The CE mark is a required mark that 70 per cent of products considered for European import must have. This mark is the symbol of a standard that the European Union (EU) set that guarantees the safety of all products that contain this label. The mark is commonly referred to as the "Trade Passport To Europe," and if your product(s) has this mark, it can be traded to the 28 countries that make up the EU and the European Free Trade Association (EFTA).
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Things you need
- European authorised representative
Hire a European Authorized Representative. Every person who is wishing to obtain a CE marking for a product must get a European Authorized Representative. This person must be authorised by the European Union and can't be a manufacturer of medical devices, according to the certification guidelines that were established by the EU. This representative's duties must be clearly outlined in a contract that is established between the manufacturer and the representative before any action is taken. The manufacturer is solely responsible for the actions of the representative who is hired so limitations and task outlines should be established early on.
Run tests on the product and evaluate the products make-up. The authorised representative will have to run a series of tests on the product that vary depending on the product that is under evaluation. The tests that are run will help ensure multiple sectors of safety. For example, if the product is a toy, it will be tested for toxic chemicals or easily ingested pieces. The authorised representative is not allowed to make any alterations to the product.
Product testing guidelines and expectations may be obtained from the state department in the EU state that you wish to receive certification from.
Apply for certification from your EU state of choice. After you receive certification from one EU state, you can distribute your product to any country that is in the EU or the EFTA.
Even if you have a variety of distributors or a variety of products, you only need one authorised representative. This representative can approve multiple products.
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