Authorized representative
services in EU and UK
Lovat offers authorized representative services in the EU and UK with transparent terms and expert support. We ensure quick and seamless access to these markets. Learn more about the service and its benefits below
When and who requires an EU/UK Responsible Person?
EU regulations since July 16, 2021, mandate that manufacturers of CE-marked products made outside the EEA appoint an authorized representative to ensure compliance.
- Required for Specific Products: Toys, measuring instruments, mobile phones, and more need a Domestic Representative for CA marking and market access.
- Marketplace Requirements: Platforms like Amazon, eBay, and Etsy may also demand a local address for other product categories.
- Mandatory Marking: The CE marking must be on the packaging, accompanying documents, or product itself.
You can get free advice on whether you require an AR in the EU or UK, just fill out this form. You can also get a consultation on any question that has arisen.
Why should you use an authorized representative?
The presence of a European-authorized representative 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.
What do we do as authorized representatives?
Lovat can be your one-stop shop for import compliance in the EU and UK. Our monthly subscription of €80 provides you with all the essentials for placing your products on the market. Lovat users can also inquire about special offers with their account manager.
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.
Transferring an Authorized Representative (AR)
Transferring an Authorized 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:
- Manufacturers must revise their product labeling to include the information of the new AR.
- It’s essential to clearly define and document the end date of the agreement with the previous AR and the start date with the new AR. All relevant documentation should be updated accordingly to reflect this change.
- Manufacturers must arrange for the outgoing AR to forward any complaints from healthcare professionals, users, or patients concerning devices released to the market before the AR transfer date to either the manufacturer or the new AR.
- Ideally, the details of this transfer, including responsibilities and timelines, should be outlined in a formal Agreement signed by the manufacturer, the outgoing AR, and the incoming AR.
CE Label 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). 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. Manufacturers, importers, and distributors are responsible for ensuring product compliance.
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.
- The transition period for using CE marking in the UK has been extended until December 31, 2024 for certain product categories.
- Beyond this date, UKCA marking will become mandatory, although CE marking will still be recognized for specific products.
For assistance in ensuring CE or UKCA compliance for your products, contact us to streamline the process and meet regulatory requirements.
EU Responsible Person for Amazon Sellers
If you’re selling on Amazon in the EU, compliance with EU regulations is crucial. Amazon requires sellers to designate an EU Responsible Person for CE-marked products manufactured outside the EEA. This ensures your products meet the necessary safety, health, and environmental standards.
Key Benefits of Our Service:
- Compliance Assurance: We act as your official EU Responsible Person, ensuring your products meet all EU regulatory requirements.
- Seamless Market Access: Fulfill Amazon’s requirements to maintain uninterrupted listings.
- Support for CE Marking: Assistance with documentation, declarations of conformity, and product labeling.
- Regulatory Updates: Stay informed about changes that could impact your products.
Ensure your Amazon business stays compliant and competitive in the EU market. Contact us today to get started!
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