![]() While self-certification can be an option, products in other risk categories require the involvement of an authorised third party: a Notified Body. This means self-certification is only possible for Category I products. Ø Category III – Serious risk (of leading to irreversible harm to health and/or death). Ø Category II – Other risk (of leading to more serious injuries). Minimal risk products belong to Category I. Specifically, products involving minimal risk can be self-certified Identify whether a Conformity Assessment by a notified body is required or if you can self-certify the productĭepending on the risk category of your product, you may be able to carry out your self-certification. Ø Determine the standards you will adopt to satisfy these Directives.ī. Ø Identify the Directives that apply to your product. For example, an electrical meat grinder is covered by the Machinery Directive as well as the Low-voltage Directive. Lastly, it should be noted that a product can be covered by more than one Directive. These standards may not fit all of the requirements that concern a given Directive or regulation but still serve as a good starting point to achieve compliance. In addition, you can adopt other standards in the case where no harmonised standards exist. In other words, non-harmonised standards are only adopted within individual countries. Non-harmonised standards may differ from one country to another if there are no harmonised standards for the product concerned, or they only apply to certain aspects of the product. Nevertheless, using harmonised standards is the most straightforward way to compliance. Manufacturers can adopt their own standards to satisfy the Directives set out for them. This is because whether a manufacturer conforms to such harmonised standards is in fact voluntary. Harmonised standards can be used by manufacturers and importers as a guide to use for product compliance. These harminised standards are developed by a recongised European Standard Organisation: CEN, CENELEC, or ETSI. The European Commission states that a harmonised standard is one that has been published in the Official Journal of the European Union (OJEU) and applies to all countries in the EU. Such standards are implemented by individual EU countries and some are ultimately adopted by the European Commission and listed under the above-mentioned Directives. Under each Directive is listed a set of standards, which have been produced and updated by multinational committees and specify in detailed technical terms how these requirements are to be achieved. These lay out, in general terms, the requirements for products intended to be manufactured or imported into the EU. Identify the applicable Directive(s) and the harmonised standards you must satisfy.Īccording to the EU’s Blue Guide, the European Commission has published over 20 Directives. Self-certification, Modules, Directives and the Conformity Assessment Procedures are explained in the below section “The CE marking process”.Īs a manufacturer, you should follow these six steps in order to affix CE marking to your products:Ī. The proportions of the mark must also be correct. There is a mandatory requirement regarding the size of the CE marking displayed, namely a minimum height of 5 mm. Note that not all products require CE marking, such as cosmetics or foodstuffs. The choice for which product groups the CE marking is mandatory lies with the European Union. However, the CE mark is not an indicator of quality nor a certification mark. To protect consumers, CE marking is mandatory for some product types. They carry out the Procedures as listed in the relevant Modules according to the relevant Directives.Ī manufacturer can choose any Notified Body - for the relevant Directives and Modules - in any Member State of the EU. These Notified Bodies act as Independent Inspection organizations. Notified Bodies are organizations that have been nominated by a member state - and accredited - to carry out Conformity Assessment Procedures. self-certification is carried out, there is usually no need for an identification number. The CE mark consists of the CE logo itself, as well as the four-digit Notified Body identification number, usually found to the right of or below the CE logo. It may also be found on products sold elsewhere if they meet EU standards. ![]() The CE mark indicates that the product concerned meets specified standards that allow it to be sold freely anywhere in the EU, regardless of country of origin. “CE” is the abbreviation of “conformité européenne” (French for “European conformity”).
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