CRA FAQ

1. Notwithstanding any obligations set out in applicable Union harmonisation legislation, a product subject to legislation referred to in paragraph 5 may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3 in respect of that product.

2. For the purposes of this Article, the economic operator referred to in paragraph 1 means any of the following:

(a) a manufacturer established in the Union;

(b) an importer, where the manufacturer is not established in the Union;

(c) an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer's behalf;

(d) a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union ( Article 4(1) and (2) of Regulation (EU) 2019/1020)

A product with digital elements can be placed on the Union market if there is an economic operator established in the Union that is responsible inter alia to verify that the EU declaration of conformity and the technical documentation have been drawn up and to cooperate with market surveillance authorities.

A manufacturer who is not established in the Union, therefore, is required to have an importer, an authorised representative or a fulfilment service provider to perform those tasks.