EUDAMED - European Database on Medical Devices

EUDAMED is the European Union's official registry of medical devices and in vitro diagnostics - the IT system established by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), built to give what the regulation calls "a living picture of the lifecycle of medical devices available in the European Union." The European Commission (DG SANTE) operates it under Commission Implementing Regulation (EU) 2021/2078.

Six modules make up the picture: Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, Clinical Investigations, Vigilance and post-market surveillance, and Market Surveillance. Following Commission Decision (EU) 2025/2371 of 26 November 2025, four of them - actors, devices, notified bodies and certificates, market surveillance - turned mandatory on 28 May 2026, closing a six-month transition opened by Regulation (EU) 2024/1860. Clinical investigations remain under Commission analysis and vigilance is still in development, which makes this the rare regulatory corpus whose completeness boundary is drawn in law rather than guesswork.

At the August 2026 research pass the mandatory core held 3,210,828 device UDI-DI records, 4,535 notified-body certificates, 53 designated notified bodies and 2,592 competent-authority entries. Within the Datadory catalog of 1,744 datasets averaging 7.81 on quality, this record scores 7/10 - statutory authority no aggregator can manufacture, joined to a compliance graph few registries attempt. Get a sample of this dataset and we cut rows toward whichever module your question lives in.

One record per surface, flattened for reading, exactly as the fields arrive:

# Device -- one UDI-DI record, one specific model version
basicUdi                     : 471070188GBQC
primaryDi                    : 04710701883258
riskClass                    : refdata.risk-class.class-i
manufacturerName             : Homecare Enterprise Co., Ltd.
manufacturerSrn              : TW-MF-000012356
deviceStatusType             : refdata.device-model-status.on-the-market
authorisedRepresentativeName : KOMAS Medical Technology GmbH
versionNumber                : 1

# Certificate -- one notified-body certificate behind that manufacturer
actorSrn          : DE-MF-000006413
actorName         : AIRAmed GmbH
notifiedBodySrn   : 0633
certificateNumber : Z-25-052-S-IX-E
certificateType   : refdata.certificate-mdr-type.quality-management-system
issueDate         : 2025-09-17T00:00:00
expiryDate        : 2030-09-16T00:00:00
certificateStatus : refdata.certificate-status.issued

# Notified body -- one designation record
name              : TUeV NORD CERT GmbH
eudamedIdentifier : 0044
legislationStatus : refdata.designation-notification-status.active (MDR)

# Market surveillance -- one four-year review report
reportIdentifier : 4YR-SI-2025-1
caReference      : SI-CA-020
reportingCountry : Slovenia
reportingPeriod  : 2022-01 : 2025-12
submissionDate   : 2026-08-18

Read the graph, not any single row. The device names its manufacturer; the manufacturer carries a Single Registration Number; a certificate issued by notified body 0633 stands behind that same SRN until 2030-09-16; and when a competent authority such as SI-CA-020 finishes reviewing its market-surveillance performance, the four-year report lands in a fourth table keyed to the same country. Four surfaces, one joinable compliance graph - which is why the registry rewards teams that model relationships rather than copy single lists.

The coded values are a feature, not noise. refdata.risk-class.class-i resolves to Class I under the MDR rule set, refdata.device-model-status.on-the-market is a literal market-state flag, and refdata.certificate-status.issued separates live certificates from withdrawn or suspended ones. Deliveries decode these reference codes alongside the raw values, so filters read in plain regulatory language.

Ten field groups carry the analytical weight, all verified against live records during the research pass rather than inferred from column headers. Identity splits in two on purpose: basicUdi groups every device sharing an intended purpose and risk class, while primaryDi pins one model version inside that family - keep both keys and every analysis rolls up or drills down without remapping. Responsibility splits the same way: manufacturerName with its Single Registration Number names who puts the device on the market, and authorisedRepresentativeSrn names who answers for it inside the Union when the manufacturer sits outside.

The certificate fields turn compliance into arithmetic. issueDate and expiryDate come as ISO datetimes ready to diff, so a certificate-expiry calendar is a sort operation, not a document-reading exercise. On the surveillance side, reportIdentifier and reportingPeriod key the four-year review reports a competent authority submits on itself - the self-audit layer most coverage of device safety never reaches.

Three chips summarize the footprint:

• Geography: the twenty-seven EU member states plus EEA-relevant manufacturers registering devices for the Union market from anywhere in the world. A Taiwanese manufacturer shipping through a German authorised representative appears once, fully attributed, on both ends of the chain - the widest single lens on device commerce any regulator publishes.
• Temporal: a live registry, not an archive - voluntary submissions accumulated from December 2020 onward, mandatory filing since 28 May 2026, and every record carrying its own version number and last-update timestamp. History deepens as obligations bite; longitudinal designs get comparability from the timestamps rather than assumptions.
• Granularity: individual device models at UDI-DI level, certificates one document per row, economic operators at Single-Registration-Number level, and surveillance reports per authority per period. The unit of observation is a product, a credential, a company or an audit - matched to the question instead of forced through one shape.

Set against the wider Datadory catalog - average quality score 7.81 across all 1,744 datasets - this one scores 7/10: breadth bounded by statute, precision enforced by it.

API, files, or your warehouse. Daily, weekly, or hourly.

Pick the channel your stack already speaks and set the cadence to match the decision being fed - bulk files for overnight warehouse loads, structured responses for dashboards that refresh themselves, direct loads into Snowflake, BigQuery or Redshift so registry rows land one join from your product tables.

Normalization happens before anything reaches you. Reference codes arrive decoded next to their raw values, the four module tables ship with their keys intact so the device-to-manufacturer-to-certificate path stays navigable, and every shipment includes validation rows and a coverage profile. Want a certificate-expiry calendar for one notified body, or an edge list of manufacturers to authorised representatives for a market-entry map? Say so in the sample request - both are standard first cuts.

Five jobs this registry does better than any commercial reconstruction of it.

• Watch competitors enter the market. New UDI-DI rows are product launches filed with a regulator before they are announced in a press release; deviceStatusType separates models arriving from models already selling.
• See certificate trouble first. With 4,535 certificates dated to the day, sorting by expiryDate flags every quality-management credential lapsing this quarter - yours, or a supplier's - while renewal is still a conversation instead of a supply break.
• Build the compliance graph. Device, manufacturer, authorised representative, notified body, certificate share keys by construction, so a supplier-qualification workflow becomes joins rather than a document chase across twenty-seven national sources.
• Benchmark the conformity landscape. Fifty-three designated notified bodies and 2,592 competent-authority entries support real questions about capacity and concentration: who certifies whom, in which member state, at what volume.
• Ground market-entry diligence. Before signing a distribution agreement, check the counterparty's claims - risk class, market status, certificate standing - against the registry record instead of the brochure.

Competitive-intel product teams lead - launch tracking and certificate monitoring are scheduled queries here, not analyst sprints. See competitive intel use cases.

Data scientists get a labeled, keyed graph - millions of device rows joined to makers, representatives and certifiers - for supplier-risk and market-structure models. See data scientists use cases.

Investors and quants read certificate expiries and market-status flips as leading indicators around regulated revenue. See investors quants use cases.

Journalists, academics & students cite the regulator itself when writing about device oversight in Europe. See journalists academics use cases. The common thread: everyone here needs registry-grade facts about who sells what in the EU, and no secondhand copy improves on the filing.

Provenance note - one operator runs the whole thing: the European Commission (DG SANTE) owns all six modules, which is why identifiers agree across them and a device's manufacturer resolves to the same SRN everywhere it appears. No crosswalk tables, no fuzzy matching between publishers.

Completeness note - the mandatory core is actors, devices, notified bodies and certificates, and market surveillance; clinical investigations remain under Commission analysis and the vigilance module is still in development. Datadory scores this record 7/10 with ten field groups documented to type and example, and states the boundary rather than smoothing over it.

Where to go next - Data.gov HHS Health Technology Catalog covers the American metadata layer, and our head-to-head comparison settles which to sample first. For harm-side evidence on US devices, the openFDA Device Adverse Events (MAUDE) API pairs naturally with this registry's market-side record. Start from the best health care technology datasets ranking or the health care technology data hub to see where this record lands in the slice.