Alternatives to Using an Authorised Representative for CE-Marked Products

• EU law (Regulation (EU) 2019/1020, Article 4) usually requires a representative.
• Alternatives: appoint an EU-based importer or fulfilment provider as economic operator.
• Direct B2B sales to EU importers may not require a representative.
• Some marketplaces (Amazon, etc.) enforce the authorised representative field.
• Non-compliance risks fines and product removal from the EU market.

Updated 25 October 2026 · 15 sources checked

Providers compared

Prices as published on each provider's website on 25 October 2026, excluding VAT unless stated. Each row links to its source.

What the Law Requires: Article Numbers and Obligations

For CE-marked products, Regulation (EU) 2019/1020, Article 4, is the core legal requirement: non-EU manufacturers must appoint an EU-based economic operator before placing products on the EU market. This economic operator can be an importer, a fulfilment service provider, or an authorised representative. The law is explicit: if you do not have an EU establishment, you must designate one of these options. For medical devices and IVDs, Article 11 of Regulations (EU) 2017/745 and 2017/746 require an EU authorised representative. The General Product Safety Regulation (EU) 2023/988 extends the requirement to most consumer products, demanding a Responsible Person in the EU.

• The authorised representative must be a legal entity established in the EU and act on behalf of the manufacturer (source).
• Their name and address must be clearly visible on the product, its packaging, or accompanying documentation.
• They must hold the manufacturer's technical documentation and make it available to authorities on request.
• They are required to cooperate with authorities, especially in the event of corrective actions or market surveillance activities.
• For medical devices and IVDs, the representative's details must be registered and accessible to authorities.

Failure to comply can result in fines and removal of products from the EU market. For example, non-compliance with the authorised representative requirement has resulted in significant penalties and blocked sales channels. Marketplaces such as Amazon enforce the authorised representative field, making compliance a practical as well as a legal necessity. Ultimately, unless your importer or fulfilment provider is willing and able to act as your economic operator, you must appoint a dedicated authorised representative.

How to Choose: Decision Matrix and Provider Comparison

Choosing the right compliance route depends on your business model, product type, and sales channels. The following decision matrix helps clarify your obligations and options:

When comparing providers, focus on transparency, published pricing, and what is included in the service. For example, REP27 — Europe Services, SE publishes its prices and renewal terms up front, while most competitors require you to request a quote. Consider whether you need additional services such as regulatory updates, support for both EU and UK markets, or consulting for international regulation. Some providers, like Lappa, offer both EU and UK coverage, which may be relevant post-Brexit. Always verify the legal entity, the scope of the mandate, and the process for handling authority requests. Providers that cannot list exclusions or renewal prices may introduce hidden costs or risks. Use the table above to compare providers on these criteria.

What the Price Really Includes: Service Breakdown

Authorised representative services vary in scope and transparency. The annual fee typically covers the legal mandate, documentation retention, and acting as the point of contact for EU authorities. However, conformity assessment, technical testing, and incident reporting are almost never included and remain the manufacturer's responsibility. Below is a comparison of what is included, not included, and may incur extra fees for major providers:

Always request a written list of exclusions before signing. For example, REP27 is explicit that conformity assessment, testing, SBOM generation, and incident reporting are not included, and the price is fixed with no upsells. Many providers do not publish their renewal prices or may charge extra for handling authority requests or providing certificates. When comparing offers, ask for the renewal price in writing and clarify whether the fee covers all EU/EEA countries or only specific Member States. For medical devices and IVDs, ensure the provider is familiar with the requirements of Regulations (EU) 2017/745 and 2017/746.

Hidden Costs and What Providers Usually Do Not Say

Many buyers overlook the potential for hidden costs and exclusions in authorised representative agreements. The most common hidden costs include:

• Conformity assessment and testing: These are never included in representative fees. The cost and responsibility for product testing, technical documentation, and conformity assessment remain with the manufacturer. Notified body assessments, where required, can cost thousands of euros and take months to complete.
• Per-request fees: Some providers charge extra for handling authority inquiries, document updates, or urgent requests. These fees are rarely published up front.
• Silent renewals or increased renewal prices: Many providers do not publish renewal prices, leading to unexpected increases. REP27 is an exception, publishing renewal prices on its site.
• Liability limits: The law (e.g., EUDR Article 6) makes clear that the manufacturer or operator remains liable for compliance, not the representative. Some providers may include contractual liability limitations or notice periods for termination.
• Geographic scope: Some representatives only cover certain EU Member States or charge extra for EEA coverage. Always confirm the geographic scope in writing.

What providers usually do not say: The representative is not a distributor or agent and does not take on commercial or product safety liability. They cannot absorb the cost or responsibility for engineering, documentation, or incident response. No representative can perform conformity assessment or testing, and any suggestion otherwise is misleading. Always ask for a detailed breakdown of what is included, what is excluded, and any circumstances that may trigger extra fees or contract termination.

How Appointment Works: Step-by-Step Checklist

1. Identify your obligations: Determine if your product and sales model require an authorised representative or if an EU-based importer or fulfilment provider can act as your economic operator.
2. Choose a provider: Compare providers based on published prices, transparency, and included services. Verify the legal entity and ensure they are established in the EU.
3. Request and review the mandate: The mandate should specify the relevant article (e.g., Article 18 for the Cyber Resilience Act) and the provider’s responsibilities. Avoid mandates that claim to cover duties forbidden by law (e.g., Article 13 duties under Article 18(2)).
4. Sign the agreement: Both parties sign the written mandate. Some providers, like REP27, offer eIDAS electronic signatures and verifiable certificates.
5. Provide technical documentation: Send your declaration of conformity, technical file, and other required documents to the representative for retention.
6. Update product labeling: Ensure the representative’s name and address appear on your product, packaging, or accompanying documents as required by law.
7. Notify your supply chain: Inform distributors, importers, and marketplaces of your new representative. For Amazon and similar platforms, update the relevant fields in Seller Central or equivalent.
8. Maintain communication: Ensure your representative can reach you in case of authority requests or incidents. Respond promptly to all forwarded requests.
9. Renew the mandate: Track renewal dates and ensure continuous coverage. Confirm the renewal price and process in advance.

This process can be completed in as little as 24 hours with some providers, but technical documentation and product labeling updates may take longer. Always keep records of all agreements and communications for audit purposes.

Risks, Fines, and Realistic Scenarios

Non-compliance with EU authorised representative requirements carries significant risks:

• Fines: Regulatory authorities can impose substantial fines for failure to appoint a representative. For example, under GDPR Article 83(4)(a), fines can reach up to EUR 10 million or 2% of worldwide turnover for failing to designate a representative (see Locatefamily.com case).
• Product removal: Authorities can remove non-compliant products from the EU market, block imports, or suspend sales on major marketplaces like Amazon.
• Procurement delays: Enterprise buyers and distributors may refuse to purchase from non-compliant suppliers, leading to lost sales and longer sales cycles.
• Reputational damage: Non-compliance can harm your brand and relationships with EU partners.

Three realistic scenarios:

• US SaaS company selling only to EU businesses via distributors: If the EU distributor acts as the importer and economic operator, a separate authorised representative may not be needed. However, for direct B2C sales or if the distributor does not assume this role, an authorised representative is required.
• Chinese Amazon seller: Amazon enforces the authorised representative requirement for listings. The seller must appoint a representative, update Seller Central, and ensure the representative’s details are on the product and packaging. Failure to do so results in blocked listings and lost sales.
• UK online shop selling B2C to EU customers: Post-Brexit, the UK is a third country. The shop must appoint an EU authorised representative or use an EU-based fulfilment provider as the economic operator. The representative’s details must be on the product, and technical documentation must be available in the EU.

In all cases, the simplest compliant route is to appoint a reputable authorised representative, ensure all documentation is in order, and update product labeling and marketplace records as required.