Is an EU MDR Authorized Representative mandatory?

Yes. Any manufacturer established outside the EU/EEA must appoint an EU MDR Authorized Representative (EC REP) before placing a CE-marked medical device on the EU market.

What does the EC REP do on my behalf?

The EC REP acts as your legal point of contact for EU competent authorities and notified bodies. They register in EUDAMED, receive official correspondence, and can initiate field safety corrective actions on your behalf.

Can one EC REP cover multiple device families?

Yes. Most EC REPs offer portfolio-based pricing that covers multiple device families and legal entities under a single mandate, which is usually more cost-effective.

How long does the appointment process take?

Typically 5–15 business days depending on dossier readiness and the complexity of your device portfolio. Rush onboarding may be available from some providers.

What is the difference between EC REP and a Notified Body?

A Notified Body assesses conformity and issues CE certificates. An EC REP is your legal representative in the EU market — they do not certify your device but are required alongside CE marking for non-EU manufacturers.

Appoint an EU MDR Authorized Representative in Minutes

Find and appoint a vetted EU MDR Authorized Representative (EC REP) online. Compare annual pricing, coverage scope, and book instantly — no RFQ needed.

✓ 3 active providers available right now · EUR 1,656 – 2,052

Why this page is different

Instant pricing: See a price estimate immediately (no back-and-forth RFQ needed for these services).
Compare before booking: Review inclusions, exclusions, turnaround, and communication channels.
Charged only when accepted: You are charged only after a provider accepts your order and scope.
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 1,800	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 2,052	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 1,656	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.

billingPeriod (Required)
monthly|quarterly|annual
deviceClass (Required)
I|IIa|IIb|III
deviceFamiliesCount (Required)
min 1
legalEntitiesCount (Required)
min 1
includeOnboardingAppointmentPack (Optional)
one-time add-on (mandate + onboarding pack support)
includeEudamedActorUdiSupport (Optional)
optional add-on (may be recurring or one-time per provider plan)
includeVigilanceLiaisonSupport (Optional)
recurring add-on
buyerNotes (Optional)

🏛️

Market

EU / EEA

📋

Regulation

EU MDR 2017/745

⏱️

Onboarding

5–15 business days

💰

Pricing

Annual retainer

Want to read provider profiles and reviews first? Compare all EU Authorized Representative providers →

How it works

1

Enter your device details

Tell us your device class, number of device families, and legal entities that need EC REP coverage.
2

Compare vetted EC REPs with instant pricing

See annual fees, scope, and onboarding timelines side-by-side from qualified EU MDR Authorized Representatives.
3

Appoint and get your mandate pack

Confirm your choice and your new EC REP will prepare your appointment mandate and onboarding checklist.

What is an EU MDR Authorized Representative (EC REP)?

Under EU MDR 2017/745, any medical device manufacturer established outside the European Union or European Economic Area (EEA) must designate an EU Authorized Representative — also called an EC REP — before their device can be CE-marked and placed on the EU market. The EC REP is a legal entity established in the EU that formally accepts responsibility for the device on behalf of the manufacturer. This is not a formality: the EC REP's name and address must appear on the device label, and they are officially registered in EUDAMED as the point of contact for EU competent authorities.

What does the EC REP actually do?

The EC REP's core obligations under EU MDR include: registering in EUDAMED and maintaining your device's UDI registrations; receiving and forwarding official correspondence from national competent authorities and notified bodies; cooperating with market surveillance activities; participating in Field Safety Corrective Actions (FSCAs) and recalls where required; and ensuring post-market surveillance information reaches the manufacturer. A good EC REP will also proactively alert you to regulatory changes in the EU that affect your device portfolio and assist with vigilance reporting queries.

How much does an EU Authorized Representative cost?

Annual EC REP fees typically range from EUR 250 for a simple single-entity, single-device-family Class I portfolio to EUR 3,500 or more for complex Class III portfolios with multiple legal entities and device families. Most EC REPs use portfolio-based pricing, where you pay a base annual fee plus an increment per additional device family or legal entity. Add-ons like EUDAMED UDI support, vigilance liaison, or rush onboarding will carry additional fees. On Cruxi Bridge, you see exact annual pricing instantly based on your specific portfolio before you commit.

How to choose the right EC REP

Key factors to evaluate include: (1) EU-jurisdiction registration — confirm the EC REP is genuinely established in an EU/EEA member state and can legally accept the role; (2) device class experience — Class IIb and III devices carry greater post-market obligations, so your EC REP should have specific experience with higher-risk device categories; (3) EUDAMED expertise — ensure they actively manage EUDAMED registrations, not just sign mandate documents; (4) vigilance response SLA — critical if you have a device with an active post-market history; and (5) portfolio pricing model — avoid EC REPs that charge per-device rather than per-family, as portfolio growth can become expensive.

Switching EC REP: what you need to know

Switching EC REPs requires you to terminate the existing appointment mandate and issue a new one for the incoming EC REP. Both the old and new EC REP's details must be updated in EUDAMED. Critically, your device label must eventually be updated to reflect the new EC REP contact details — though a grace period applies during the transition. Your new EC REP will typically guide you through the administrative steps. On Cruxi Bridge, the incoming EC REP confirms their scope and onboarding timeline at the point of booking, so you know exactly what to expect before switching.

EC REP vs. PRRC: understanding the difference

The EU MDR also requires larger manufacturers to designate a Person Responsible for Regulatory Compliance (PRRC) within their organization — but this is a different requirement from the EC REP. The EC REP is an external EU-based legal representative required specifically for non-EU manufacturers. The PRRC is an internal compliance person (can be contracted) responsible for the broader quality and regulatory system. Non-EU manufacturers who contract a PRRC service are not exempt from the EC REP requirement — both are mandatory.

Frequently asked questions

Is an EU MDR Authorized Representative mandatory?: Yes. Any manufacturer established outside the EU/EEA must appoint an EU MDR Authorized Representative (EC REP) before placing a CE-marked medical device on the EU market.
What does the EC REP do on my behalf?: The EC REP acts as your legal point of contact for EU competent authorities and notified bodies. They register in EUDAMED, receive official correspondence, and can initiate field safety corrective actions on your behalf.
Can one EC REP cover multiple device families?: Yes. Most EC REPs offer portfolio-based pricing that covers multiple device families and legal entities under a single mandate, which is usually more cost-effective.
How long does the appointment process take?: Typically 5–15 business days depending on dossier readiness and the complexity of your device portfolio. Rush onboarding may be available from some providers.
What is the difference between EC REP and a Notified Body?: A Notified Body assesses conformity and issues CE certificates. An EC REP is your legal representative in the EU market — they do not certify your device but are required alongside CE marking for non-EU manufacturers.

How Cruxi Bridge vets providers

✓ Every provider submits regulatory expertise evidence and jurisdictional coverage claims
✓ Providers that go live agree to the Cruxi Bridge Provider Terms including service delivery and accuracy obligations
✓ Payment is held by Cruxi and only released to the provider after service delivery milestones
✓ Buyers can raise a dispute within 30 days — Cruxi reviews and mediates per the platform terms

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