EUDAMED (European Database on Medical Devices) is the EU's central database for medical device information under EU MDR and IVDR. It includes actor registration, device registration, UDI, notified body certificates, clinical investigations, and vigilance data.

What is an EUDAMED SRN?

The SRN (Single Registration Number) is issued after successful actor registration in EUDAMED. It is required for placing devices on the EU market and for interactions with notified bodies.

When is full EUDAMED mandatory?

Mandatory EUDAMED modules are being phased in. Actor and UDI registration are currently required for MDR devices. Check the European Commission's EUDAMED timeline for the latest mandatory dates by module.

Book EU EUDAMED Actor & UDI Setup Support

Book EU EUDAMED actor registration and UDI setup support online. Compare vetted MDR/IVDR specialists for EUDAMED actor ID, SRN, and device UDI registration. Instant pricing.

✓ 3 active providers available right now · EUR 552 – 684

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Compare before booking: Review inclusions, exclusions, turnaround, and communication channels.
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Live availability: 3 active providers available right now for this service.

What you can compare here

Total price: See live price ranges and instant pricing rules where available.
Coverage & scope: Markets served, what is included, and what is explicitly excluded.
SLA & responsiveness: Acceptance SLAs and typical turnaround windows.
Add-ons: Optional extras you can book next (shown as add-on chips).
Onboarding time: How quickly providers can start and what you need to supply.

Compare providers (instant pricing + book)

Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 600	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 684	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 552	24h	3–7 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

needActorRegistration (Required)
true/false (must choose at least one of actor/udi)
needUdiSetup (Required)
true/false
diCount (Required)
min 0; required if needUdiSetup=true
complexity (Required)
simple|normal|complex
turnaround (Required)
standard|rush
desiredOutputs (Required)
min 1
buyerNotes (Optional)

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Market

EU / EEA

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Regulation

EU MDR / IVDR

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Turnaround

5–20 business days

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Pricing

Per actor / per device

Want to read provider profiles and reviews first? Compare all EUDAMED registration specialists →

How it works

1

Describe your EUDAMED needs

Tell us whether you need actor registration (SRN), UDI/device registration, or both, and your device portfolio size.
2

Compare EUDAMED specialists

View fees and turnaround from providers who help manufacturers navigate EU EUDAMED registration flows.
3

Receive your SRN and UDI registration confirmation

Your specialist guides your team through the EUDAMED portal steps and confirms successful registration of your actor ID and devices.

What is EUDAMED and who must register?

EUDAMED (European Database on Medical Devices) is the EU's central digital infrastructure for medical device information under EU MDR 2017/745 and EU IVDR 2017/746. It contains six interconnected modules: actor registration, UDI/device registration, notified body certificates and notified body designations, clinical investigations, vigilance reporting, and post-market surveillance. Actor registration is the first required step for all economic operators — manufacturers, authorized representatives (EC REPs), importers, and distributors — who are involved in placing CE-marked medical devices on the EU market. Without a valid actor registration and Single Registration Number (SRN), an EC REP cannot be formally designated and device registration cannot proceed.

What is the EUDAMED SRN and why does it matter?

The Single Registration Number (SRN) is the unique identifier issued by EUDAMED after successful actor registration. It is required on your device labelling (for the EC REP) and in notified body certificates. Notified bodies will verify your SRN as part of the conformity assessment process, and competent authorities use it to track post-market obligations. The SRN is tied to your legal entity and the role(s) you have registered for (manufacturer, EC REP, importer, distributor). If you are both a manufacturer and an importer for different products, separate registrations or role combinations may be needed — this is one of the most common EUDAMED setup errors.

UDI registration in EUDAMED

After actor registration, manufacturers must register their device identifiers (UDI-DIs) in the EUDAMED UDI database. For Class III and implantable devices, this was required from the MDR application date. For Class IIa and IIb, mandatory UDI registration timelines have been phased. Class I devices have the longest transition period. Each UDI-DI entry in EUDAMED requires: basic device data, device classification, product description, storage and handling conditions, UDI-DI value and issuing entity (GS1, HIBCC, or ICCBBA), and associated notified body certificate references for higher-risk classes. EUDAMED data must be kept current — outdated entries can trigger notified body findings during surveillance audits.

Common EUDAMED registration challenges

The most frequently encountered EUDAMED setup issues include: registering the wrong legal entity (the EUDAMED actor must exactly match the legal entity on the CE label and notified body certificate); creating duplicate actor registrations when the account already exists from a previous EC REP setup; incorrect role selection (manufacturer vs. importer vs. distributor); mismatched UDI-DI values between EUDAMED entries and physical device labels; and delayed updates when device versions or EC REP details change. Working with a consultant who has hands-on EUDAMED portal experience significantly reduces these errors — which can otherwise take months to correct through the national competent authority verification process.

Frequently asked questions

What is EUDAMED?: EUDAMED (European Database on Medical Devices) is the EU's central database for medical device information under EU MDR and IVDR. It includes actor registration, device registration, UDI, notified body certificates, clinical investigations, and vigilance data.
What is an EUDAMED SRN?: The SRN (Single Registration Number) is issued after successful actor registration in EUDAMED. It is required for placing devices on the EU market and for interactions with notified bodies.
When is full EUDAMED mandatory?: Mandatory EUDAMED modules are being phased in. Actor and UDI registration are currently required for MDR devices. Check the European Commission's EUDAMED timeline for the latest mandatory dates by module.

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