Welcome to iRM Quarterly Insights
Welcome to the Q2 2026 edition of the iRM Regulatory Newsletter.
In this issue, we highlight the mandatory implementation of EUDAMED (European Database on Medical Devices) and what it means for manufacturers operating under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
As the central platform for regulatory data management, EUDAMED is designed to improve transparency, traceability, and market surveillance across the European Union. Organizations should now ensure their regulatory data, device registrations, and supporting documentation are aligned with the latest requirements.
Regulatory Spotlight: EUDAMED Mandatory Implementation
Overview
Regulation: EU Medical Device Regulation (MDR 2017/745) & IVDR
Focus Area: Mandatory EUDAMED Implementation
Mandatory From: 28 May 2026
EUDAMED has transitioned from partially available modules to a fully operational, legally enforceable system for regulatory data management across the European Union.
The regulation introduces mandatory use of key EUDAMED modules to strengthen transparency, traceability, and regulatory oversight throughout the medical device lifecycle.
This transition follows the structural roadmap introduced under Regulation (EU) 2024/1860, which authorized a gradual, module-by-module rollout of the database. The definitive enforcement countdown was officially triggered by the publication of Commission Decision (EU) 2025/2371 in the Official Journal of the European Union.
Why This Matters
EUDAMED is more than a regulatory database—it is a central pillar of MDR compliance.
It enables:
- Improved traceability throughout the device lifecycle
- Greater transparency across the regulatory ecosystem
- Enhanced market surveillance and regulatory oversight
- A centralized EU platform replacing fragmented national systems
For manufacturers, maintaining accurate and up-to-date regulatory information within EUDAMED is now essential for continued compliance and market access.
Key Mandatory Requirements
1. Actor Registration (SRN)
- Manufacturers, Authorised Representatives, and Importers must register in EUDAMED.
- A Single Registration Number (SRN) is mandatory before device registration can proceed.
- For non-EU manufacturers, registration requests must be systematically verified and approved by both your designated EU Authorised Representative (EAR) and the corresponding national Competent Authority before an SRN is granted.
- Importers must actively maintain their own Actor profiles and face strict traceability governance duties, legally blocking them from placing any product on the market if the underlying manufacturer or device registration is missing from EUDAMED.
2. UDI & Device Registration
Manufacturers must register devices in the UDI/Device module, including:
- Basic UDI-DI (acting as the primary key grouping product families sharing a risk class and intended purpose, required prior to market placement)
- Device identifiers (individual UDI-DIs mapping specific configurations and packaging variants)
- Risk classification
- Intended purpose
Device registration is mandatory before products are placed on the EU market.
3. Notified Body Certificate Uploads
Notified Bodies are responsible for uploading:
- MDR certificates
- Scope and status information
Manufacturers should ensure this information aligns with their technical documentation.
4. Market Surveillance Integration
EUDAMED supports:
- Safety signal monitoring
- Regulatory actions
- Coordination between Competent Authorities
Regulatory authorities will increasingly rely on EUDAMED data for market surveillance activities.
Note: While these core 4 modules are now strictly mandatory, the final two modules—Vigilance/Post-Market Surveillance and Clinical Investigations—remain under separate phased development tracks by the European Commission.
Key Deadlines
| Date | Requirement |
| 28 May 2026 | Mandatory use of core EUDAMED modules |
| 28 Nov 2026 | Registration of legacy devices |
| 28 May 2027 | Completion of certificate uploads |
Recommended Actions
Organizations should continue strengthening their EUDAMED readiness by:
1. Complete Actor Registration
Ensure all applicable entities have obtained their Single Registration Number (SRN).
2. Verify Device Registration
Review UDI information and confirm device records are complete and accurate.
3. Enforce Strict Data Consistency
Establish clear validation checks to ensure zero discrepancy between the data fields populated in your EUDAMED Device Master Record, physical product labeling, Instructions for Use (IFUs), Technical Files, and the certificates issued by your Notified Body. Mismatches will trigger immediate system rejections or audit non-conformances.
4. Strengthen Internal Processes
Integrate EUDAMED requirements into Quality Management System (QMS) processes and establish governance for maintaining regulatory data.
5. Monitor Regulatory Data
Regularly review EUDAMED records to ensure information remains accurate and up to date.
How iRM Supports Your Regulatory Workflow
iRM helps organizations manage evolving regulatory requirements by offering:
- A centralized regulatory library for standards and regulations
- Structured management of regulatory documentation and compliance records
- Critical component management to assess regulatory impact
- Expert regulatory and certification services to support product compliance and certification readiness
- Improved visibility into regulatory requirements affecting products and components
By providing organized regulatory information and impact visibility, iRM helps teams make informed decisions and maintain regulatory readiness throughout the product lifecycle.
Looking Ahead
The mandatory implementation of EUDAMED marks a significant step toward digital, data-driven regulatory compliance for medical device manufacturers.
Organizations that maintain accurate regulatory information, strengthen internal governance, and proactively manage compliance data will be better positioned to support ongoing regulatory obligations and uninterrupted access to the EU market.
Official Reference
European Commission – Overview of EUDAMED
🔗 https://health.ec.europa.eu/medical-devices-eudamed/overview_en
Stay informed. Stay prepared.
Your iRM Regulatory Intelligence Team
