![]() ![]() The manual provides users with instructions on the usage of the product, particularly in potentially dangerous situations. Manuals must be written in the language(s) of the country in which the product is sold or consumed. You have to store all documentation for a minimum of 10 years after the manufacturing date. If you import goods from outside the European Economic Area, make sure that the foreign manufacturer confirms in writing that he will provide you with the technical documentation when this is requested by a market authority. Keep in mind that the requirements may differ per directive. In the technical documentation you include drawings, specifications, test reports, inspection certificates, manuals and a Declaration of Conformity. Make the documentation available to market surveillance authorities in case of a request. You have to draw up technical documentation in which the conformity of your products is stated. Step 5: Draw up the required technical documentation and make it available ![]() You can conform with the necessary essential requirements of the directives by applying harmonised standards. An important part of this procedure is the risk assessment. Step 4: Test the product and check its conformityĪs manufacturer, you are responsible for testing your products and checking that they meet the essential requirements and applicable directives. You can search the NANDO Information System for the notified bodies per country and directive. In most cases this only applies to products with high safety risks. You don’t have to make use of a conformity assessment body in every case. If you are not certain of this, you can have an assessment made by an independent conformity assessment body. When you apply a directive, you have to get it right. Decide if you need to have an independent conformity assessment For instance, product warnings and contact details of the producer or importer. Make sure also to pay attention to the directives’ regulations on product descriptions and manuals. You are allowed to use these standards, or to use another option to show you meet the requirements. Products that are produced using the harmonized standards imply a “presumption of conformity”. Step 2: Check product specific requirementsĬheck which EU directives apply to your products and if these standards are met. To receive the standards on paper or digitally, you can request them on the website of the NEN. ![]() The Netherlands Standardisation Institute ( Nederlands Normalisatie-instituut, NEN) manages and develops these standards. The European harmonised standards state the essential requirements per directive in detailed and technical terms. For example, electrical and electronic products fall under the low voltage, EMC and RoHS Directive. In some cases, more than one directive applies to the same product group. In the directives, you will find the EU legislation that applies to each product group. The European Commission has made directives for product groups that require a CE marking. Step 1: Find the EU-directive(s) and harmonised standards that apply ![]()
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