EU MDR FAQ

What is EUDAMED?

EUDAMED is the European Commission's database for medical devices under the EU Medical Device Regulation (MDR, Regulation 2017/745). It holds registered economic operators, devices placed on the EU market with their UDI-DI, certificates issued by notified bodies, vigilance and clinical investigation notices, and market surveillance records.

The European Commission publishes part of it openly. MedTech Signal reads the public devices and certificates datasets, plus manufacturer details carried on those records.

Is EUDAMED registration mandatory yet?

Not fully. Under the MDR, use of EUDAMED becomes mandatory only once the Commission confirms the database meets all functional requirements. Until that declaration, many obligations run on transitional national or paper-based procedures, so not every device or actor on the EU market appears in EUDAMED.

That is why a device with no EU record here is reported as "no apparent EU match", never as "not on the EU market" or "not CE marked".

What is an SRN?

A Single Registration Number. Each manufacturer, authorised representative, importer or distributor registered in EUDAMED receives one, prefixed by country code (for example DE for Germany). MedTech Signal uses the SRN as the key for each EU manufacturer's page.

What are UDI-DI and Basic UDI-DI?

The Basic UDI-DI identifies a device group or model family; the UDI-DI identifies a specific product version placed on the market. EUDAMED device records carry both, and MedTech Signal keeps them on each device record so you can trace back to the manufacturer's own identification.

What do EU risk classes I, IIa, IIb and III mean?

EU MDR classes rank regulatory control: class I is lowest risk (mostly self-declared, no notified body certificate needed for most devices), class IIa and IIb need notified body involvement, and class III is highest risk with the strictest conformity assessment. Certificates in EUDAMED apply to classes IIa, IIb and III.

What does CE marking mean on a medical device?

CE marking is the manufacturer's declaration that a device meets the applicable EU legislation — for medical devices, the MDR (Regulation 2017/745) — and has passed the required conformity assessment. It allows the device to be placed on the EU market and to move freely within it.

It is not a quality seal or an endorsement of clinical superiority. It means the device met the regulatory requirements at the time it was placed on the market, and the manufacturer stays responsible for keeping it compliant.

Who grants CE marking?

The manufacturer, not a regulator. For most class I devices the manufacturer self-declares conformity and applies the CE mark itself. For class IIa, IIb and III devices (and certain class I devices with a measuring function, sterile or reusable surgical instruments), a notified body must first audit the manufacturer and issue an EU certificate; the manufacturer may then CE mark the covered devices.

Notified bodies are independent organisations designated by EU member states — they are not part of the European Commission.

How long does a CE certificate last?

An EU certificate issued under the MDR is valid for up to five years, and the manufacturer must apply for renewal before it expires for the device to stay on the market on that certificate. Suspended, withdrawn or expired certificates are reflected in EUDAMED's certificate status.

MedTech Signal's certificate expiry page lists certificates by how soon they expire, taken from the EUDAMED issue and expiry dates. Whether a specific renewal was filed on time is visible only on the EUDAMED record itself — check the linked source page.

Does no CE certificate in EUDAMED mean a device is not CE marked?

No. Class I devices that need no notified body carry CE marking with a self-declaration and generate no certificate record, and EUDAMED registration itself is not yet fully mandatory. So the absence of a certificate (or of a device record) in our data never means a device is not CE marked or not on the EU market.

We report what the records show — for example, "no EU certificate found for this device in EUDAMED" — and never assert that a device is uncertified or off the market.

How is CE marking different from FDA clearance?

They are separate systems with different standards, review routes and numbering. A 510(k) clearance from the FDA does not imply CE marking, and CE marking does not imply FDA clearance — a device can hold one, both or neither. This is exactly why cross-border links in MedTech Signal are shown as "Possible match" until reviewed rather than assumed.

Where does your EU data come from?

Entirely from EUDAMED's public datasets: the certificates dataset and the devices datasets (class III, IIb, IIa, and the all-classes set). Manufacturers are derived from the registration numbers and names carried on device and certificate records. Every record links back to its EUDAMED page, which remains the authoritative version.

How complete is it?

Class III devices load first because they carry the most certificates, followed by lower-risk classes as the import progresses. Because EUDAMED registration itself is not yet mandatory, the database cannot be complete even when our import is — treat missing records as "no apparent EU match".

How often is it refreshed?

Automatic refresh runs on a short schedule (about every 30 minutes) and re-walks the full datasets weekly, so new certificates and device changes appear shortly after EUDAMED publishes them. The EU data sources page shows the exact last refresh times for each dataset.

What do "Possible match" and "No apparent match" mean?

When the database links an EU manufacturer or device to an FDA or Health Canada counterpart, the link is shown as "Possible match" until a person confirms or rejects it — the naming rules and catalogue numbering differ between regulators, so automated links are treated as candidates, not conclusions.

"No apparent match" means no candidate was found. It is a statement about this database only, never about whether a device is licensed in the US, licensed in Canada, CE marked, or on the EU market.

Who can search the EU records?

EU MDR search, the dashboard, certificate expiry and data sources pages are part of the EU MDR add-on, available for $199 per month or $1,990 per year on top of any plan, or on its own. Platform admins have access for review. Ask AI answers EU questions for signed-in users.

Can I get corrected EU data removed or fixed?

Corrections belong with the authoritative source: EUDAMED. If a record looks wrong, follow its link to the EUDAMED page and report it there, or contact the manufacturer. MedTech Signal refreshes from EUDAMED rather than editing regulator records by hand; what we can edit is the match review status on our own cross-border links.

How does a manufacturer register a device in EUDAMED?

Registration is done by the company, not through MedTech Signal. The steps under the MDR are:

1. Register the company in EUDAMED as an economic operator to receive an SRN. Until mandatory use is declared, registration may run through the relevant national procedure — check your competent authority's guidance (for example, the national language portal of your lead authority).

2. Prepare device information: Basic UDI-DI and UDI-DI, device name, risk class, classification rule, and the conformity assessment route.

3. Submit the device record to EUDAMED under your SRN, linking it to the relevant certificate if a notified body issued one.

4. Keep records current — new versions, changes in certificates or authorised representatives should be updated in EUDAMED so downstream databases (including this one) pick them up on the next refresh.

Does MedTech Signal accept device submissions?

No. MedTech Signal is a monitoring and intelligence service, not a regulator and not an entry point to EUDAMED. Nothing submitted here reaches EUDAMED. To appear in the EU database, a device must be registered by its manufacturer in EUDAMED (or via the transitional national procedure), after which our refresh picks it up automatically.

How long until a newly registered device shows up here?

Typically within a refresh cycle after EUDAMED publishes it — usually well under a day for the device datasets, and the import re-verifies everything weekly. If it has been longer, check the EU data sources page for the last refresh time of the relevant dataset.

Who do I contact about EUDAMED access problems?

EUDAMED registration issues go to your competent authority or the European Commission's EUDAMED support, not to MedTech Signal. Questions about our EU module, plans or match reviews go to info@mdsignal.org.