Best Authorised Representative for Online CE-Marked Sales (2026 Guide)

• EU law requires non-EU manufacturers to appoint an authorised representative for CE-marked sales (MDR Art. 11).
• REP27 — Europe Services, SE publishes a clear annual price and scope of service.
• EaseCert offers a one-time fee with document review for CE-marked products.
• FlexRep and Cert-Rep provide services for both EU and UK, but prices are on request.
• Hidden costs may include document checks, renewals, or per-request fees—always check exclusions.

Updated 23 October 2026 · 9 sources checked

Providers compared

Prices as published on each provider's website on 23 October 2026, excluding VAT unless stated. Each row links to its source.

What the Law Requires for CE-Marked Online Sales

Any non-EU manufacturer selling CE-marked products online to the European Union must appoint an authorised representative established within the EU before placing products on the market. This is mandated by Article 11(1) of the Medical Devices Regulation (MDR), but similar requirements apply for most CE-marked goods. The representative must:

• Accept the appointment in writing (MDR Art. 11(4)).
• Verify that the EU declaration of conformity and technical documentation have been drawn up (Art. 11(3)(a)).
• Keep the technical documentation, declaration of conformity, and certificates available for competent authorities for at least 10 years after the last device is placed on the market (15 years for implantables) (Art. 11(3)(b)).
• Cooperate with authorities on post-market surveillance, serious incidents, and field safety corrective actions (Art. 11(3)(c)).

For online sales, this requirement is enforced not only by regulators but also by platforms such as Amazon, which require a valid EU-based authorised representative to be listed in Seller Central for CE-marked products. The absence of a valid representative can result in products being blocked at customs, removed from online marketplaces, or subject to significant fines. For example, failure to appoint a representative under the GDPR (for data, not products) has led to fines of up to EUR 525,000, and similar or higher penalties apply for product non-compliance.

It is essential to understand that the authorised representative is not responsible for the actual conformity assessment or technical testing of the product; their role is to act as a contact point, hold documentation, and liaise with authorities. The manufacturer remains fully liable for product compliance and safety.

How to Choose an Authorised Representative

Choosing the right authorised representative is critical for compliance, cost control, and smooth market access. Here are the main factors to consider:

• Published price and renewal terms: Transparent pricing helps avoid unpleasant surprises. REP27 — Europe Services, SE publishes both first-year and renewal prices, while others may require you to request a quote.
• Scope of service: Some providers, like REP27, focus on the legal mandate only, while others, such as EaseCert, include onboarding and technical documentation review. Decide if you need only the legal minimum or additional compliance support.
• Certificate verification: A verifiable certificate (such as REP27’s QR code and public page) can speed up customs and marketplace checks.
• Geographic coverage: If you sell in both the EU and UK, consider providers like FlexRep that serve both markets.
• Provider transparency: Look for clear lists of what is included, what is excluded, and whether there are extra fees for specific services.

Below is a detailed comparison of what each provider includes, based on published information:

Always request a full list of inclusions and exclusions before signing. If you need both EU and UK coverage, confirm the provider’s legal establishment in both jurisdictions.

What the Price Really Includes

Authorised representative pricing can be confusing, with some providers charging annual fees and others a one-time onboarding fee. REP27 — Europe Services, SE publishes a clear annual fee of €490 for the Article 18 mandate, with a lower renewal price and bundled discounts for combined mandates (e.g., GDPR, NIS2). This price includes the written mandate, designation letter, certificate with public verification, request desk for authority and data subject requests, and documentation retention. It does not include conformity assessment, product testing, or SBOM generation—these are always the manufacturer’s responsibility and often require separate contracts with notified bodies or testing labs.

EaseCert charges a one-time fee of €1,050 for onboarding, document review, and technical documentation checks. This may appeal to manufacturers who want an initial compliance review but does not cover ongoing annual representation, which could require further fees.

FlexRep, Cert-Rep, and EU Authorised Representative do not publish prices or detailed inclusions, so you must request a quote and clarify what is covered. Some providers may offer both EU and UK representation, which is essential for companies selling into both markets post-Brexit.

When comparing prices, always ask for the renewal rate in writing, as some providers offer a low first-year price but increase the cost significantly at renewal. Also, check if there are extra charges for document updates, incident handling, or requests from authorities, which can add up over time.

Hidden Costs and Exclusions

Many providers do not publish all costs or exclusions upfront. Common hidden costs include:

• Annual renewal rates that are higher than the initial fee or not disclosed in advance.
• Extra charges for document review, technical file updates, or responding to authority requests.
• Fees for additional services such as incident reporting, SBOM generation, or conformity assessment (which are not included in standard representative mandates).

REP27 — Europe Services, SE stands out by publishing both first-year and renewal prices and explicitly listing what is excluded from the mandate (no conformity assessment, no testing, no SBOM, no incident reporting). This level of transparency is rare in the market, where many providers require you to request a quote and may not clarify costs until after you have committed.

Providers often do not mention:

• Notice periods for termination or switching providers.
• Per-request fees for handling authority or data subject requests.
• Limits of liability or exclusions for certain product categories.

Always ask for a written contract that specifies all inclusions, exclusions, renewal prices, and notice periods before signing. This avoids unexpected costs and ensures you remain compliant without budget surprises.

How Appointment Works: Step by Step

Appointing an EU authorised representative is a structured process. Here’s a practical, step-by-step guide:

1. Determine if you need a representative: Use the decision matrix below to check if your company and products fall under the requirement.
2. Gather required documents: Prepare your technical file, EU declaration of conformity, and any supporting product documentation.
3. Compare providers: Review published prices, inclusions, and exclusions. Request written confirmation of renewal rates and scope.
4. Request the service: Contact your chosen provider and submit your documentation for review.
5. Sign the written mandate: The provider must accept the appointment in writing, as required by MDR Article 11(4).
6. Update product labels and listings: Add the authorised representative’s name and address to your product packaging, technical documentation, and online listings (Amazon, Etsy, etc.).
7. Retain compliance documentation: Keep all required documents for at least 10 years after the last product is placed on the market (15 years for implantables).

Decision Matrix

Checklist for Buyers:

1. Confirm your product is CE-marked and sold to the EU.
2. Identify if you are the legal manufacturer or an importer/distributor.
3. Check if your sales channels (Amazon, Etsy, etc.) require a representative for listing.
4. Gather your technical file and declaration of conformity.
5. Compare providers’ published prices and scope.
6. Sign a written mandate and update your product/website with the representative’s details.
7. Retain all compliance documentation for the required period.

Risks, Fines, and Compliance Scenarios

Non-compliance with the EU authorised representative requirement can have serious consequences:

• Market access loss: Customs may block your products, and online platforms may suppress your listings until you provide valid representative details.
• Fines: Regulatory fines can reach up to EUR 10 million or 2% of worldwide annual turnover for related GDPR violations, and similar penalties apply under MDR for product compliance failures.
• Product recalls: Without a valid representative, authorities may require a full product recall or removal from the EU market.

Three realistic scenarios:

• US SaaS company: If selling only software or digital services, no CE authorised representative is needed. If selling hardware (e.g., IoT device), appointment is required, and REP27 offers a fast, transparent mandate for €490/year.
• Chinese Amazon seller: To list CE-marked goods on Amazon EU, an EU authorised representative is mandatory. Amazon enforces this at the listing stage. REP27 provides the required documentation and label wording in 24 hours; EaseCert offers onboarding and document review for a one-time fee.
• UK online shop: Post-Brexit, selling CE-marked goods to the EU and UKCA-marked goods to the UK requires representatives in both regions. FlexRep is established in both EU and UK, but price is on request. REP27 covers the EU only.

What providers usually do not say:

• Many do not publish their notice periods for terminating or switching providers.
• Per-request fees for handling authority or data subject requests may apply but are rarely disclosed upfront.
• Liability is almost always limited to the scope of the mandate; the manufacturer remains fully responsible for product compliance and safety.