Tasks of economic operators regarding products subject to certain Union harmonisation legislation
Article 4
Open ↗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. 3. Without prejudice to any obligations of economic operators under the applicable Union harmonisation legislation, the economic operator referred to in paragraph 1 shall perform the following tasks: (a) if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity or declaration of performance and technical documentation, verifying that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keeping the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensuring that the technical documentation can be made available to those authorities upon request; (b) further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority; (c) when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof; (d) cooperating with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance with the requirements set out in Union harmonisation legislation applicable to the product in question, or, if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on its own initiative, where the economic operator referred to in paragraph 1 considers or has reason to believe that the product in question presents a risk. 4. Without prejudice to the respective obligations of economic operators under the applicable Union harmonisation legislation, the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document. 5. This Article only applies in relation to products that are subject to Regulations (EU) No 305/2011 ( 34 ) , (EU) 2016/425 ( 35 ) and (EU) 2016/426 ( 36 ) of the European Parliament and of the Council, and Directives 2000/14/EC ( 37 ) , 2006/42/EC ( 38 ) , 2009/48/EC ( 39 ) , 2009/125/EC ( 40 ) , 2011/65/EU ( 41 ) , 2013/29/EU ( 42 ) , 2013/53/EU ( 43 ) , 2014/29/EU ( 44 ) , 2014/30/EU ( 45 ) , 2014/31/EU ( 46 ) , 2014/32/EU ( 47 ) , 2014/34/EU ( 48 ) , 2014/35/EU ( 49 ) , 2014/53/EU ( 50 ) and 2014/68/EU ( 51 ) of the European Parliament and of the Council.