upload device data into EUDAMED’s UDI/device registration module.

3. Notified Bodies (when applicable):

• Do not approve UDIs themselves.
• Verify that the manufacturer’s UDI system complies with MDR/IVDR requirements during conformity assessments.
• Check UDI assignments, label content, and EUDAMED registration (once fully deployed).

The Role of PLM in Supporting EU UDI Compliance

Product lifecycle management (PLM) supports EU UDI compliance by creating a single source of truth for all information related to device identification. Because UDI information must remain consistent across labeling, packaging, instructions for use, manufacturing systems, enterprise resource planning (ERP), distributors, and EUDAMED submissions, PLM centralizes these attributes in one single controlled environment. It can manage key identifiers such as the Basic UDI-DI, UDI-PI, device models, and packaging levels under structured version control.

PLM systems can also automate the creation and maintenance of UDI data on labels and packaging by integrating with UDI-issuing entities and driving updates into label templates and downstream manufacturing or enterprise systems, reducing manual effort and error.

In addition, PLM is essential for compiling and exporting comprehensive and accurate data required for EUDAMED device registration, preventing the risk of inconsistencies associated with reentering information in multiple systems.

Throughout the entire lifecycle of the device including introduction, modifications, packaging updates, discontinuation, and post-market activities, PLM helps maintain compliance by synchronizing UDI changes with engineering, regulatory, quality, manufacturing, and supply-chain workflows. PLM provides the end-to-end data integrity, automation, and traceability needed to meet EU UDI requirements efficiently and reliably.

UDI Is Helping Drive Competitive Advantage

Within the competitive medical device landscape, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7,000 generic devices groups.⁴

As more products enter the market, medical device companies must prioritize compliance. If manufacturers fail to submit or update information in EUDAMED on time, their devices might not meet the regulatory requirements for market access. Delays in registration can result in a lack of access to the EU market, or worse, the suspension of a device’s marketability.

With the right PLM system in place, medical device companies will have a solid data management foundation to not only meet various regulatory requirements but also maintain controlled product development and quality processes, ensuring successful commercialization.

Discover how Arena PLM can help you stay ahead of Europe’s evolving medical device regulations. Read our white paper.

Sources:

1. MedTech Europe: Facts & Figures: https://www.medtecheurope.org/wp-content/uploads/2025/09/medtech-europe-facts-and-figures-2025-digital-1.pdf
2. EU UDI Helpdesk: https://webgate.ec.europa.eu/udi-helpdesk/en/udi-carrier/deadlines.html
3. EU UDI Helpdesk: https://webgate.ec.europa.eu/udi-helpdesk/en/udi-assignment/issuing-entities.html
4. World Health Organization: https://www.who.int/health-topics/medical-devices