EUDAMED 2026: Why Late Movers Face Serious Compliance Risk

The mandatory shift to the EUDAMED database is approaching quickly. From May 28, 2026, EUDAMED becomes the legally required EU system for key MDR (Medical Devices Regulation) and IVDR (In Vitro Diagnostic Regulation) processes. It consolidates key economic operators, device, certificate, and post-market information into one centralized platform for traceability and oversight. 

From that date, EUDAMED is no longer an optional route for the covered activities. New devices must be registered in the database before they can be placed on the EU market. Moreover, legacy devices under the former Directives must meet the UDI (Unique Device Identification) and device registration deadline by November 27, 2026. 

With the deadline drawing closer, the pressing question is no longer when implementation will happen – but whether your data, ownership, and submissions will be ready to stand up once EUDAMED becomes the single source of truth and compliance gaps become impossible to ignore.

Value-chain risks of EUDAMED non-compliance 

Once the database becomes mandatory, missing or inconsistent data is no longer just a documentation gap. It can quickly turn into a direct risk to market access and operational continuity. 

EUDAMED market access risk

If a device is not properly registered, or cannot be clearly linked across actor, device, and certificate records, it may not be legally placed on the EU market after May 2026.

In practice, that can mean shipment holds, delayed launches, or even product withdrawals while records are corrected. With the deadline approaching, correcting windows narrow and commercial consequences grow.

Fines and escalation without an EU-wide ceiling

EUDAMED requires member states to apply penalties that are effective, proportionate, and dissuasive. While there is no EU-wide cap, compliance gaps can cause an alarming dent on resources. 

Where gaps are systemic or repeatedly identified, enforcement can even go beyond fines, extending to corrective action orders, and increased inspection pressure. Moreover, loss of market access can also give rise to unexpected time and cost, when teams need stability the most.  

Data quality risk: Late remediation becomes costly and slow

Most readiness issues originate outside the database. When device identifiers and attributes are not aligned across regulatory and operational systems, submissions trigger rework and repeated corrections. Close to the deadline, this creates avoidable bottlenecks: 

• The same records are fixed repeatedly, 
• exceptions increase, and 
• core device datasets must be rebuilt under pressure while supply and launches continue. 

Vigilance and market surveillance risk

If incident reporting, field safety actions, or supporting documentation is delayed or inconsistent, issues can escalate faster and remain under scrutiny longer. Centralized vigilance and market surveillance increase transparency for authorities across the EU.

Once EUDAMED becomes the compliance reference point, inconsistencies are easier to detect and harder to contain, increasing reputational exposure alongside regulatory risk.

Mandatory EUDAMED modules in May 2026

The EUDAMED rollout is module-based because the EU chose to activate database components as soon as they were verified as fully functional. For late movers, this means enforcement arrives faster, with far less room to catch up at the last minute.

The four modules now declared mandatory, form the operational core of EUDAMED:

• Actor Registration: Registers economic operators and issues the SRN (Single Registration Number), which is required for most downstream activities. 
• UDI and Device Registration: Creates the EU-wide record for device and UDI data, making data quality and consistency essential for compliant submissions. 
• Notified Bodies and Certificates: Connects certificates and assessment outcomes to device records, increasing visibility and reducing tolerance for mismatches. 
• Market Surveillance and Vigilance: Centralizes serious incident reporting and field safety actions, enabling faster coordination and follow-up across member states. 

Together, these four modules define the minimum viable compliance state for EU market access after May 2026. Dive deeper into these modules (and their requirements) with the osapiens comprehensive EUDAMED handbook.

EUDAMED readiness: What to prioritize with less than 100 days to go

With the May 28, 2026, deadline approaching fast, companies that secure EUDAMED readiness early reduce exposure and create long term value. The osapiens HUB for Medical Devices enables manufacturers to move faster with a central, secure, and fully validated environment to manage and validate devices for EUDAMED.

It supports early testing, validates data quality before mandatory use, and integrates with the database for compliant submission and ongoing maintenance. The result is more stable data flows, fewer last-minute corrections, and clearer control over what is submitted and when.

EUDAMED Webinar
With less than 100 days to go until EUDAMED becomes mandatory, join our webinar to understand what must be ready before May, and how to prioritize to avoid deadline pressure. Register now!