The UDI (Unique Device Identification) requirement will be fully effective starting in 2026. For many companies in the medical technology and pharmaceutical industries, this raises the question: How well are our processes, data, and systems prepared for the upcoming requirements?
In a free 30-minute UDI readiness consultation, we will work with you to assess your current situation and identify any UDI-related gaps, as well as initial areas for action, including validation requirements and data models.
Request an appointment now!

From 2026, new comprehensive rules will apply to manufacturers who want to introduce products to the EU market. These include the UDI requirement, the EU AI Act, and the Health Technology Assessment Regulation (HTAR). This causes high costs, delays the launch of new medical devices on the EU market, and can lead to heavy penalties. Those who fail to act now risk not only falling behind, but also jeopardizing the future viability of their company. This guide provides managers in medical technology companies with a practical overview of the most important regulatory requirements and best practices.


