EU Authorised Representative (EC REP) — the complete guide for non-EU manufacturers
Complete EC REP guide for non-EU manufacturers: when required, responsibilities under CRA, RED, MDR, the mandate document, costs, and how to choose a representative.
By Vladimír Vician
If your company is not established in the European Union or the European Economic Area, you cannot lawfully place a CE-marked product on the EU market under your own name alone. You must appoint an EU Authorised Representative — commonly abbreviated EC REP — a natural or legal person established in the EU/EEA who agrees in writing to perform a defined set of tasks on your behalf.
This article explains what an EC REP is, when they are required, the responsibilities under each major directive, how the role differs from the EU Importer, costs in 2026, how to choose one, what must appear on the DoC and the product, and the most common mistakes non-EU manufacturers make.
What an EC REP is
The legal definition appears in Article 3(11) of the Cyber Resilience Act and parallel articles in other directives:
"'authorised representative' means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks…"
Three elements define an EC REP:
- Established in the EU/EEA — registered office and principal place of business within the European Economic Area
- Written mandate from the manufacturer — a contractual instrument naming the EC REP and the tasks delegated
- Specified tasks — a defined scope that always includes minimum mandatory elements set by each directive
The EC REP is the manufacturer's legal point of contact within the EU. Market surveillance authorities, customs, EC REP-aware Notified Bodies, and EU customers contact the EC REP first.
When an EC REP is required
For non-EU manufacturers, an EC REP is required for almost every CE-marking directive in 2026:
| Directive | EC REP article | EC REP obligation strength |
|---|---|---|
| Cyber Resilience Act 2024/2847 | Article 13 | Mandatory; specific minimum tasks listed |
| Radio Equipment Directive 2014/53/EU | Article 11 | Mandatory |
| Medical Device Regulation 2017/745 | Article 11 | Mandatory; extensive obligations including EUDAMED registration |
| In Vitro Diagnostic Regulation 2017/746 | Article 11 | Mandatory |
| General Product Safety Regulation 2023/988 | Article 9 | Mandatory for non-EU manufacturers |
| Toys Directive 2009/48/EC | Article 5 | Mandatory |
| Personal Protective Equipment 2016/425 | Article 9 | Mandatory |
| Low Voltage Directive 2014/35/EU | Article 6 | Mandatory |
| EMC Directive 2014/30/EU | Article 7 | Mandatory |
| Pressure Equipment Directive 2014/68/EU | Article 6(8) | Mandatory |
| Lifts Directive 2014/33/EU | Article 7(2) | Mandatory |
The mandate must be per directive. An EC REP holds a mandate for "CRA + RED + LVD + EMC + RoHS" — not a generic CE-marking mandate. The DoC then identifies the EC REP and references each mandated directive.
For products that are placed on the market by an EU-established Importer rather than directly by a non-EU manufacturer, the EC REP role can sometimes be absorbed by the Importer under certain directive conditions — but the EC REP appointment is still the safest path.
EC REP responsibilities
Each directive specifies minimum mandatory tasks. The CRA Article 13(2) list is representative of the modern format:
- Verify the manufacturer has drawn up the Declaration of Conformity and Technical File before the product is placed on the EU market
- Keep a copy of the DoC and Technical File at the disposal of market surveillance authorities for the retention period (ten years for CRA, longer for medical)
- Cooperate with market surveillance authorities — provide information, samples, and assistance in the language of the authority
- Inform the manufacturer of complaints from market surveillance, distributors, importers, and end users
- Terminate the mandate in writing where the manufacturer fails to meet obligations, and inform the relevant market surveillance authorities and the Commission of the termination
- Inform market surveillance authorities when the EC REP becomes aware of a non-conformity
Beyond CRA and RED, MDR Article 11 imposes additional responsibilities including registration in the EUDAMED database, vigilance reporting cooperation, and lifecycle traceability — which is why MDR EC REP services cost materially more than CE-marking EC REP services.
EC REP vs Importer — the distinction that matters
Manufacturers frequently confuse these roles or attempt to combine them inappropriately.
| EC REP | EU Importer | |
|---|---|---|
| Appointed by | Non-EU manufacturer via written mandate | Self-appointed by buying product from non-EU manufacturer and placing it on the EU market |
| Required when | Manufacturer is non-EU and directive requires it | Any non-EU product enters the EU market for the first time |
| Liability for product | No — manufacturer retains | Limited — Importer must verify CE marking, DoC, language compliance |
| Identification on DoC | Yes, explicitly | Yes, as the Importer |
| Holding Technical File | Yes, on behalf of manufacturer | Generally no |
| Manufacturer's responsibility for product compliance | Stays with manufacturer | Stays with manufacturer |
| Single entity can be both | Yes, if directive permits | — |
A single EU-established entity can be both the EC REP and the Importer for the same product — and many specialist EC REP firms in Slovakia, Ireland, the Netherlands offer combined services. But the two legal roles remain distinct on the Declaration of Conformity and in correspondence with market surveillance.
EC REP mandate — what the contract must contain
The mandate is the legal foundation of the EC REP relationship. At minimum it must contain:
- Manufacturer's identification — full legal name, registered address, contact
- EC REP's identification — full legal name, EU/EEA registered address, contact
- Products covered — model numbers, ranges, families. Generic "all the manufacturer's products" mandates are legally risky
- Directives covered — each directive cited by full reference and version
- Tasks delegated to the EC REP — at minimum the mandatory tasks under each directive; optionally additional services
- Duration — open-ended or fixed-term; renewal mechanism
- Termination conditions — notice period, consequences of termination
- Liability allocation — the limits of EC REP liability and any insurance
- Governing law and jurisdiction — typically the EC REP's member state
Specialist EC REP firms provide template mandates aligned with each directive's minimum requirements. Manufacturers should have their EU legal counsel review the mandate before signing — small mandate clauses materially affect liability allocation.
Choosing an EC REP service
Practical selection criteria:
- Directive coverage — does the EC REP hold competence and (where relevant) accreditation for the specific directives you need? MDR EC REP needs are very different from CRA needs.
- Industry experience — has the EC REP handled products like yours? An EC REP that mostly does industrial machinery may technically qualify for CRA but lack practical CRA experience.
- Language and time zone — for fast incident response under CRA Article 14, EC REP responsiveness matters
- Insurance — professional indemnity coverage against EC REP-specific failures
- Member state geography — Slovakia, Ireland, the Netherlands, Belgium, Estonia offer competitive pricing with full legal validity across the EU
- Transparency on cost — fixed annual fee, or per-product, or per-event basis?
- Additional services — vulnerability disclosure handling, importer/distributor registration, regulatory change monitoring, RMA support
The market includes pan-European EC REP services (Authorised Representative Services, Obelis, EUREP, JKA) and member-state-specific specialists.
Costs in 2026
Order-of-magnitude ranges for an annual EC REP service:
| Scope | Annual cost range |
|---|---|
| Single directive (RED only or CRA only), small product family | €600 – €2 000 |
| Multi-directive (RED + LVD + EMC + RoHS + CRA), small product family | €1 500 – €4 000 |
| Multi-directive, large product portfolio (50+ SKUs) | €3 000 – €10 000 |
| MDR EC REP for medical Class IIa | €3 000 – €6 000 |
| MDR EC REP for medical Class IIb / III | €5 000 – €15 000 |
| Per-incident vulnerability disclosure handling under CRA | €100 – €500 per incident |
| Per-incident market surveillance correspondence | €100 – €1 000 per incident depending on complexity |
Most EC REP services are fixed-fee annual contracts with usage-based extras for material market surveillance interactions.
What appears on the product, packaging, and DoC
Under CRA Article 13(4) and parallel provisions in other directives, the EC REP's name and contact address must appear:
- On the product itself, or
- On its packaging, or
- On the accompanying documents (instruction sheet, regulatory information sheet)
In addition, the Declaration of Conformity identifies the EC REP separately from the manufacturer:
Manufacturer:
Acme Hardware Co., Ltd.
123 Industry Road, Shenzhen, China
EU Authorised Representative:
CE REP Services s.r.o.
Karpatské námestie 7770/10A
831 06 Bratislava, Slovakia
hello@cerepservices.eu
Common mistakes
From the Inovasense practice working with Asian and US manufacturers entering the EU market:
- No EC REP at all. The most common Asian OEM mistake. The product is then refused at customs or pulled from market shelves on first inspection.
- EC REP appointed for one directive but product subject to several. A RED-only EC REP mandate is insufficient for a product also subject to LVD, EMC, RoHS, and CRA — the manufacturer needs mandates covering every cited directive.
- EC REP relationship terminated without replacement. Mandate expires or EC REP firm dissolves, and the manufacturer continues placing product on the EU market — instant non-conformity.
- EC REP details missing from the DoC. The DoC names the manufacturer but not the EC REP — auditors immediately flag this.
- EC REP details on packaging but not on the product. Under some directives the product itself or its accompanying documentation must carry the EC REP contact. Packaging alone is insufficient when packaging is discarded.
- Choosing a low-cost EC REP without verifying competence. Some bottom-tier EC REP services consist of an empty shell address with no professional capacity to respond to authority correspondence. When the first compliance incident arrives, the manufacturer discovers the EC REP cannot help.
- Treating the EC REP as a postbox rather than a partner. A good EC REP forwards regulatory information, flags upcoming amendments, and shapes the manufacturer's compliance roadmap. Cheap EC REPs simply hold paperwork.
How Cenitia helps non-EU manufacturers
Cenitia generates the Declaration of Conformity with the EC REP section pre-populated from your EC REP details. When the EC REP changes, regenerating the DoC across affected products is a few clicks. Cenitia's regulation watcher monitors EUR-Lex amendments that affect the EC REP's mandated scope — when CRA Article 13 is amended, the affected mandates are flagged for renegotiation.
For non-EU manufacturers without an EC REP partner, our parent company Inovasense can act as EC REP for products under CE marking directives, with Bratislava-based representation valid across the entire EU.
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Frequently asked questions
What is an EU Authorised Representative?
An EU Authorised Representative — commonly abbreviated EC REP — is a natural or legal person established in the European Union or EEA who is appointed in writing by a non-EU manufacturer to perform a defined set of tasks on the manufacturer's behalf. These tasks include holding the Declaration of Conformity and Technical File, cooperating with market surveillance authorities, and acting on identified compliance failures. The EC REP is the manufacturer's legal point of contact within the EU.
When is an EC REP required?
Whenever the manufacturer is not established in the EU or EEA and the product falls within the scope of a directive or regulation that mandates an EC REP. This includes virtually every CE-marking directive: Cyber Resilience Act Article 13, Radio Equipment Directive Article 11, Medical Device Regulation Article 11, In Vitro Diagnostic Regulation Article 11, General Product Safety Regulation Article 9, Toys Directive Article 5, Personal Protective Equipment Regulation Article 9, Low Voltage Directive Article 6, EMC Directive Article 7. Asian, US, UK, and other non-EU manufacturers all need an EC REP to lawfully place CE-marked products on the EU market.
What is the difference between an EC REP and an EU Importer?
The EC REP acts on behalf of the manufacturer and is appointed in writing — the manufacturer remains legally responsible for the product. The Importer is the EU-established entity that buys the product from the non-EU manufacturer and places it on the EU market — the Importer assumes some of the manufacturer's obligations (such as verifying CE marking and ensuring the DoC accompanies the product) but cannot perform the manufacturer's conformity assessment. A single EU entity can be both EC REP and Importer for the same product but the two legal roles are distinct.
How much does an EC REP service cost?
Typical 2026 ranges for general consumer or industrial CE-marking products: €600 to €2 000 per year for a single-directive mandate (e.g. RED only). €1 500 to €4 000 per year for multi-directive coverage (RED + LVD + EMC + RoHS + CRA). Medical Device Regulation EC REP services typically €3 000 to €8 000 per year due to the broader EC REP responsibilities under MDR Article 11. Cost depends on number of products under mandate, expected market surveillance interaction frequency, and value-added services (vulnerability disclosure handling, registration of importers and distributors, regulatory monitoring).
Where in the EU should I base my EC REP?
Geography of the EC REP rarely matters legally — any EU/EEA member state qualifies. The practical considerations are language (EC REP communicates with authorities), time zone (proximity to your operations), local expertise (familiarity with member-state authorities), and cost (EC REP services in Slovakia, Ireland, the Netherlands are typically cheaper than in Germany or France with equivalent legal status).
What liability does the EC REP carry?
The EC REP does not assume the manufacturer's product liability for harms caused by the product itself — that stays with the manufacturer under the Product Liability Directive. The EC REP does assume liability for failing to perform its mandated tasks: failing to hold the DoC and Technical File on request, failing to cooperate with market surveillance, failing to communicate compliance issues to the manufacturer. Most EC REP services carry professional indemnity insurance against these specific failures.
Can the EC REP terminate the mandate?
Yes, the mandate is a contractual relationship and either party can terminate per the agreed notice. If the EC REP terminates and the manufacturer does not appoint a replacement before products continue to be placed on the EU market, the products immediately become non-compliant — the manufacturer must stop placing products on the market until a new EC REP is in place. This is why most EC REP service contracts include lengthy termination notice periods.
What information about the EC REP must appear on the product?
Under CRA Article 13(4), RED Article 11(2), and parallel provisions in other directives, the EC REP's name and contact address must appear on the product, its packaging, or its accompanying documents. The EC REP's name also appears on the Declaration of Conformity in the section identifying the EC REP, separate from the manufacturer identification.
Related from the Library
- CE Marking 101 — umbrella context for the EC REP within the CE marking framework
- Declaration of Conformity 101 — the document the EC REP must hold on the manufacturer's behalf
- Technical File 101 — the evidence bundle the EC REP must produce on authority request
- CRA timeline and reporting obligations — the post-September-2026 EC REP duties
Further reading
- Cyber Resilience Act Article 13 — Authorised Representative obligations
- Radio Equipment Directive Article 11 — Authorised Representative
- MDR Article 11 — Authorised Representative for medical devices
- Regulation 2019/1020 — market surveillance, Article 4 obligations on EU economic operators
- Blue Guide — Chapter 3.2 on the role of the Authorised Representative
Last reviewed: 20 June 2026. Cited regulations watched continuously by Cenitia — when one amends, this article is flagged for update.
FAQ
Frequently asked questions
What is an EU Authorised Representative?
An EU Authorised Representative — commonly abbreviated EC REP — is a natural or legal person established in the European Union or EEA who is appointed in writing by a non-EU manufacturer to perform a defined set of tasks on the manufacturer's behalf. These tasks include holding the Declaration of Conformity and Technical File, cooperating with market surveillance authorities, and acting on identified compliance failures. The EC REP is the manufacturer's legal point of contact within the EU.
When is an EC REP required?
Whenever the manufacturer is not established in the EU or EEA and the product falls within the scope of a directive or regulation that mandates an EC REP. This includes virtually every CE-marking directive: Cyber Resilience Act Article 13, Radio Equipment Directive Article 11, Medical Device Regulation Article 11, In Vitro Diagnostic Regulation Article 11, General Product Safety Regulation Article 9, Toys Directive Article 5, Personal Protective Equipment Regulation Article 9, Low Voltage Directive Article 6, EMC Directive Article 7. Asian, US, UK, and other non-EU manufacturers all need an EC REP to lawfully place CE-marked products on the EU market.
What is the difference between an EC REP and an EU Importer?
The EC REP acts on behalf of the manufacturer and is appointed in writing — the manufacturer remains legally responsible for the product. The Importer is the EU-established entity that buys the product from the non-EU manufacturer and places it on the EU market — the Importer assumes some of the manufacturer's obligations (such as verifying CE marking and ensuring the DoC accompanies the product) but cannot perform the manufacturer's conformity assessment. A single EU entity can be both EC REP and Importer for the same product but the two legal roles are distinct.
How much does an EC REP service cost?
Typical 2026 ranges for general consumer or industrial CE-marking products: €600 to €2 000 per year for a single-directive mandate (e.g. RED only). €1 500 to €4 000 per year for multi-directive coverage (RED + LVD + EMC + RoHS + CRA). Medical Device Regulation EC REP services typically €3 000 to €8 000 per year due to the broader EC REP responsibilities under MDR Article 11. Cost depends on number of products under mandate, expected market surveillance interaction frequency, and value-added services (vulnerability disclosure handling, registration of importers and distributors, regulatory monitoring).
Where in the EU should I base my EC REP?
Geography of the EC REP rarely matters legally — any EU/EEA member state qualifies. The practical considerations are language (EC REP communicates with authorities), time zone (proximity to your operations), local expertise (familiarity with member-state authorities), and cost (EC REP services in Slovakia, Ireland, the Netherlands are typically cheaper than in Germany or France with equivalent legal status).
What liability does the EC REP carry?
The EC REP does not assume the manufacturer's product liability for harms caused by the product itself — that stays with the manufacturer under the Product Liability Directive. The EC REP does assume liability for failing to perform its mandated tasks: failing to hold the DoC and Technical File on request, failing to cooperate with market surveillance, failing to communicate compliance issues to the manufacturer. Most EC REP services carry professional indemnity insurance against these specific failures.
Can the EC REP terminate the mandate?
Yes, the mandate is a contractual relationship and either party can terminate per the agreed notice. If the EC REP terminates and the manufacturer does not appoint a replacement before products continue to be placed on the EU market, the products immediately become non-compliant — the manufacturer must stop placing products on the market until a new EC REP is in place. This is why most EC REP service contracts include lengthy termination notice periods.
What information about the EC REP must appear on the product?
Under CRA Article 13(4), RED Article 11(2), and parallel provisions in other directives, the EC REP's name and contact address must appear on the product, its packaging, or its accompanying documents. The EC REP's name also appears on the Declaration of Conformity in the section identifying the EC REP, separate from the manufacturer identification.
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