EUDAMED is the European Database on Medical Devices, the central IT system established under EU MDR 2017/745 that registers economic operators, devices, certificates, and market surveillance data. It gives regulators, notified bodies, and the public a single source of traceability across the EU medical device market, linking each record back to the manufacturer that placed the product on the market.
What is EUDAMED?
EUDAMED (European Database on Medical Devices) is the electronic system the European Commission built to support the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746). Its legal basis sits in Article 34 of the MDR. The database collects and links regulatory information across the device lifecycle, from the point a company registers as an economic operator through to market surveillance.
The system is organized into six modules: actor registration, UDI and device registration, notified bodies and certificates, market surveillance, vigilance, and clinical investigations and performance studies. Each module holds a defined slice of the regulatory record. Together they form a shared reference used by manufacturers, authorized representatives, importers, notified bodies, and competent authorities.
Why EUDAMED matters in medical device development
For years, EUDAMED was available on a voluntary basis, so many teams treated it as a side project. That changed with Commission Decision (EU) 2025/2371, published on 27 November 2025, which confirmed that four of the six modules met their functional specifications. Mandatory use of those four modules starts on 28 May 2026 under the transitional provisions of Regulation (EU) 2024/1860.
The stakes are concrete. Without a valid Single Registration Number (SRN) from actor registration, a manufacturer cannot complete the downstream obligations that depend on it. A device that is not registered correctly can face market access delays. Data entered into EUDAMED becomes part of the traceability chain that regulators use during audits and surveillance, so errors are visible and durable. Registration also competes for the same regulatory affairs bandwidth as technical documentation and clinical evaluation, which is why late preparation tends to cascade into missed deadlines.
How EUDAMED works
EUDAMED is structured around six modules, four of which carry mandatory obligations from 28 May 2026:
- Actor registration. Economic operators register to receive a Single Registration Number (SRN), the identifier that links them to every other entry.
- UDI and device registration. Manufacturers assign Unique Device Identifiers and register device data, creating the traceable link between a product and its records.
- Notified bodies and certificates. Notified bodies enter certificate and decision information for the devices they assess.
- Market surveillance. Competent authorities record surveillance activity and coordinate across member states.
Two further modules, vigilance and post-market surveillance and clinical investigations and performance studies, remain under development and will become mandatory under a separate notice, with vigilance functionality expected to follow later.
Registration runs in sequence. Actor registration comes first because the SRN is a prerequisite for device and UDI entries. Manufacturers based outside the EU register through their authorized representative. Devices already on the market before the mandatory date get a transition window that runs into late November 2026, and notified bodies have until 28 May 2027 to upload legacy certificate information. The database ties into the wider MDR framework, so entries must stay consistent with the technical documentation, the Declaration of Conformity, and the labeling that carries the UDI.
Common challenges and best practices
The recurring problem is data readiness, not system access. Teams often find that device data spread across spreadsheets, PLM systems, and legacy files does not map cleanly to EUDAMED fields, so cleanup takes longer than planned.
A few practices help:
- Register as an actor early to secure the SRN, since nothing downstream works without it.
- Reconcile UDI data against the physical labeling and the technical documentation before uploading, so the records match.
- Assign clear ownership for each module instead of treating EUDAMED as one person’s task.
- Keep entries current after the initial upload, because the database expects ongoing maintenance as certificates, contacts, and device status change.
Strong teams treat EUDAMED as an extension of the quality management system, governed by change control and defined responsibilities, rather than a one-time data upload.
How SJML helps with EUDAMED
SJML delivers EUDAMED registration as part of its Compliance-as-a-Service offering. The QARA team handles actor registration and Single Registration Number setup, UDI and device data preparation, and the mapping of technical documentation to EUDAMED fields. Because SJML works across EU MDR and IVDR programs, registration is aligned with the technical file, the ISO 13485 quality system, and product labeling rather than being handled in isolation. For manufacturers based outside the EU, SJML supports the authorized representative pathway and keeps entries current as devices and certificates change.
Frequently asked questions
EUDAMED is used to register and track medical devices, their manufacturers, and related regulatory data across the EU. It holds actor registrations, Unique Device Identifiers, device details, notified body certificates, and market surveillance information. The database gives regulators and the public a shared, traceable record of devices placed on the EU market under the MDR and IVDR.
Mandatory use of EUDAMED’s first four modules begins on 28 May 2026, following Commission Decision (EU) 2025/2371, published on 27 November 2025. That decision confirmed the four modules met their functional specifications and triggered a six-month transition. Vigilance and clinical investigation modules remain under development and will become mandatory later under a separate Commission notice.
Economic operators under the MDR and IVDR must register, including manufacturers, authorized representatives, and importers. Notified bodies enter certificate data, and competent authorities use the market surveillance module. Manufacturers based outside the EU register through their authorized representative, who acts as the point of contact for their devices in the database.
A Single Registration Number (SRN) is the unique identifier EUDAMED assigns to an economic operator during actor registration. It links that operator to every device, certificate, and surveillance record connected to them. The SRN is a prerequisite for device and UDI registration, so securing it early is the first practical step toward EUDAMED compliance.
Related terms
- EU MDR 2017/745
- Unique Device Identification (UDI)
- Authorised Representative
- Notified Body
- Post-Market Surveillance
