Authorised Representative

The role of an Authorised Representative is only applicable if you are a manufacturer outside a specific market (e.g. EU, UK) and want to sell your products onto said market. A manufacturer may appoint an Authorised Representative to act on his behalf in carrying out certain tasks and is not obligatory. As an exception, according to the legislation on Marine Equipment, medical devices and in vitro diagnostic medical devices the manufacturer outside said market must designate an Authorised Representative.
It is important to note there is no requirement to appoint a European Representative if the manufacturer is in the European Economic Area (Norway, Liechtenstein, and Iceland).

According to the definition, an Authorised Person must be a “natural or legal person” established in the appropriate market. The main role of an Authorised Representative is to represent the manufacturer in dealings with specific regulators, acting as a liaison.

Authorised Representatives have a number of responsibilities under the applicable regulations. These roles and responsibilities include:

• Keep the declaration of conformity and the technical documentation at the disposal of national surveillance authorities and cooperate with them at their request.
• Upon a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product.
• Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.

In addition to the above, the name and contact details of the European Authorised Representative must be included on the labels of products sold in Europe. This includes the outer packaging, product labels, and instructions for use.

There is no Authorised Representative list; a manufacturer is free to assign any Authorised Representative of choice. If there is no Authorised Representative, the main obligations with regard to the product fall onto the importer or the Fulfilment Service Provider. This is because they are recognised as a European Economic Operator by the EU Market Surveillance Regulation (MSR). However, this is not something that is recommended as most Fulfillment Service Providers do not want to take on any obligations with regard to the products on their website. If the importer will be seen as the main economic operator, a complete technical file must be provided and every importer must affix their details onto the label. If you are looking for a suitable AR that will help you gain access to the EU/UK market fast and efficiently, our experts with 25+ years of experience are happy to help.