And Why That Creates Bigger Problems Over Time

As EUDAMED implementation accelerates and the UDI/Devices module becomes mandatory in May of 2026, many MedTech companies have made a seemingly practical decision. They hand EUDAMED compliance to IT.

At first glance, the logic feels sound. EUDAMED is a system. It requires integrations, data transmission, and technical connectivity. IT already owns those capabilities, so the project lands there.

But this handoff reveals a deeper misunderstanding of what EUDAMED actually represents. It is a tool that enables manufacturers to meet ongoing regulatory obligations that touch product data, submissions, post-market activities, and lifecycle management.  EUDAMED also enables manufacturers’ ACTOR partners like Notified Bodies, Authorized Representatives, Importers, and Distributors to meet their obligations under those EU regulations. Treating it as an isolated, one-time IT project creates risks to EU regulatory compliance that grow and spread across partners over time. MDR/IVDR regulatory compliance cannot be established and maintained with a one-time technical integration.

The first problem with delegating EUDAMED to IT is what it signals internally. It frames the regulation as a single event rather than a continuous program.

EUDAMED is not just about getting data into a database. It requires ongoing updates tied to regulatory changes, product modifications, vigilance activities, certificates, and market status. Every change across the product lifecycle can trigger downstream updates in EUDAMED.

When EUDAMED is positioned as a one-time event, organizations underestimate the scope, effort, and ownership required to maintain compliance over time. That gap does not show up immediately. It appears months later when updates are missed; data falls out of sync, or responsibilities become unclear.

IT teams often take on EUDAMED with the expectation that once the pipes are built, the work is largely done. In reality, the opposite happens.

As regulatory data changes, IT becomes the default escalation point for updates they do not own and cannot validate. They are asked to manage regulatory timelines, interpret data requirements, and support continuous updates that fall outside their core mandate.

This creates friction on both sides. Regulatory teams feel blocked by technical dependencies. IT teams feel burdened by compliance work they were never meant to manage. Over time, updates slow down, workarounds emerge, and risk quietly increases.

The most damaging consequence of delegating EUDAMED to IT is architectural. When EUDAMED operates outside of a centralized Regulatory Information Management system, organizations lose the opportunity to reuse data and reduce burden across the business.

Most of the data required for EUDAMED already exists within product information management and resource planning systems. Product registrations, certificates, submissions, UDI, and post-market data are not new. They are part of the regulatory lifecycle. When EUDAMED is disconnected from RIM, teams are forced to duplicate work, reconcile inconsistencies, and manually manage updates across systems.

Instead of becoming a natural extension of regulatory operations, EUDAMED turns into another silo. One that increases workload rather than streamlining it.

Establishing and maintaining regulatory information in EUDAMED is a regulatory obligation, not a technical one. While IT plays a critical role in enablement and integration, there should be a strong partnership between regulatory and IT (or a third-party submitter), but IT shouldn’t own it completely.

When EUDAMED is managed as part of a centralized RIM approach, organizations gain consistency, traceability, and reuse. Regulatory teams can leverage existing data, control updates at the source, and reduce the ripple effects of change across departments. IT supports the infrastructure, but regulatory owns the process.

This shift also changes how organizations think about compliance. Instead of reacting to EUDAMED as a standalone requirement, they treat it as part of a broader regulatory operating model that supports long-term compliance and growth.

Delegating EUDAMED to IT is rarely a conscious strategy. It is usually a symptom of fragmented regulatory operations and unclear ownership.

As MedTech companies scale globally and regulatory expectations continue to evolve, these handoffs become harder to sustain. EUDAMED exposes the cost of treating regulatory compliance as a series of isolated projects rather than an ongoing operational discipline.

The companies that navigate EUDAMED successfully are not the ones with the most complex integrations. They are the ones that anchor EUDAMED within regulatory operations, supported by centralized RIM systems that establish data consistency and reduce duplication, improve visibility, and spread the burden across the organization in a controlled way.