EUDAMED Mandatory in 2026
The European Commission has officially started the countdown to mandatory EUDAMED compliance. With Commission Decision (EU) 2025/2371 now published in the Official Journal, four key modules of the European Database on Medical Devices (EUDAMED) are confirmed fully functional. Under the transitional provisions of Regulation (EU) 2024/1860, this starts a six-month clock.
From 28 May 2026, use of these modules is no longer optional. For manufacturers, authorised representatives, importers and other economic operators under MDR and IVDR, EUDAMED has moved from “future project” to an immediate strategic priority that must be built into day-to-day operations.
Key dates & scope at a glance
- 27 November 2025: Decision (EU) 2025/2371 published, confirming four EUDAMED modules as fully functional.
- 28 May 2026: Mandatory use of four modules for new MDR/IVDR devices: Actor registration, UDI/Devices registration, Notified Bodies & Certificates, and Market Surveillance.
- Late 2026 and beyond: Additional deadlines apply for devices already on the EU market and for certificate uploads, aligned with Regulation (EU) 2024/1860.
- Clinical investigations & vigilance modules: Still under development; they will become mandatory following a separate notice and timeline.
The Turning Point: Why the Commission’s Decision Matters
The Commission’s decision is more than a procedural update. It follows completion of an independent audit confirming that the affected EUDAMED systems meet their functional specifications. That finding gives regulators and industry the legal certainty needed to activate hard transition dates.
For MedTech founders and regulatory leaders, this marks a clear shift. EUDAMED is no longer a pilot environment or “best-effort” initiative—it is an enforceable obligation directly linked to MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746). The question is no longer whether you will use EUDAMED, but how quickly you can incorporate it into your regulatory and quality systems.
Which EUDAMED Modules Become Mandatory in 2026?
Decision (EU) 2025/2371 confirms that the following four EUDAMED electronic systems are fully functional and moving to mandatory use for MDR/IVDR devices:
- Actor Registration: The electronic system for registering economic operators (manufacturers, authorised representatives, importers, and in some cases, system and procedure pack producers). Each actor obtains a Single Registration Number (SRN), which is required before other EUDAMED activities.
- UDI & Device Registration: The UDI database and device registration system, capturing core device data, identifiers and Basic UDI-DI / EUDAMED-DI information.
- Notified Bodies & Certificates: The system covering certificates issued by notified bodies, enabling transparent linkage between devices, certificates and scope.
- Market Surveillance: The system supporting national Competent Authorities in coordinating market surveillance activities using EUDAMED data.
The clinical investigations and vigilance / post-market surveillance modules will follow a separate implementation pathway. However, with the core data backbone now fixed, manufacturers need to move from awareness to execution.
Your Strategic Action Plan: A Step-by-Step Guide to EUDAMED Readiness
This roadmap is aimed at MedTech founders and regulatory leads who want to avoid last-minute compliance pressure. Based on our experience supporting MDR and IVDR implementations, proactive planning is the only realistic way to keep EUDAMED manageable alongside ongoing regulatory work.
Step 1 – Secure Your Actor Registration (SRN)
The first critical action for any manufacturer, authorised representative, importer or distributor is to register in the Actor Registration module and obtain an SRN. Without an SRN, you cannot proceed with device registration or other submissions in EUDAMED.
National Competent Authority (NCA) approval timelines vary from country to country, making it highly advantageous to start early. Beyond submitting the application, you should verify that all organisation data is consistent with what national authorities already hold—misaligned addresses, names or identification details can trigger delays or rejections.
Step 2 – Master the UDI & Device Registration Module
The UDI & Device Registration module will be the largest operational lift for most manufacturers, particularly those with broad portfolios or multiple legacy product lines. The module consists of many fields, and some may be tricky to complete. Success requires more than basic data entry; it demands structured preparation and updates to your internal procedures.
Use the checklist below to structure your preparation effort.
| Action Item | Rationale & Expert Tip |
|---|---|
| Understand all data fields | Even though not all fields are mandatory, leaving them empty without understanding their importance is not ideal. Map each field to your existing data sources. |
| Prepare UDI-DI data offline | We recommend first preparing a document listing all UDI-DIs alongside the required fields. This helps ensure accurate, consistent and efficient registration. |
| Plan for your entire portfolio | For companies with large device portfolios, careful planning is essential. Registration can take significant time and resources if approached on a case-by-case basis. |
| Update internal procedures | This is a fundamental shift from older processes that only required internal record updates. Your QMS must now reflect EUDAMED’s external data submission requirements. |
For small and medium-sized enterprises (SMEs) with limited regulatory resources, the scope of this module can feel daunting. Our advice is clear: leverage available guidance and support early. Starting now allows teams to understand the data model, test internal reports, and refine the process before the deadline.
Step 3 – Verify Device-to-Certificate Linkages
Each registered device must be correctly linked to its associated EU certificate(s) in the Notified Bodies & Certificates module. This digital chain allows regulators using the Market Surveillance module to quickly verify certificate status, scope and validity for devices placed on the market.
Practically, this means verifying that your certificate structures, Basic UDI-DIs and device families are aligned, and that your notified body is prepared to upload and maintain accurate certificate datasets in time.
Step 4 – Align PMS with the Market Surveillance Module
With the Market Surveillance module now validated, Competent Authorities will increasingly conduct surveillance activities within EUDAMED. Manufacturers should ensure their post-market surveillance (PMS) and vigilance processes are ready to:
- Receive and interpret information communicated via EUDAMED.
- Respond to surveillance findings and enquiries in a timely, structured way.
- Link PMS outputs back to risk management and, where applicable, to updates in UDI & device records.
By treating these steps as an integrated project rather than isolated tasks, you can turn EUDAMED from a reactive burden into a controlled, auditable process.
The Bigger Picture: Administrative Burden vs Enhanced Transparency
EUDAMED undeniably introduces new administrative tasks and data governance obligations. However, its core purpose is to strengthen safety, traceability and transparency across the EU medical device and IVD markets.
The strategic benefits are clear:
- Improved traceability: EUDAMED is a huge improvement for traceability. It enables stakeholders—regulators, healthcare providers and the public—to confirm that a device has been registered and is legally placed on the EU market.
- Stronger enforcement: A centralised database allows each Member State’s Competent Authority to see which devices and certificates are active on its market, tightening oversight and levelling the playing field against non-compliant competitors.
- Convergence with global trends: The added “administrative pressure” is not unique to Europe—similar expectations exist in other jurisdictions. EUDAMED is part of a wider move towards digital, data-driven oversight.
For those concerned about technical stability, experience from ongoing use provides some reassurance: while the interface can feel clunky, the system has proven to be stable and, most importantly, it works. Ultimately, the benefits of increased safety and public trust outweigh the effort required to implement EUDAMED correctly.
How We Can Help You Navigate the EUDAMED Transition
The Commission’s announcement has made one thing clear: the EUDAMED deadline is firm, and the time for strategic action is now. Many teams already have full MDR/IVDR workloads—trying to bolt EUDAMED on at the last minute usually leads to fire-fighting and data quality issues.
We work with MedTech manufacturers to turn EUDAMED into a structured, time-boxed project rather than an open-ended burden. In practice, that means:
- Designing a portfolio-wide EUDAMED roadmap aligned with MDR/IVDR timelines and notified body expectations.
- Setting up lean processes and templates for Actor registration, UDI/Device data preparation and internal review.
- Reviewing and updating QMS procedures so EUDAMED roles, responsibilities and data ownership are clear.
- Training RA/QA, supply chain and commercial stakeholders so they know exactly what is expected of them.
Work with CENIT on your EUDAMED plan
We help small and mid-sized manufacturers build a realistic EUDAMED plan that fits their resources and risk profile.
- Focused scoping: We map your portfolio, certificates and markets, then define a pragmatic sequence for registrations.
- Data-first approach: We help you structure UDI and device data so it is clean, consistent and audit-ready before it ever touches EUDAMED.
- Execution support: Depending on your needs, we can guide your team or step in hands-on to keep the plan on track.
If you’d like support with your EUDAMED planning, you can send us a short message or book a 30-minute call to discuss whether it makes sense to work together.
Sources & Further Reading
- European Commission. Decision (EU) 2025/2371 on the functionality of certain EUDAMED electronic systems.
- Regulation (EU) 2024/1860 on transitional provisions for MDR/IVDR and EUDAMED.
- European Commission. “The EUDAMED four first modules will be mandatory to use as from 28 May 2026” (News announcement).
- European Commission. EUDAMED Overview – State of play and timelines.
