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Manufacturer

As the manufacturer, you must ensure that the product is designed in accordance with all relevant requirements for the markets on which it will be placed. You decide the circumstances under which the product can be made available. It does not matter if it is you or someone else who actually designs, manufactures, labels or packages the product.

You are a manufacturer if you or your company designs or manufactures a product and makes it available on the market. Also if you arrange for a product to be designed or manufactured and then place it on the market in your own name or under your own brand. You are considered to be the manufacturer if you assemble, package, process or label finished products and place them on the market in your own name or under your own brand.

You are also considered to be the manufacturer if you alter the intended use of a product in such a way that material requirements or other legal requirements become applicable. If you substantially modify or reconfigure a product, thereby creating a new product to place on the market, you are considered to be the manufacturer.

Requirements you must meet before making products available

As the manufacturer you must ensure that the electrical product is manufactured in accordance with the requirements, and you must ensure that a conformity assessment has been carried out in accordance with the procedures applicable to the product. You therefore need to know what rules and requirements are applicable to your product. As the manufacturer, you are responsible for drawing up the technical documentation and ensuring that the product is tested to verify that it complies with the requirements.

You must ensure that the product is correctly labelled according to the requirements applicable to the product. According to current requirements, you, the manufacturer, must make sure the product is labelled with the CE mark and with identification marking. The product must also bear the name and address of the manufacturer. If you, the manufacturer, are not located in the EU/EEA, the product must also be labelled with the importer's name and address. You are also responsible for drawing up the user manual and the safety information which is required in Swedish.

EU declaration

Before placing a product on the market, you must draw up an EU declaration of conformity certifying that the product meets all applicable requirements. This EU declaration must be signed by you, the manufacturer, to demonstrate that you accept responsibility for the product and thereby affirm that the product complies with the requirements set out in the declaration. The EU declaration must be kept for 10 years from the date the product is placed on the market.

You must take a preventive and collaborative approach

As the manufacturer, you play a crucial role in preventing injury, loss or damage. It is up to you to ensure that the products continue to meet the requirements as they are manufactured. If you find deficiencies or potential deficiencies when you inspect the products, you must take action. You may also be required to perform random testing of products that have already been placed on the market.

Requirements you must meet in injury, loss and damage prevention

You must ensure that all the products you have bought and sold to other economic operators can be traced, and you must have procedures in place to investigate potential deficiencies uncovered for example by complaints and claims. You must organise recalls and take other action as necessary. You must cooperate with others and notify the market surveillance authorities of deficiencies you identify.

Because you are the manufacturer, you must also carry out random testing as part of your activities specifically to prevent injury, loss or damage where necessary. You must investigate and if necessary keep a record of all complaints received about, products which do not meet the requirements, and product recalls. In these circumstances, you must inform the distributors of any such monitoring.

Last reviewed: 2020-12-12