Authorized representative
services in EU and UK
Lovat provides an authorised representative services in the EU and UK with clear terms and expert guidance with 24/7 support. We ensure quick and seamless access to these markets and step by step assistance.
Who requires an EU/UK Responsible Person service
Since July 16, 2021, EU regulations mandate that manufacturers of CE-marked products made outside the EEA appoint an Authorized representative to ensure compliance.
- Specific Products: Toys, measuring instruments, mobile devices and other categories require an EU authorised representative for compliance.
- Marketplace rules : Platforms like Amazon, eBay, and Etsy may also demand a local address for other product categories for product listing
- Mandatory labelling : The CE or UKCE marking must be on the packaging, documentation or product with an authorized representative adress provided.
Get a free advice on whether you require an Authorized Representative in the EU or UK, just fill out this form. Simply complete our short form or request a consultation with our experts on any question that has arisen.
Why use an authorized representative
The presence of a European- authorised representative service.enables the manufacturer to delegate part of his duties. It’s the representative who will provide the link between the manufacturer and the authority in order to organize the safe and legal sale of your product. This service allows you to quickly enter the desired market, regardless of the type of business. An authorized representative accommodates his services to the needs of a particular brand.
Our role as authorized representatives
Lovat acts as your dedicated authorised representative for EU and UK. Our monthly subscription of €80 provides you with all the essentials for placing your products on the market, communication with local authorities. As authorised representatives, we also support clients with documentation, labelling and access to exclusive offers through their account manage
Your EU and UK compliance package includes:
- Legal Address: Use of our EU address for product labeling to meet regulations.
- Documentation Review: Thorough checks of your EU declaration, technical files, and quality system.
- Product Registration: Assistance with initial and updated registrations in the electronic system.
- Authority Communication: Support with competent authorities, complaints, and incident reporting.
- Regulatory Updates: Notifications of changes affecting your devices and registrations.
- File Storage: Secure 10-year document storage and technical file maintenance.
- Market Surveillance: Response to requests from market authorities.
Onboarding process for Authorised Representative service includes:
We designed a clear onboarding process for the authorised representative (AR) service to make sure compliance is smooth, transparent and efficient. Below are the steps you will go through as our client:
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Document checklist – we provide you with a full list of documents required to start the process together with an authorised representative contract template.
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Payment – secure the service with the agreed subscription fee.
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AR details for labelling – you receive full AR contact details to create your product label mock-ups.
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Document upload & verification – you upload documents, and our experts check for completeness and authenticity. If something needs adjustments, we provide detailed guidance.
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Important: test reports must be issued for the specific product batch and not older than three months before contract signing. We can also recommend accredited laboratories in your country.
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Contract signature – after successful document verification, the AR contract is sent for your signature via DocuSign.
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Finalisation – once signed by you, the contract is countersigned by our representative.
Transferring an Authorized Representative (AR) in EU and UK
Transferring an Authorised Representative (AR) in the context of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) involves several key steps, as per Article 12:
- Update product labelling: Manufacturers must revise labels to include the new authorised representative.
- Document the transfer: It’s essential to clearly define and document the end date of the agreement with the previous authorised representative and the start date with the new authorised representative. All relevant documentation should be updated accordingly to reflect this change.
- Forward complaints: Manufacturers must arrange for the outgoing authorised representative to forward any complaints from healthcare professionals, users, or patients concerning devices released to the market before the authorised representative transfer date to either the manufacturer or the new authorised representative.
- Formalise the agreement: Ideally, the details of this transfer, including responsibilities and timelines, should be outlined in a formal Agreement signed by the manufacturer, the outgoing authorised representative, and the incoming authorised representative.
CE Label and authorised representative requirements for Products in the EU and UK
The CE marking is a mandatory conformity mark for certain products sold within the European Economic Area (EEA).For manufacturers outside the EEA, appointing an authorised representative service in the EU or UK is often a requirement for CE or UKCA compliance and product market access.It certifies that a product complies with the EU’s health, safety, and environmental protection standards outlined in directives and regulations.
Key Requirements:
- Product Categories: CE marking applies to a wide range of products, including electronics, machinery, medical devices, and more.
- Documentation: Manufacturers must prepare technical documentation and a Declaration of Conformity (DoC) to demonstrate compliance with applicable requirements.
- Testing: Depending on the product category and risk level:
- Manufacturers may self-declare compliance.
- In some cases, testing by a notified body is required to confirm compliance with EU standards.
- Enforcement: Non-compliance can result in fines, product recalls, or bans on sales within the EEA. An authorised representative ensures obligations are fulfilled
CE Marking and Brexit: New UK Rules
Since Brexit, the UK has introduced its own marking system, UKCA (UK Conformity Assessed), for products sold in Great Britain.
- Since Brexit, the UK has introduced UKCA (UK Conformity Assessed) marking for products in Great Britain. Government guidance confirms that CE marking will continue to be accepted indefinitely for most product categories, while UKCA remains optional. Businesses may use either CE or UKCA, but appointing a UK authorised representative or Responsible Person is still required for many industries.
For assistance in ensuring CE or UKCA compliance for your products, and to appoint an authorised representative service in the EU or UK , contact us to streamline the process and meet regulatory requirements.
EU Authorized Representative for Amazon Sellers
Understanding the differences between CE and UKCA marking is crucial for businesses selling in the EU and UK. Both systems require an authorised representative service if the manufacturer is based outside the region. The table below shows how the two conformity marks compare across key criteria.
| Regulator | European Commission, national market authorities | UK Department for Business and Trade (DBT) |
|---|---|---|
| Geographic validity | All EU/EEA member states | Great Britain (England, Scotland, Wales) |
| Accepted after 2024 | Yes, indefinitely for most goods | Yes, UKCA available but CE still recognised indefinitely |
| Authorised representative | EU authorised representative required if manufacturer is outside the EEA | UK authorised representative (Responsible Person) required if manufacturer is outside the UK |
| Labelling | CE mark + EU authorised representative address | UKCA mark + UK authorised representative address |
EU Authorized Representative for Amazon Sellers
Understanding the differences between CE and UKCA marking is crucial for businesses selling in the EU and UK. Both systems require an authorised representative service if the manufacturer is based outside the region. The table below shows how the two conformity marks compare across key criteria.
Authorised Representative vs Responsible Person in the EU and UK
Many manufacturers are unsure whether they need an EU Authorised Representative or a UK Responsible Person. Both roles exist to support compliance, but their scope and responsibilities differ. Appointing the right partner through an authorised representative service is essential for safe and legal product sales in both regions
| Scope | Represents manufacturers outside the EU/EEA for CE-marked products | Represents manufacturers outside the UK for UKCA products |
|---|---|---|
| Legal basis | EU Regulations (MDR, RED, EMC, etc.) | UK product safety and conformity laws post-Brexit |
| Address required | Physical EU address on packaging, DoC, and technical files | Physical UK address on packaging, DoC, and technical files |
| Responsibilities | Document retention, regulatory communication, product registration | Same as EU AR, plus direct liaison with UK authorities |
| Market coverage | All EU/EEA member states | Great Britain (Northern Ireland continues CE rules) |
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