CE Authorised Representative Services

Why You Need an EU Authorised Representative

To better protect EU consumers and the environment, EU law requires that all CE-marked products placed on the EU market must display the manufacturer’s name and contact address to ensure product traceability. If the manufacturer is based outside the European Economic Area (EEA, which includes the EU and EFTA countries), the product must also indicate the name and contact address of the EU Authorised Representative (AR).

To improve market surveillance efficiency, the European Commission is responsible for monitoring enforcement and ensuring all member states meet minimum legal requirements. The Commission also cooperates with customs authorities and stakeholders (manufacturers, ARs, importers, distributors) to establish a robust product traceability system. High-risk sectors, such as medical devices, are the Commission's top priority.

Definition and Responsibilities of the EU Authorised Representative

An EU Authorised Representative (European Authorised Representative or Authorized Representative)is a natural or legal person located within the EEA, explicitly appointed by a manufacturer based outside the EEA. This representative acts on behalf of the manufacturer to fulfill specific legal obligations required under relevant EU directives and regulations.

Key requirements and responsibilities:

The AR must be established within the EEAand have a commercial address. Some countries may also require a company registration numberor EU VAT number.

National authorities can directly contact the AR to verify the manufacturer’s compliance with EU laws.

A manufacturer’s general commercial representative (such as a distributor), even if based within the EEA, is not equivalentto an Authorised Representative.

The manufacturer remains fully responsiblefor product compliance, even if an AR is appointed.

The AR must not alterthe manufacturer’s products without written consent, even if the changes are meant to ensure compliance with EU requirements.

Why You Must Appoint an EU Authorised Representative

To ensure the safety and complianceof CE-marked products sold in the EU, and to meet legal requirements concerning consumer protection, property, and environmental safety, manufacturers outside the EU must:

1) Appoint an EU Authorised Representative

A non-EU manufacturer must designate an AR based in one of the 30 EEA member countries (EU + EFTA) to handle all CE-related matters with EU authorities.

2) Display AR Information on Packaging

The AR’s name and addressmust be clearly printed on the packaging, labels, and user instructionsof CE-marked products imported into the EU.

3) Technical Files Must Be Held by the AR

The AR must store and updatethe technical documentation for all CE-marked products sold in the EU and make it available to authorities upon request. These records must be retained for at least 5 yearsafter the last batch of products is placed on the market.

4) Establish a Post-Market Surveillance System

Manufacturers must implement a system within the EU for incident monitoring, including reporting, notifications, and recalls, facilitated by the AR.

Why an EU Authorised Representative Is Different from Importers or Distributors

1. Legal Representation:

The AR handles legal CE mattersin the 30 EEA countries—similar to how a lawyer represents a client in court. Distributors/importers focus on sales and often lack the expertise or willingness to manage complex compliance issues.

2. Mandatory Information on Products:

The AR’s details must be printed on the product’s label or packaging, enabling direct communication between EU authorities and the AR.

3. Only One AR Allowed:

EU law permits only one AR per non-EU manufacturer, while multiple distributors or agents may exist. The AR is the sole contact pointfor EU authorities in case of compliance issues.

4. Focus on ce compliance:

While sales agents prioritize revenue, ARs monitor regulatory changes to ensure your products remain compliant.

5. Representation in Critical Incidents:

In case of incidents or investigations, your AR will protect your legal interests before EU regulatory bodies.

6. Neutrality & Confidentiality:

Would you prefer to store your confidential technical documents with a neutral party like JJR, or risk entrusting them to a potential competitor, such as an EU distributor?

7. Avoid Conflicts Between Sales Channels:

If you have many EU distributors but are only allowed one AR, appointing one distributor as your sole AR could cause tension with others. A neutral ARavoids this conflict.

8. Best Practice:

For long-term success, most manufacturers choose independent, professional AR servicesrather than combining representation with distribution.

Our EU Authorised Representative Services

• Product Registration in the EU

We will register your product in accordance with EU requirements and issue a Product Registration Certificate. Certificates are valid for one year and must be renewed annually. Any product changes must be promptly updated in the registration.

• Technical File Storage

We store and maintain the technical documentationof your CE-marked products sold in the EU and ensure it is available for inspection by EU authorities. Files are retained for at least 5 yearsafter the product is discontinued.

• Regulatory Monitoring

We provide timely updates and notifications on any changes in EU legislation relevant to your products.

• Post-Market Surveillance System

We establish an effective incident monitoring systemwithin the EU, assisting with incident reports, alerts, and product recalls.