The UDI System and EUDAMED: A Roadmap to Transparency and Traceability Under the MDR

The European Union's Medical Device Regulation (MDR) has ushered in a new era of safety and transparency for the MedTech industry. Two of the most important pillars of this new era are the Unique Device Identification (UDI) system and the European Database on Medical Devices (EUDAMED). They are not just regulatory requirements; they are the digital foundations that enhance traceability, improve post-market surveillance, and increase patient safety across the Union.

However, for many manufacturers, implementing UDI and registering on EUDAMED can be a complex operational challenge. This article provides a clear, step-by-step guide to the obligations related to these two systems, helping your business prepare for the transition.

The UDI System – The "Digital Passport" for Every Device

The UDI system is designed to allow for the clear identification and facilitated traceability of devices. Think of the UDI as a unique "digital passport" for each device, following it throughout its entire lifecycle.

1. Structure of the UDI: UDI-DI and UDI-PI

Each UDI consists of two parts:

• UDI-DI (Device Identifier): This is a unique code specific to a manufacturer and a device model.  It is the "static" part of the UDI, acting as the primary access key to device information stored in the UDI database.
• UDI-PI (Production Identifier): This is the "dynamic" part of the UDI, used to identify the unit of device production.  It can include the serial number, lot number, expiration date, and/or manufacturing date.

For example, while the UDI-DI identifies a specific model of a glucose meter, the UDI-PI identifies each individual production batch of that meter.

2. Manufacturer's Obligations: Assigning and Storing UDI

Manufacturers have the following key responsibilities:

• Assign UDI: Before placing a device on the market, the manufacturer must assign a UDI to the device and all higher levels of packaging, created in compliance with the rules of an issuing entity designated by the European Commission.
• Store UDI: The manufacturer must keep and maintain an up-to-date list of all assigned UDIs as part of the technical documentation.  Other economic operators and health institutions also have an obligation to store the UDI of devices they have supplied or have been supplied with, especially for Class III implantable devices.

3. Requirements for the UDI Carrier on Labels and Packaging

The UDI carrier (e.g., barcode, QR code) must be placed on the label of the device and on all higher levels of packaging. Key requirements include:

• The UDI carrier must contain both the UDI-DI and UDI-PI.
• It must be presented in both machine-readable (AIDC) and human-readable (HRI) formats.
• For reusable devices, the UDI carrier must be placed directly on the device itself, ensuring it is permanent and readable after each cleaning, disinfection, or refurbishing process.

4. UDI Implementation Timeline

The MDR mandates a phased implementation timeline based on the device's risk class. Placing the UDI carrier on the device label is mandatory according to the following deadlines:

• Implantable and Class III devices: May 26, 2021
• Class IIa and IIb devices: May 26, 2023
• Class I devices: May 26, 2025
• For reusable devices that require a UDI carrier on the device itself, the requirement applies two years after the date mentioned above for their respective device class.

EUDAMED – The Central Nervous System of the MDR

EUDAMED is a centralized database designed to enhance transparency, improve coordination, and streamline the flow of information between manufacturers, Notified Bodies, economic operators, competent authorities, and the public.

1. The EUDAMED Modules

EUDAMED is composed of the following electronic systems (modules):

• Actor registration: For registering manufacturers, authorised representatives, and importers.
• UDI database & Device registration: The central repository for storing all UDI-related information.
• Notified Bodies and Certificates: Contains information on Notified Bodies and the certificates they have issued.
• Clinical Investigations: For submitting applications, reporting, and managing clinical investigations.
• Vigilance and Post-Market Surveillance: For reporting serious incidents and field safety corrective actions.
• Market Surveillance: A tool for competent authorities to exchange surveillance information.

2. Registration Process to Obtain a Single Registration Number (SRN)

All manufacturers, authorised representatives (ARs), and importers must register in the Actor module of EUDAMED to obtain a Single Registration Number (SRN). This is a prerequisite before placing a device on the market.

The registration process is as follows:

1. Submit Information: The manufacturer, AR, or importer submits the information required in Annex VI, Part A, Section 1 to the electronic system.
2. Verification by Competent Authority: The relevant national Competent Authority verifies the submitted data.
3. Issuance of SRN: After verification, the Competent Authority obtains an SRN from the system and issues it to the economic operator.

This SRN is critical and will be used for important activities such as applying to a Notified Body for conformity assessment and for accessing EUDAMED to fulfill other obligations.

Conclusion: Transparency and Traceability are Mandatory

The UDI system and the EUDAMED database are fundamental changes brought by the MDR. They are no longer optional but are core operational requirements that demand careful preparation, integration into the quality management system, and dedicated resources. Complying correctly and completely with these obligations not only helps you avoid legal risks but also builds trust with regulators, partners, and customers.

At ITR, we help our partners navigate these complex digital requirements. From integrating the UDI assignment process into your manufacturing workflow to guiding you through the SRN registration on EUDAMED, ITR ensures your operational processes are aligned with the MDR's digital infrastructure.

Don't let UDI and EUDAMED requirements become a barrier. Contact ITR for expert support to ensure your transition is smooth and compliant.

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