The European Database on Medical Devices, a key element of the European Union’s regulatory framework for medical devices – introduced under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), is designed for enhancing transparency, traceability, and coordination among economic operators, notified bodies, competent authorities, and the public.
EUDAMED is structured into different interconnected modules, each designed to collect and manage regulatory information throughout the lifecycle of medical devices and in vitro diagnostic devices. These modules allow stakeholders to submit, access, and exchange data related to devices, manufacturers, certificates, vigilance, and market surveillance activities.
After years of delays, phased roolouts, and industry-wide anticipation, EUDAMED has finally become mandatory. As of May 28, 2026 the first four EUDAMED modules have been implemented for economic operators placing medical devices and in vitro diagnostic devices on the European market.
For manufacturers, importers, and other stakeholders, this is more than just another regulatory requirement.
It marks a significant shift toward greater transparency, traceability, and regulatory oversight across the entire device lifecycle.
EUDAMED Modules: How do they work?
EUDAMED is divided into six modules and each module focuses on a specific matter:
- Actor Registration Module
This module enables economic operators, including manufacturers, authorized representatives, and importers, to register and obtain a Single Registration Number (SRN).Without a valid SRN, companies cannot fulfil several key MDR and IVDR obligations.
- UDI/Device Registration Module
This module collects detailed information about devices placed on the EU market, including Unique Device Identification (UDI) data. It supports device traceability, transparency, and improved post-market monitoring.
For many organizations this represents the most resource-intensive aspect of EUDAMED compliance.Common challanges include:
• Incomplete product data.
• Tenuous UDI records.
• Misalignment between technical documentation and registration data.
• Difficulties managing UDI-DI Information.Companies that have not yet established robust UDI data management processes may face significant implementation challenges.
- Notified Bodies and Certificates Module
This module contains information about notified bodies designated under MDR/IVDR and the certificates they issue, suspend, withdraw, or restrict.
Its purpose is to provide greater transparency regarding decive certification status and regulatory compliance.
- Clinical Investigations and Performance Studies Module
It manages applications, approvals, and monitoring of clinical investigations and performance studies conducted in the EU.
- Vigilance and Post-Market Surveillance Module
This module enables reporting and monitoring of serious accidents, field safety corrective actions (FSCAs), and trend reporting.
- Market Surveillance Module
It facilitates cooperation among competent authorities regarding market surveillance activities, including non-compliant devices and the implementation of corrective measures.
The coordinated market surveillance activities across the European Union contributes to faster identification of non-compliant devices and more efficient implementation of corrective actions.
Mandatory Modules for Manufacturers
The first four modules have been mandatory since May 28, 2026, following Decision (EU) 2025/2371, published on November 27, 2025.
Manufacturers need to store data in the EUDAMED and be compliant with the following modules:
- Actor Registration Module
Manufacturers and other economic operators must be registered in EUDAMED to obtain their SRN. Without SRN registration, companies cannot legally interact with EU authorities or submit device-related information.
- UDI/Device Registration Module
Manufacturers will be required to upload detailed device information, including UDI data, ensuring full traceability throughout the supply chain and device lifecycle. - Notified Bodies and Certificates Module
All certificates issued under MDR and IVDR are required to be uploaded and maintained in EUDAMED. This module increases transparency regarding device certification status and regulatory compliance.
- Vigilance and Post-Market Surveillance Module
Serious accidents, field safety corrective actions, and post-market surveillance activities must be reported directly through EUDAMED, standardizing communication with authorities and improving patient safety.
What Do These Changes Imply?
The mandatory use of these modules transformed significantly the regulatory processes across Europe.
Significant expected outcomes include:
- Centralized data management: All regulatory and safety information will be stored and shared through a single EU platform.
- Increased transparency: Authorities, economic operators, and, in certain cases, the public will have improved access to device information.
- Enhanced traceability: UDI implementation will strengthen the ability to track devices across the supply chain.
- Stricter reporting obligations: Vigilance reporting timelines and data accuracy requirements will become more standardized and closely monitored.
Key Deadlines Companies Should Not Ignore
While the mandatory use date of May 28, 2026, has now arrived, another important deadline is approaching, November 27, 2026.
Legacy devices already placed on the market before 28 May 2026 must be registered in the UDI/Device Registration module by this date.
For devices introduced after 28 May 2026, registration must be completed before they are placed on the market.
Companies that postpone implementation risk creating a backlog of registrations, increasing workload and the likelihood of compliance issues later in the year.
What Happens If You Are Not Ready?
Failure to comply with EUDAMED requirements can have significant operational and commercial impact.
Potential risks include:
- Delays in placing devices on the market.
- Restrictions.
- Findings during Notified Body audits.
- Regulatory observations from Competent Authorities.
- Corrective action requirements.
- Market access limitations.
As regulatory authorities increasingly rely on EUDAMED data, missing, inaccurate, or outdated information may become a visible indicator of broader compliance weaknesses.
A Practical Checklist for Companies Still Completing Their Transition
If your organisation has not yet fully transitioned to EUDAMED, now is the time to act.
A structured approach should include:
- Verify Economic Operator Registration: ensure that SRNs have been obtained and organisational data is up to date.
- Review UDI Data Readiness: confirm that Basic UDI-DI, UDI-DI, and associated device information are complete and accurate.
- Align Documentation and Registration Data: verify consistency between certificates, technical documentation, labelling, and EUDAMED submissions.
- Define Internal Responsibilities: establish clear ownership for data management, updates, and ongoing maintenance.
- Train Relevant Personnel: ensure Regulatory Affairs, Quality, Supply Chain, and Commercial teams understand their responsibilities under the new framework.
EUDAMED Is No Longer a Future Project
For years, EUDAMED was viewed as a future requirement; important, but not yet urgent. That is no longer the case.
As of May 28, 2026, EUDAMED has become an integral part of the European regulatory landscape for medical devices and IVDs.
Companies that have invested early in data governance, regulatory processes, and compliance readiness are already benefiting from a smoother transition.
For those still catching up, the priority should be clear: close compliance gaps now before they become regulatory or commercial risks.
What Will Be the Impact on Manufacturers?
Manufacturers will need to adapt both organizational processes and technical systems. The main impacts include:
- Regulatory readiness: Companies must ensure accurate and complete data submission across multiple modules.
- Process restructuring: Internal procedures for device registration, vigilance reporting, and certification tracking may require updates.
- Resource allocation: Additional regulatory, quality, and IT resources may be needed to manage EUDAMED submissions and maintenance.
- Data governance challenges: Maintaining consistent and validated device data will become a critical compliance requirement.
- Training needs: Personell must be properly trained to manage EUDAMED regulatory expectations and responsibilities.
How ChemSafe Can Help
Successfully implementing EUDAMED requires more than simply uploading data into a database. It requires a structured approach to regulatory compliance, data management, and process integration.
ChemSafe supports manufacturers, authorised representatives, and importers through:
- EUDAMED readiness assessments
- Gap analyses
- SRN registration support
- UDI data management
- Device registration activities
- Regulatory compliance reviews
- MDR and IVDR training
Contact our experts today and get ahead of EUDAMED compliance!
