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.


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 Responsible Person for imports to the EU and the UK. Our fee is 80 euros per month. If you are a Lovat user you can ask your account manager for a Special offer for Lovat users.

This subscription includes:

  • Use of Legal address;
  • The Declaration of Conformity verification;
  • Technical file;
  • Documents storage for 10 years;
  • Response to market surveillance authorities’ requests for information.

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.