Are EC REP prices publicly comparable?

Usually not. The providers reviewed on 20 August 2026 did not publish a directly comparable standard tariff for the same scope. Compare itemised quotes covering the legal entity, generic device groups, documentation review, EUDAMED work, vigilance support, incident handling, termination and insurance.

Does the EC REP's PRRC satisfy the manufacturer's PRRC obligation?

Not automatically. MDR and IVDR Article 15 impose separate PRRC duties on the manufacturer and on the authorised representative. A micro or small manufacturer may contract a qualified external PRRC, but this must be an explicit, continuously available arrangement rather than an assumed benefit of the EC REP mandate.

Can one provider cover the EU, UK and Switzerland?

A provider group may offer all three services, but the mandates must be accepted by appropriately established legal entities: an EU EC REP, a UK Responsible Person and a Swiss authorised representative. Verify the contracting entity for every territory.

How long does it take to appoint an EU Authorized Representative?

EU law does not set a standard onboarding time. Timing depends on due diligence, technical-documentation review, mandate negotiation and EUDAMED actor validation. The written mandate must be effective before a non-EU manufacturer places the covered device on the Union market.

EC REP Comparison

Compare EU Authorized Representative Providers (2026)

Q: What is an EU Authorized Representative (EC REP)?

An EC REP is a natural or legal person established in the EU that accepts a written mandate from a non-EU medical-device or IVD manufacturer under MDR or IVDR Article 11. The manufacturer retains its own obligations; the EC REP performs the tasks assigned by the Regulation and mandate.

Q: What liability does an EC REP carry?

Under MDR and IVDR Article 11(5), where the manufacturer has not complied with specified Article 10 obligations, the authorised representative can be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.

Compare what can be verified publicly, then use an itemised quote and written mandate to check the details that provider websites rarely disclose: exact scope, service levels, insurance, termination support and total annual cost.

EC REP Cost Calculator →

This is a non-exhaustive shortlist, last checked on 20 August 2026. Inclusion is not a ranking or endorsement. Public pages confirm that each organisation offers EC REP services for medical devices or IVDs; prices, insurance limits and contractual response times require a current written quote.

Provider	EU EC REP evidence	Other public representation services	Public price	Verify in the quote
Emergo by UL	Current EC REP service page	Separate public pages for UK Responsible Person and Swiss CH-REP services	Quote required	Contracting entity, covered generic device groups, review depth, incident support, insurance and exit fees
Obelis Group	Current medical-device representation page	Publicly lists EC REP, UK RP and CH-REP through the group	Quote required	Separate legal entity and mandate per market, registration fees, vigilance work, service levels and insurance
MDSS	Current EC REP page; SRN published	Publicly lists separate UKRP and Swiss CH-REP entities	Quote required	Scope of document review, registration work, response SLA, PRRC arrangement, insurance and termination support

Verification date: 20 August 2026. Provider claims can change. Confirm the legal entity and its EUDAMED Actor ID/SRN before signing; do not treat a brand-level service page as proof that one entity can legally cover every territory.

What to look for when comparing EC REP providers

Five checks matter more than a headline annual fee: legal identity, mandate scope, regulatory competence, operational service levels and financial protection.

1. Compare the same scope — Ask for an itemised quote covering the same generic device groups, risk classes, document-review depth, EUDAMED work, vigilance support, authority requests, annual renewals and termination assistance. A lower base fee is not comparable if essential work is billed separately.

2. Verify the contracting entity — The EU, Great Britain and Switzerland require representatives established in their respective jurisdictions. A group may sell a bundled service, but each mandate must identify the legal entity that performs the local role.

3. Keep the two PRRC duties separate — MDR/IVDR Article 15 applies independently to manufacturers and authorised representatives. The EC REP must have its own qualified PRRC available; that person does not automatically become the manufacturer's PRRC. A micro or small manufacturer may use an external PRRC, but the arrangement must be explicit and continuously available.

What is an EU Authorized Representative (EC REP)?

An EU Authorized Representative (EC REP) is a natural or legal person established in the EU that accepts a written mandate from a non-EU manufacturer under MDR or IVDR Article 11. The manufacturer's obligations remain with the manufacturer; the EC REP performs the regulatory tasks assigned by Article 11 and the mandate. Since 28 May 2026, the EUDAMED Actor module is mandatory, so verify the prospective EC REP's Actor ID/SRN in addition to its company registration and mandate details.

Flat fee vs per-device: which model is cheaper for small manufacturers?

There is no official EU price index for EC REP services, and the reviewed providers do not publish directly comparable standard tariffs. Per-device pricing may suit a small portfolio, while a flat or tiered fee may suit several generic device groups, but the crossover point depends on what each provider counts as a device and which tasks are included. Compare at least two itemised quotes using the same scope.

Do I need a PRRC as part of my EC REP service?

Manufacturers and authorised representatives have separate Article 15 obligations. Manufacturers other than micro and small enterprises must have at least one qualified PRRC within their organisation; micro and small enterprises may instead have one permanently and continuously at their disposal. An authorised representative must independently have at least one qualified PRRC permanently and continuously at its disposal. If a provider offers an external manufacturer-PRRC service, document it separately from the EC REP mandate and verify qualifications, availability, scope and conflicts.

Can one EC REP cover EU, UK and Switzerland?

A provider group can offer all three services commercially, but the legal roles remain separate. The EU mandate must be accepted by an EU-established EC REP, Great Britain requires a UK Responsible Person, and Switzerland requires a Swiss-established authorised representative. Check the full legal name, address and registration of the entity named in each mandate.

How long does it take to appoint an EC REP?

EU law sets no standard onboarding duration. Timing depends on due diligence, technical-documentation review, agreement of the mandate, EUDAMED actor checks and any remediation the provider requires. The written mandate must be effective before a non-EU manufacturer places the covered device on the Union market, so obtain a provider-specific onboarding plan and do not rely on a generic marketing estimate.

What liability does an EC REP carry?

Under MDR and IVDR Article 11(5), where a manufacturer has not complied with specified Article 10 obligations, the authorised representative can be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. Request current insurance certificates, policy limits, exclusions, territorial scope and confirmation that the policy covers the legal entity accepting your mandate.

Broader comparison criteria: additional service coverage

Not all EC REP providers cover the same scope. When comparing providers, also consider whether they offer these additional representative and compliance services — which many non-EU manufacturers require alongside EU AR:

Criterion	Description	Why it matters
Manufacturer PRRC support	A separate Article 15 arrangement where outsourcing is legally available	The EC REP's own PRRC does not automatically satisfy the manufacturer's duty
GPSR Responsible Person	Required for general consumer products under GPSR 2023/988	Separate role from EC REP; some providers bundle both
UK Representative	UK Responsible Person for UKCA-marked products on GB market	Post-Brexit requirement — confirm UK entity exists if needed
Swiss coverage	Swiss Authorized Representative for Swiss market	Separate CH REP required — check affiliated entity
GDPR Art. 27	EU data protection representative	Required if processing EU personal data without EU establishment
DSA Art. 13	EU legal representative for digital service providers	Required for non-EU platforms/marketplaces serving EU users
REACH Only Representative	ECHA registration and SDS management for chemicals	Required for non-EU chemical substance manufacturers
VAT Fiscal Representative	EU VAT registration in member states	Required for non-EU businesses with VAT registration obligations
WEEE/EPR Compliance	National WEEE registry registration and EPR obligations	Required for electronics and packaging producers entering EU
Cosmetics Responsible Person	EU Cosmetics RP under Regulation 1223/2009	Required for non-EU cosmetics brands

Not all providers cover all roles. If you need multiple representative types (e.g., EC REP + PRRC + UK RP), submit a single request on ECP specifying all required services — you will receive proposals from providers matching your full scope rather than having to manage multiple separate searches.

Regulatory sources checked 20 August 2026: MDR Articles 11 and 15, European Commission EUDAMED Actor registration, and MDCG 2022-16 guidance on authorised representatives. Provider capabilities are linked directly in the comparison table.

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