Topic outline

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    Identify your role


    In addition to product requirements, there are statutory obligations for economic operators, i.e. the manufacturer, authorised representative, importer, distribution service provider and distributor of the product. It is important that you recognise your role and understand your responsibilities as an economic operator. The Role identification section of the learning environment describes business’s responsibilities in different roles.

    Manufacturer refers to a business that manufactures a product or has it manufactured and markets it under its name or trademark. The product manufacturer is responsible for ensuring that the product is safe and compliant. The manufacturer must carry out all the conformity assessment procedures relating to the product, draw up the required documents and affix the necessary markings to the product.

    Authorised representative refers to a business established within the EU that has received a written mandate from the manufacturer to act on their behalf in relation to specified tasks.

    Importer refers to a business established within the EU that places products imported from a third country on the EU market. The importer must ensure that the manufacturer has fulfilled their obligations regarding the assessment of the product’s conformity, drawn up the required documentation, and affixed the necessary markings. The importer is responsible for ensuring that the products comply with the European requirements and any specific national requirements.

    Distribution service provider refers to a business that  provides at least two of the following services during its operation: storage, packaging, addressing and dispatch. The distribution service provider is therefore the business responsible for the product unless there is a manufacturer, authorised representative or importer in Europe.

    Distributor refers to a business in the supply chain other than the manufacturer or the importer who makes a product available on the EU market. In other words, distributor refers to a business that sells a product manufactured in the EU, or that has previously been placed on the EU market. Distributors include retailers and wholesalers, along with commercial sellers of used goods, such as recycling centres and flea markets. The distributor must check that the product bears the required markings, and that the required documents, instructions and safety information in Finnish and Swedish have been included with the device.

    According to EU legislation, an economic operator importing products to Finland can be either an importer (importing a device from a third country) or a distributor (importing a device from the EU market). You can find more information on the obligations of economic operators on the Tukes website.

     

    The obligations of economic operators as a table

     

    Obligations of economic operators 

    Manufacturer 

    Authorised representative 

    Importer 

    Distribution service provider

    Distributor 

    Makes only compliant products available on the market 

    X

    X

    X

     

    X

    CE marking, affixes

    X

    (X)

     

     

     

    CE marking, checks

     

    X

    X

    X

    X

    EU declaration of conformity or declaration of performance, draws up and stores for 10 years: 

    X

    (X)

     

     

     

     

    EU declaration of conformity or declaration of performance, keeps available for 10 years

     

    X

     

     

     

    EU declaration of conformity or declaration of performance, stores a copy for 10 years

     

     

    X

    X

     

    EU declaration of conformity or declaration of performance, provides to the authorities on request 

    X

    X

    X

    X

    X

    Technical documents, draws up and stores for 10 years 

    X

     

     

     

     

    Technical documents, ensures availability for 10 years

     

    X

    X

    X

     

    Technical documents, provides to the authorities on request

    X

    X

    X

    X

    X

    Carries out the conformity assessment procedure 

    X

     

     

     

     

    Ensures that the conformity assessment procedures have been carried out

     

     

    X

     

     

    Ensures that the storage or transport conditions do not jeopardise the product's compliance with the requirements 

    X

    (X)

    X

     

    X

    Keeps a record of non-compliant equipment and, if necessary, notifies the distributors of such equipment 

    X

    (X)

    X

     

     

    Ensures that the product bears a type, batch, serial number, or another marking that allows it to be identified 

    X

    (X)

    X

     

    X

    States their name, the registered trade name or registered trademark, and the address at which they can be contacted

    X

     

    X

    X

     

    Ensures that the product bears the manufacturer’s and/or importer’s name, the registered trade name or registered trademark, along with the address at which the manufacturer and/or importer can be contacted

     

    (X)

    X

     

    X

    Takes the necessary measures in case of any suspicion of non-compliance of the product 

    X

    (X)

    X

    X

    X

    Cooperates with the authorities 

    X

    X

    X

    X

    X

    Keeps identifying information on the economic operators to whom it has delivered products for 10 years from bringing the last product to the market.

    X

    X

    X

     

    X

    Keeps identifying information on the companies that have supplied it with products for 10 years from bringing the last product to the market. 

     

     

    X

     

    X



    X: Obligated to take care of the matter
    (X): The manufacturer and the authorised representative can agree in writing on the authorised representative taking care of these duties/obligations on behalf of the manufacturer

    This table applies to products included in the scope of application of NLF-adapted regulations and those listed in article 4 of the Market Surveillance Regulation. In addition to the obligations listed in the table, special legislation may contain additional requirements concerning the manufacturer, importer and distributor.

    The requirements concern the fulfilment service provider in connection with the products it handles when the manufacturer, importer or authorised representative is not located in the EU. The requirements concerning fulfilment service provider only apply to products included in the scope of application of the regulations listed in Article 4(5) of the Market Surveillance Regulation:
    Construction Products Regulation (EU) No 305/2011
    PPE Regulation (EU) 2016/425
    Gas Appliances Regulation (EU) 2016/426
    Outdoor Noise Directive 2000/14/EC
    Machinery Directive 2006/42/EC
    Toy Directive 2009/48/EC
    Ecodesign Directive 2009/125/EC
    RoHS Directive 2011/65/EU
    Pyrotechnic Articles Directive 2013/29/EU
    Recreational Craft Directive 2013/53/EU
    Simple Pressure Vessels Directive 2014/29/EU
    EMC Directive 2014/30/EU
    Non-Automatic Weighing Instruments Directive 2014/31/EU
    Measuring Instruments Directive 2014/32/EU
    ATEX Directive 2014/34/EU
    Low Voltage Directive 2014/35/EU
    Radio Equipment Directive 2014/53/EU
    Pressure Equipment Directive 2014/68/EU



    Learn more about corporate responsibilities

    I Know My Product webinar: Roles and responsibilities

    The obligations of economic operators as a table on the Tukes website

    Manufacturer’s obligations on the Tukes website

    Importer’s obligations on the Tukes website

    Distributor’s obligations on the Tukes website

    I Know My Product webinar: Private label

     

      

►Manufacturer