UDI management with medtec365Future-proof through digital product registration in EUDAMED by May 28, 2026

Jens Fröhlich

Principal Consultant Operations – Portfolio Management MEDTEC

Unique Device Identification (UDI) is a globally established system for the unambiguous identification of medical devices. It consists of a Device Identifier (DI) – e.g., GTIN or article number – and a Production Identifier (PI) – e.g., batch number or manufacturing date. Both elements must be affixed to the product or its packaging in both machine-readable (barcode) and human-readable (character code) form.

The clock is now running "faster"!

Suddenly things get serious. The deadline is set, but where do you and your company stand? Unclear? Then you need to act now: assess the current situation and define the necessary tasks. Then start now; it's too late for later!

EUDAMED: A duty and an opportunity at the same time

The EU has long recommended the voluntary use of the UDI module. Mandatory use will be... 6 months after official notification of its operational capability in the Official Journal of the EU (OJEU) Expected. A corresponding hotfix was released in July 2025, and now the formal release has taken place. The obligation to register is therefore fixed for May 28, 2026.

Failure to comply can lead to… Market access restrictions, Audit deviations and Sanctions .

The registration process at EUDAMED

Registering a medical device in EUDAMED takes place in the "UDI/Device Registration" module and encompasses several categories, such as basic UDI-DI, product information, identification codes, and packaging details. Depending on the product type and risk class, over 50 mandatory and optional fields must be completed, including UDI-DI, EMDN code, risk class, market entry status, and certificate data. The process is divided into several steps, beginning with actor registration and ending with data validation and submission. For a structured approach, the use of checklists and templates containing mandatory fields, optional information, and validation rules is recommended.

Carefully consider your approach: Incorrect entries in the EUDAMED system can quickly increase costs and may even have implications for approval.

Perhaps it would be better to consider upstream systems here, such as... medetc365 use platforms where you can first enter the relevant data and then upload it.

KUMAVISION: Technology partner for UDI compliance

With the industry solution medtec365 KUMAVISION offers a comprehensive platform for implementing UDI requirements:

• Master data maintenance for EUDAMED and GUDID
• XML export for digital transmission
• UDI generation and Label creation with Nicelabel and Bartender directly from the ERP system
• GTIN management and traceability down to the serial number level

These functions enable a seamless integration into existing processes and ensure Audit security and regulatory compliance.

Strategic advantages for medical technology

“UDI is more than a barcode – it’s a strategic data management issue,” says Jens Fröhlich, Principal Consultant at KUMAVISION. “With medtec365 We are creating the basis for future-proof processes that meet both regulatory requirements and operational challenges.”

You would like to know more?

For more information, visit our Industry website for medical technology.

Kristina Dönninghaus is available for a personal consultation:

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