Article 4 and 5 of the Market Surveillance Regulation (EU) 2019/1020 requires that companies established outside the EU, but selling certain products to consumers in the single market, must have an authorised representative – in particular products that require CE marking.
In practice, this means that non-EU companies pay EU entities to act as their authorised representative. Further, the packaging must also include the name and address of the authorised representative.
In this guide, we explain how this works in practice, and what the consequences can be if you don’t have an authorised representative.
1. This guide only covers EU AR requirements within the scope of the Market Surveillance Regulation (EU) 2019/1020. If you are looking for authorised representative requirements concerning medical devices, then you can find the relevant article here.
2. This guide covers authorised representative requirements in the UK.