EU Authorised Representative Services

An EU Authorised Representative (EU AR) is a company officially designated within the European Union to act on behalf of a manufacturer located outside the EU. Their role is to represent the manufacturer in relation to regulatory responsibilities for products placed on the EU market.

You are required to appoint an EU Authorised Representative if your company is established outside the European Union and you intend to sell products in the EU that are subject to specific European directives or regulations. These may include frameworks such as the General Product Safety Regulation (GPSR), Medical Devices Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), Toy Safety Directive, EMC Directive, Radio Equipment Directive (RED), Low Voltage Directive (LVD), PPE Regulation, Machinery Regulation, Cosmetics Regulation, RoHS Directive, and other applicable EU legislation.

An EU Authorised Representative is generally required for products that fall under EU regulatory controls. Common product groups include:

• Electrical and electronic devices

• Toys and products intended for children

• Cosmetic and beauty items

• Medical devices and in vitro diagnostic products (IVDs)

• Industrial equipment and machinery

• Personal protective equipment (PPE) and safety gear

• Radio equipment, IoT devices, and wireless technologies

• Materials intended for food contact

• General household and consumer products

• Chemical substances and aerosol products

If the applicable EU legislation requires a representative established within the European Union, one must be formally appointed before the product can be legally placed on the EU market.

An EU Authorised Representative (AR) or Responsible Person (RP) is responsible for carrying out key regulatory functions on behalf of a non-EU manufacturer. Their obligations typically include:

• Retaining and managing your technical documentation

• Confirming that the product complies with all relevant regulations before it is placed on the EU market

• Serving as the official point of contact for regulatory authorities

• Supporting and coordinating inspections, compliance checks, and testing requests

• Managing product safety issues, including recalls and required notifications through systems such as SCMS or the Safety Business Gateway (SBG)

• Verifying that product labelling, CE or UKCA markings, and traceability details are accurate and compliant

• Keeping regulatory documentation on file for the legally required retention period, typically between 10 and 15 years depending on the applicable legislation

The requirement to designate an EU Authorised Representative depends on the type of product being placed on the market. Various EU laws and directives may mandate the appointment of a representative established within the European Union, including:

• General Product Safety Regulation (EU 2023/988)

• Toy Safety Directive (2009/48/EC)

• Medical Devices Regulation (EU 2017/745)

• In Vitro Diagnostic Regulation (EU 2017/746)

• Electromagnetic Compatibility (EMC) Directive (2014/30/EU)

• Low Voltage Directive (2014/35/EU)

• Radio Equipment Directive (2014/53/EU)

• Personal Protective Equipment Regulation (EU 2016/425)

• Machinery Regulation (EU 2023/1230)

• Cosmetics Regulation (EC 1223/2009)

• Restriction of Hazardous Substances (RoHS) Directive (2011/65/EU)

• REACH Regulation (EC 1907/2006)

• Food Contact Materials legislation

The specific requirement will depend on your product’s classification and the applicable legal framework.

Euverify provides support across the principal EU and UK compliance regimes to help ensure your products meet all relevant regulatory obligations.

Yes, it is still required.

Selling products online is legally treated in the same way as selling through physical retail channels. E-commerce platforms and online marketplaces typically require a valid EU-based contact address and may request details of your Authorised Representative or Responsible Person, along with relevant certifications, declarations, and product safety documentation before allowing products to remain listed.

The documents needed will vary depending on your product category, but may include:

• Complete technical documentation file

• EU Declaration of Conformity

• Relevant test reports in line with applicable EN or ISO standards

• A documented risk assessment

• Details of your manufacturing process and facility

• Final product label artwork showing the AR/RP address

• Safety Data Sheets (for chemicals or aerosol products)

• Product Information File (PIF) and Cosmetic Product Safety Report (CPSR) for cosmetics

• Regulatory and technical documentation for medical devices

 Complico Consulting provides structured, step-by-step guidance to help you compile and submit the correct documentation for your specific product type.

In most cases, your EU Authorised Representative service is activated within 24 hours once the following steps have been completed:

• Account registration is finalised

• Your company information has been provided

• The digital Authorised Representative agreement has been signed

• All required documentation has been submitted

Once these requirements are met, activation is typically processed within one working day.

Your product labelling will include the following details:

• The EU Authorised Representative address located in Ireland

• The UK Responsible Person address based in England

These addresses are provided exclusively to registered Euverify clients and may be used on your packaging, labelling, and related compliance documentation.

Yes.

All submitted documentation is securely archived for the full legally required retention period, typically between 10 and 15 years depending on the applicable regulation.

Regulatory authorities may request access to these records at any time, and Euverify handles all official correspondence and communication with the relevant authorities on your behalf.

Yes.

Your technical file is carefully evaluated to ensure it is complete, properly structured, and aligned with applicable regulatory requirements. If any information or documentation is missing, this will be highlighted, and clear guidance will be provided on what needs to be corrected or added.

If a regulatory authority makes contact, our compliance specialists will manage the matter on your behalf. This includes:

• Communicating directly with the relevant authority

• Supplying requested technical documentation

• Coordinating and managing compliance or safety verifications

• Advising you on any required corrective measures

• Assisting with product recalls or mandatory incident reporting, where applicable

Throughout the process, you will be kept fully updated and informed of any developments.

Yes.

Euverify can act as your EU Authorised Representative for Class I medical devices and provides support with key regulatory obligations, including:

• EUDAMED registration procedures

• Manufacturer registration requirements

• UDI implementation and product traceability

• Review and verification of technical documentation

• Management of safety-related communications

Dedicated Authorised Representative services for medical and IVD products are available to ensure compliance with the relevant EU regulations.

Yes.

Euverify can act as your Responsible Person for cosmetic products placed on the EU market. Our services include:

• Preparation and review of the Cosmetic Product Safety Report (CPSR)

• Compilation and maintenance of the Product Information File (PIF)

• Submission of product details through the Cosmetic Products Notification Portal (CPNP)

• Compliance review of product labelling

• Management of required safety documentation

• Ongoing post-market surveillance support

We help ensure your cosmetic products meet all regulatory obligations before and after they are made available within the European Union.

CE marking is required for products placed on the European Union market. It indicates that the product complies with applicable EU legislation and regulatory requirements.

UKCA marking (UK Conformity Assessed) is required for products sold in Great Britain (England, Scotland, and Wales). It confirms compliance with relevant UK regulations following Brexit.

Depending on where your products are distributed, you may need one marking or both to legally place your goods on the respective markets.

Euverify provides guidance and support for both EU and UK compliance pathways to help ensure your products meet all applicable requirements.

If you’d like, I can also provide a more technical regulatory explanation or a simple comparison table format for your website.

Can I appoint Euverify solely for the Authorised Representative address without using the platform?

Yes.

Our service is designed to accommodate multiple brands, product categories, and product lines under a single account. This allows you to manage compliance for different product families efficiently through one central arrangement.

You are required to inform us of any changes.

Depending on the nature of the update, it may be necessary to submit revised technical documentation or provide an updated technical file to ensure continued regulatory compliance.

Yes — in fact, this is precisely the purpose of Authorised Representative (AR) and Responsible Person (RP) services.

We work with manufacturers and businesses located outside the European Union, including companies based in the United States, China, Switzerland, the UAE, Australia, India, and many other countries worldwide.

No.

There is no long-term commitment required. You may cancel your subscription at any time, and our services do not include mandatory minimum-term agreements.

Yes.

Euverify provides support with product recall procedures and notifications through the Safety Gate (formerly known as RAPEX), helping ensure regulatory obligations are properly met.

You can choose the level of service that suits your business needs:

• EU Authorised Representative service only

• Combined EU and UK compliance support (recommended for brands operating internationally)

We help guide you through the required steps and manage communications where necessary to maintain compliance.

Euverify provides AR support across a broad range of regulated industries, including:

• Consumer goods

• Electrical and electronic products

• Toys and children’s items

• Cosmetic and beauty products

• Medical devices

• Personal protective equipment (PPE)

• Food-contact materials

• Machinery and mechanical equipment

• DIY products and tools

• Sports and outdoor equipment

• Household goods

• Industrial machinery and equipment

Our services are designed to accommodate diverse product categories while ensuring compliance with applicable EU and UK regulations.

Yes.

As part of our service, you are permitted to display our EU or UK address on your product packaging and labelling, where required by applicable regulations. This ensures your products include the legally mandated local contact details when placed on the relevant market.

All documentation is protected through encryption and stored within secure systems located in the European Union.

Access to files is strictly limited to authorised personnel only, ensuring controlled and secure handling of sensitive information.

Complico Consulting operates in full compliance with the requirements of the General Data Protection Regulation (GDPR), maintaining high standards of data privacy and security at all times.