EUDAMED Scraper — EU Medical Device Registry (MDR/IVDR)

Export the EU's mandatory medical device registry as clean, analysis-ready data: ~3.8 million devices, 32,500+ manufacturers and 5,500+ notified-body certificates, with every regulatory code resolved to plain language.

EUDAMED is where every manufacturer must register every device sold in the EU under MDR (2017/745) and IVDR (2017/746). It has no official API, no export button and no bulk download. This actor is the practical alternative.

Why this is not a five-minute scraper

The registry's own interface hides most of the value behind three obstacles. This actor solves all three:

Obstacle	What it means	How this actor handles it
Codes instead of values	Every field arrives as a token like refdata.risk-class.class-iii or CW010	Resolves against 12 reference tables — including all 423 standardised warning texts — so you get "Class III" and the full warning sentence
Thin list view	The searchable list returns 32 fields of which only ~15 carry data — no trade name, no sterility, no markets	Fetches the full profile per device (61 fields) and merges it
Multilingual text arrays	Trade names and descriptions are stored once per EU language	Flattens to your chosen language with English fallback

On top of that the registry throttles hard — bursts get cut off for minutes, and at busy times a single device profile takes several seconds. This actor paces every request, backs off exponentially and keeps an eye on the run timeout, so a run always finishes with the records it has — instead of dying halfway.

What you get per device

Field	Example
tradeName, primaryDi, basicUdi, referenceNumber	ASSUPRO · 48033439452423 · 8033439ASSUPRO4P · 02PY891SAM
manufacturerName, manufacturerSrn, manufacturerStatus	ASSUT EUROPE SPA · IT-MF-000018178 · Active
riskClass, deviceStatus	Class III · On the market
placedOnTheMarketCountry	Italy
marketsWhereAvailable	Bulgaria, Cyprus, Czechia, Germany, France, Italy, Malta, Romania
nomenclatures	H010201010402 — Polypropylene monofilament with needle for video surgery
isSterile, isSingleUse, isReprocessed, containsLatex, containsCmrSubstance, isEndocrineDisruptor, annexXVIApplicable, isOemProduct	true / false flags
udiProductionIdentifiers	batchNumber, expirationDate
criticalWarnings	full standardised warning texts
instructionsForUseUrl	link to the manufacturer's eIFU document
versionNumber, isLatestVersion, lastUpdated, eudamedUrl	provenance

Manufacturer mode adds company records with SRN, registration date, full postal address, e-mail and phone — the registry's economic-operator data.

Certificate mode returns notified-body certificates with type, status, issue/expiry dates, manufacturer SRN and notified-body SRN.

Use cases

• Regulatory affairs & market access — verify what a competitor has registered, in which countries, under which risk class
• Competitive intelligence in medtech — track new registrations, device families under a Basic UDI-DI, and market withdrawals
• Supplier & partner search — find every EU manufacturer in a device category, with contact details
• Compliance & audit — check certificate validity and expiry against manufacturers you buy from
• Distribution scouting — marketsWhereAvailable shows which EU countries a device is not yet sold in
• Research & data products — a normalised feed of the EU device market
• AI agents — clean schema and plain-language values, callable via MCP

Input examples

Every high-risk (Class III) device currently on the market, with full profiles:

{
    "mode": "devices",
    "risk_class": "refdata.risk-class.class-iii",
    "device_status": "refdata.device-model-status.on-the-market",
    "include_details": true,
    "max_items": 1000
}

All versions of one device family:

{ "mode": "devices", "basic_udi": "8033439ASSUPRO4P" }

German manufacturers with contact details:

{ "mode": "manufacturers", "actor_type": "refdata.actor-type.manufacturer", "max_items": 2000 }

Notified-body certificates:

{ "mode": "certificates", "max_items": 500 }

Output example (shortened)

{
    "tradeName": "ASSUPRO",
    "primaryDi": "48033439452423",
    "basicUdi": "8033439ASSUPRO4P",
    "manufacturerName": "ASSUT EUROPE SPA",
    "manufacturerSrn": "IT-MF-000018178",
    "riskClass": "Class III",
    "deviceStatus": "On the market",
    "placedOnTheMarketCountry": "Italy",
    "marketsWhereAvailable": ["Bulgaria", "Cyprus", "Czechia", "Germany", "France", "Italy", "Malta", "Romania"],
    "nomenclatures": [{ "code": "H010201010402", "description": "POLYPROPYLENE MONOFILAMENT WITH NEEDLE FOR VIDEO SURGERY" }],
    "isSterile": true,
    "isSingleUse": true,
    "containsLatex": false,
    "udiProductionIdentifiers": ["batchNumber", "expirationDate"],
    "instructionsForUseUrl": "https://www.assuteurope.com/public/eifu/12A_MDR_R0.pdf",
    "eudamedUrl": "https://ec.europa.eu/tools/eudamed/#/screen/search-device/8de0765f-..."
}

Performance & limits — stated honestly

• The registry serves 300 records per page maximum, and this is a hard server-side cap that cannot be raised.
• With include_details: true each device costs one extra request. The registry's own speed varies a lot during the day: measured between ~2 devices per second and one device every 5–6 seconds. Plan large exports with a generous run timeout (the default is one hour).
• A run never dies at its timeout. The actor watches the time left and, when it runs short, stops cleanly, keeps every record it has finished and says so in the status message. Records whose full profile could not be loaded in time are left out instead of being sold as complete.
• Filters the registry actually supports are risk class, market status, Primary DI and Basic UDI-DI. Manufacturer-name and country filters are not supported by the registry's search endpoint; filter those in your own pipeline after export. This actor only sends parameters that work, instead of silently ignoring your input.
• If the registry stops answering before any search results arrive, the actor fails loudly with an explanation rather than writing empty rows.

Data protection & legal

• All data is mandatory public disclosure under MDR Art. 33 / IVDR Art. 30. The EU publishes it precisely so it can be inspected.
• Records describe companies and products, not natural persons. The e-mail and phone fields in operator mode are the company's official regulatory contact points as published in the registry.
• No login, no paywall and no access control is circumvented; the endpoints used are the same ones the public web interface calls.
• Not affiliated with or endorsed by the European Commission.

What does a run cost?

$0.02 per run start plus a price per record that drops with your Apify plan — down to half the base price:

Your Apify plan	Per record	1,000 records
Free	$0.03	$30.02
Starter	$0.0225	$22.52
Scale	$0.018	$18.02
Business & Enterprise	$0.015	$15.02

Devices, manufacturers and certificates cost the same per record. You pay only for records actually delivered — if a run stops early because its timeout is near, the records it did not finish are not charged.

For comparison: commercial medtech market-intelligence subscriptions covering this data start in the five-figure range per year.

Auf Deutsch: Medizinprodukte aus EUDAMED exportieren

Dieser Actor exportiert Medizinprodukte, Wirtschaftsakteure (Hersteller, Importeure, Bevollmächtigte) und Zertifikate benannter Stellen aus EUDAMED, der Europäischen Datenbank für Medizinprodukte nach MDR und IVDR. Risikoklasse, Marktstatus, Sterilität, Latex- und CMR-Kennzeichen, Marktverfügbarkeit je Land, CND-Codes und Warnhinweise kommen in Klartext statt als Codes.

Filter: Risikoklasse, Marktstatus, Primary DI, Basic UDI-DI sowie Firmenname bei Herstellern und Zertifikaten. Typische Anwendungsfälle: Regulatory Intelligence, Wettbewerbsanalyse, Marktzugang, Lieferanten- und Herstellerprüfung.

FAQ

Is there an official EUDAMED API or export? No. EUDAMED has a public web interface but no documented API, no export button and no bulk download. This actor is the practical way to get the data as a file.

How many devices are in the registry? About 2.99 million device records, of which roughly 122,000 are Class III. Plus 31,800 economic operators and 4,055 notified-body certificates.

Can I filter by manufacturer or country? Not at the registry level — its search endpoint ignores those parameters, silently. This actor only sends filters that actually work (risk class, market status, Primary DI, Basic UDI-DI) and tells you so, rather than pretending. For manufacturer or country filtering, export and filter in your own pipeline, or use mode: "manufacturers" which returns operators with their country.

Why is it slower than other scrapers? Deliberately, and partly by necessity. The registry throttles bursts (HTTP 429/502) and at busy times takes several seconds per device profile. This actor paces itself, backs off exponentially, and keeps an eye on the run's timeout — which is the difference between a run that finishes and a run that dies at 40 %.

What is a Basic UDI-DI? The identifier for a device family. Passing one returns every device version that belongs to it — the fastest way to map a competitor's product line.

Is this data legal to use? Yes. It is mandatory public disclosure under MDR Art. 33 and IVDR Art. 30, about companies and products rather than natural persons, published by the EU precisely so it can be inspected.

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Support

Bug reports are welcome in the Issues tab.