EUDAMED registration — overview
Regulatory basis - MDR Art. 28–33 / IVDR Art. 25–30. EUDAMED is the European database on medical devices — the central information infrastructure underpinning MDR and IVDR. Manufacturers, EU REPs, importers, and distributors must all register as economic operators.
Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
What is EUDAMED?
EUDAMED (European Database on Medical Devices) is the EU's central electronic platform for medical device information. It serves as the single point of registration, transparency, and data exchange for:
- Economic operators (manufacturers, EU REPs, importers, distributors)
- Devices (UDI and device characteristics)
- Notified body certificates
- Clinical investigations and performance studies
- Vigilance reports and FSCAs
- Market surveillance actions
EUDAMED is operated by the European Commission (DG SANTE). Phased implementation began with MDR application in May 2021 and continues.
EUDAMED's six modules
| Module | Content | Who accesses |
|---|---|---|
| 1. Actor registration | Economic operator registration; SRNs | Manufacturers, EU REPs, importers, distributors |
| 2. UDI / Device registration | Device characteristics linked to Basic UDI-DI | Manufacturers; public view of key data |
| 3. Notified body & certificates | NB designations and all issued certificates | NBs; public view of certificate status |
| 4. Clinical investigations | Registration and reporting of clinical investigations / performance studies | Sponsors, NCAs; some public data |
| 5. Vigilance | Serious incident reports, FSCA notifications, trend reports | Manufacturers, NCAs |
| 6. Market surveillance | NCA actions, safeguard procedures | NCAs, Commission |
Public vs. restricted access
Some EUDAMED data is publicly accessible — supporting transparency and patient information:
| Publicly accessible | Restricted access |
|---|---|
| Device name, description, intended purpose | Detailed vigilance report content |
| Basic UDI-DI and device class | Clinical investigation protocols (pending ethics) |
| Certificate status (valid/expired/suspended) | Full technical documentation |
| Manufacturer/EU REP name and contact | NCA correspondence |
| SSCP (for Class III / IVDR Class D) | Market surveillance operational data |
Registration obligations by actor
Manufacturers
- Register as economic operator → receive SRN
- Register each device (Basic UDI-DI and device data)
- Register all UDI-DI packaging configurations
- Upload SSCP (for Class III / IVDR Class D and C where applicable)
- Submit vigilance reports (Modules 5)
- Register clinical investigations (Module 4)
EU Authorised Representatives
- Register as economic operator → receive SRN
- Linked to the non-EU manufacturer they represent
- May submit vigilance reports on manufacturer's behalf
Importers
- Register as economic operator → receive SRN
- Record their SRN on the device label (where required)
Distributors
- Register as economic operator → receive SRN (where required by national law or regulation)
Phased implementation timeline
EUDAMED has been implemented progressively. Registration obligations became mandatory according to the following approximate schedule:
| Obligation | Deadline |
|---|---|
| Actor registration (economic operators) | 26 May 2021 |
| UDI / Device registration — Class III / IVDR Class D | 26 May 2021 |
| UDI / Device registration — Class IIa, IIb / IVDR Class B, C | 26 May 2023 |
| UDI / Device registration — Class I / IVDR Class A | 26 May 2025 |
| Vigilance module — mandatory use | Phased by NCA readiness |
| Clinical investigation module — mandatory use | Phased |
Always verify current status at ec.europa.eu/tools/eudamed — the Commission publishes notices when each module becomes mandatory.
Related pages
- Economic operator registration
- Device registration & UDI upload
- Certificates & notified body data
- Public-facing modules & timelines
- EUDAMED UDI registration
- EUDAMED vigilance module
Official references
| Reference | Description |
|---|---|
| MDR Art. 28–33 | EUDAMED registration obligations |
| MDR Art. 100–105 | EUDAMED technical provisions |
| IVDR Art. 25–30 | IVDR EUDAMED obligations |
| Commission Implementing Regulation (EU) 2017/2185 | EUDAMED structure |
| EUDAMED user guides | ec.europa.eu/tools/eudamed |