Authorized representative services in EU and UK

The Lovat company provides an authorized representative service for companies in the EU and the UK. We offer favorable and transparent terms of cooperation for all our clients. With vast practical experience and a team of skilled experts, our company will help you quickly and easily access the European Union and the UK market. Read below about the features of the service, as well as who and when it may be needed.

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Authorized representative

When and who requires an EU/UK Responsible Person?

In mid-2021, a new EU regulation on the safety of goods came into force. If you have a CE-marked product in your range, but the product itself is manufactured outside the European Economic Area, the manufacturer must have an authorized representative. He will act as an intermediary responsible for the compliance of the goods with the Regulation.

Some goods such as toys, measuring instruments, and mobile phones require a Domestic representative to get CA marks and permission to be placed on the market. In some cases, Marketplaces (eBay, Amazon, Etsy, or other) can ask you to provide a local address even if you sell goods from other categories.

This marking and the authorized manufacturer must be assured by 16 July 2021. The CE marking must be affixed to the accompanying document, parcel, product packaging, or surface.

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.

Uk authorized representative

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:

Use of our legal address within the EU on all product-related labeling. This ensures you comply with EU and UK regulations.
Thorough review of your EU declaration of conformity and technical documentation. We’ll ensure your documents meet all the requirements.
Review of your Quality Management System documentation. We’ll verify your system aligns with regulatory expectations.
Preparation and registration of the initial product in the electronic system. We’ll handle the electronic registration process for you.
Update the listing of product registration in the electronic system. Keep your product registration current with our assistance.
Assistance in communication between you and the competent authority. We’ll bridge the gap and facilitate smooth communication.
Assistance and coordination of complaint handling and incident reporting. We’ll guide you through the complaint and incident reporting process to the authorities.
Updates regarding regulatory changes that might impact your devices and registrations. Stay informed with our regulatory change notifications.
Technical file.
Documents storage for 10 years.
Response to market surveillance authorities’ requests for information.

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Representative

EU and UK-authorized representative services

The product label, packaging, as well as conformity declarations, must contain the address of the entity established in the EU/UK that is responsible. This is essential to have access to the market. Representatives established inside the EU or the UK take care of the communication with the authorities.

The price depends on the number of products you are going to place on the market. Current Lovat users can get a 40% discount.

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.