Apr 03, 2017 9 answers to ce marking questions and translation requirements this year croatia becomes the 28th eu member state to require ce marking. Products may not qualify for ce marking under all applicable directives at all times. All machinery must be accompanied by instructions in the official community language or languages of. Note there are very specific requirements regarding how the ce mark should appear on your product. The requirements mentioned above apply to a variety of different products, from medical devices. Directive 201435eu on low voltage devices specifies in detail the essential requirements the product must meet in order for the manufacturer to affix the ce marking. User manuals, product documentation and ce marking. Cemarkings impact upon user manuals the european new approach directives are the basis for ce conformite europeenne marking. However, the other general parts of the user instructions must be supplied in the language of the end user.
Eu machinery directive 200642ec translation requirements. According to these directives, products must meet certain requirements before being sold in the eu, with manuals playing a vital role in the regulatory process. Depending upon the applicable ce marking directives that are relevant to your. How to write a user manual when importing products to the eu. In this article, i will show you how to find the eu requirements for user manuals for your specific product group and how to create compliant user manuals for ce marking. Since 1985, any product sold in the european union must bear the ce mark certification. Many companies further opt to translate additional supporting materials including marketing materials and information sheets to accompany their products, devices and machines. One of the requirements in any eu directive is that a user should. Other member states with two official languages cyprus, malta and ireland accept the sole use of english. Exemption from the language requirement in specific cases. Determine the eu requirements for user manuals as specified in the applicable, relevant ce marking product legislation. Ce mark guide for electronic hardware products emc fastpass. Information on ce marking in eu countries, how to reproduce the ce mark. Ce marking translation services language scientific.
One of these is to develop a user manual and translate it to the. Current eu law requires albeit based on different legal regulations both the community institutions and the machine manufacturers to produce translations in the languages. We conduct audits under the scope of the applicable directives and compile the technical file for your product or machinery. Ce marking is not required when selling into the united states, australia or any other market. The ce marking is also found on products sold outside the eea that have been manufactured to eea standards. A copy of the original instruction manual should be included as part of the technical file for a product, along with any translations made into other community languages.
Normally a technical file includes information about design, manufacture, and use of a product. Informational guide to ce marking requirements nts. The machinery directive ranslation requirements t are stated in annex i, section 1. The ce marking association assists manufacturers, importers and distributors on a regular basis with the technical documentation requirements and we have a range of services to meet your needs. Manufacturers are advised to check this with the national. One is that everyone talks about ce marking translation requirements without actually reading the specific directives that apply to their products. You must make sure that your product complies with all the relevant requirements before affixing the ce marking to it. The general principles of the ce marking are contained within regulation ec no 7652008 which sets the requirements for accreditation and market surveillance relating to the marketing of products. The instructions accompanying the machinery must be either original. Ce marking is the manufacturers declaration that the product meets the requirements of relevant directives.
Depending on product, there are also special ce requirements for the user manual. European market access with a trusted notified body. Generally, the manufacturer is responsible for ce marking. Badly written these can detract from the quality of your product, and even cause. Previously, enforcement only targeted eubased importers. A copy of the original instruction manual should be included as part of the technical file for a. First, it gives any importer an overview of all necessary steps to get an official ce marking on its product. That said, things are changing as the eu is flooded by noncompliant and unsafe products originating from cross border ecommerce companies. How do you determine whether your product requires ce marking. Since you can selfcertify your products for a ce mark, if you are sure your product is compliant, then you can apply the ce mark to your pcb without testing. Ce marking and the requirement for translations f2 tech notes.
In this article, ferry vermeulen what is required regarding the user manual, as well as other ce requirements. The technical documentation for a product plays a vital role in the ce marking process. Many of these ce marking directives also set requirements for instructions for use. Any medical device should include a user manual, unless the product could be considered as belonging to risk class i or iia and could be used safely without such manual. Ce marking obtaining the certificate, eu requirements your europe. Learn the basics on technical files with our helpful guidance we use cookies to help us to improve your online experience. The marking is obligatory, and it shall be affixed to products if this. Verify requirements directive 201435eu on low voltage devices specifies in detail the essential requirements the product must meet in order for the manufacturer to affix the ce marking.
Ce marking is a complex procedure with lots of requirements. In other words, it contains everything needed to show that the essential requirements of products bearing the ce marking have. Product documentation and user manuals can be difficult to use if not written precisely, concisely, and with consistent terminology in appropriate. X x x electrical safety test report test report showing compliance with electrical safety essential requirement art. Ce marking and labelling finnish standards association sfs. Eu foreign language labeling requirements ce mark, ce. Language requirement for information about medical devices. Eu translation requirements multi language management.
Ce marking indicates that your medical device complies with the applicable eu regulations and enables the commercialization of your products in 32 european countries. Eu country specific medical device registration requirements. Ce marking translation requirements, polilingua ce marking. Low voltage directive 201435eu see 201435eu, article 6 9. The yamaha robot robot and controller is one component that is incorporated into the customers system builtin equipment, and we declare that the yamaha robots conform to the ec. At ce check we will store this in our cloud service for you. The ce marking is placed onto the product or to its data plate. Ce marking is a visible sign that the product complies with all relevant product supply law, and its presence together with the declaration of conformity gives the product to which it is affixed. In the other countries where the machinery directive applies. The manual provides users with instructions on the usage of the product, particularly in.
Manufacturers are advised to check this with the national authorities concerned. The ce mark above is a symbol that a manufacturer see definition below affixes to a product so that it can be sold in europe. Ce marking is only obligatory for products for which eu specifications exist and require the affixing of ce marking. The language of the user manual must be in the language of the country where you plan to sell the product. Eu machinery directive 200642ec translation requirements and. Ce mark in europe rules on standards for products that are not subject to eu harmonisation, product groups covered by the mutual recognition principle, national contact points.
Ce marking, or ce mark, is a symbol placed on a product indicating that it has been certified to be sold in europe freely. As a mandatory process for all products that will be available in any eu nation, the mark. Determine the appropriate harmonised standard to instruct users. The user manual is an important part of the ce marking requirements.
Ce marking also supports fair competition by holding all companies accountable to the same rules. When the size of the product does not allow this, the marking can be placed onto the. Product manuals, or user guides, are not just nice to have. Cemarkering certificering, euvoorschriften uw europa. Importing countries under ce marking require translation of labeling, instructions for use, packaging, and user manuals into their designated language s. Oct 08, 2012 by placing the ce marking on a product a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve ce marking. As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing ce marking for your product, regardless of whether you outsource any. Ce marking for european directives european regulatory language requirements ce marking on a product is a manufacturers declaration that the product complies with the essential requirements of the relevant european health, safety and environmental protection legislations, in practice by many of the socalled product directives which. Ce marking obtaining the certificate, eu requirements. Ce is an acronym for conformite europeenne, which means, conforms to european legislation. Create a user manual for the product and translate it to the appropriate language.
The ce logo is affixed to the product at the end of the ce marking process and is a declaration by the manufacturerimporter that the product meets the essential requirements of any applicable ce. Ce marked products are entitled to free movement throughout the european market eu. Broadly, sections of documentation and materials related to safety must be translated. The marking is obligatory, and it shall be affixed to products if this is required by the relevant directive. This makes the ce marking recognizable worldwide even to. Directive 9342eec clearly states which items should be in the user manual, for example safety instructions.
Ce marking for european directives the language center. The manuals language and content demands may differ per directive. These rules address the size and location of the marking. Ce dedicated fasttrack and ce onsite fasttrack are not available for devices. If an eu user imports a machine and instructions have not been translated into the language of their. Importing countries under ce marking require translation of labeling, instructions for use, packaging and user manuals into their designated language s. The words original instructions must appear on the language. Some products are subject to several eu requirements at the same time. Mar 19, 2009 eu foreign language labeling requirements there are two major areas of confusion about the translation requirements when ce marking a product for export to the eu states. Ce marking is most probably required if you export to the 27 european union eu and 3 european free trade association efta member states the following 20. For ce marking, importing countries require translation of labeling, instructions for use, packaging and user manuals into their designated language s. The ce marking and assorted documents like the declaration of performance dop show that the manufacturer has researched the attributes of a product according to the relevant standard or standards and maintains them there. Ce marking and the requirement for translations f2 tech. European union ce marking ce marking is not permitted for investigational devices but may be required by other directives.
There are specific rules to adhere to for the ce marking. In order to ensure that your product is able to be widely continue reading ce marking. Ce marking for european directives european regulatory language requirements ce marking on a product is a manufacturers declaration that the product complies with the essential requirements of. Eu state they may agree to translate instructions on behalf of. This means that manufacturers will be able to place products, devices and machines on the croatian market, but those items must have documentation in the croatian language. Typically, portions of documentation and materials related to safety must be translated. Ce marking s impact upon user manuals the european new approach directives are the basis for ce conformite europeenne marking. Create a user manual for the product and translate it to the appropriate language depending upon. The language requirement applies to all medical devices comprised by the executive orders regardless of the users qualifications or profession. The european new approach directives are the basis for ce conformite europeenne marking. By affixing the ce marking to a product, a manufacturer declares that the product meets all the legal.
As a mandatory process for all products that will be available in any eu nation, the mark legally denotes that the manufacturer takes full responsibility for the product compliance i. With a properly drawn up declaration and an affixed ce marking on the product, buyers, endusers and market surveillance authorities will assume that the product is compliant with the eu directives and harmonised standards mentioned in the declaration of conformity. The ce marking has a height of at least 5 millimetres. European rules for obtaining ce marking on products sold to eu member states or in the eea conditions and product requirements for the. If a directive does not contain any requirements for a user manual, the economic operator can look into the relevant harmonised product standards. Checklist for ce marking in the netherlands business. A list of all the standards youve used for the ce marking process either fully or partially, or your own standardsmethods for verifying compliance with the respective ce directive. What are the official languages of the european countries. Directive 201435eu is intended to remove all obstacles to the sale of low voltage electrical equipment within the eu, while, at the same time, ensuring that they offer the. Is english language user guides accepted all over the eu, or do i. Other products shall not be labelled with a ce marking.
Ce marking is a visible sign that the product complies with all relevant product supply law, and its presence together with the declaration of conformity gives the product to which it is affixed presumption of conformity with relevant product safety directives. Current eu law requires albeit based on different legal regulations both the community institutions and the machine manufacturers to produce translations in the languages of the member states. European ce marking and translation requirements language. There are over 20 different directives that define ce marking requirements for different product classes. All machinery must be accompanied by instructions in the official community language or languages of the member state in which it is placed on the market andor put into service. The mark is mandatory for products which fall under one of 24 european. In the eu, a manufacturer can use european harmonized standards to comply with the relevant essential health and safety requirements of the ce marking directives and accordingly affix ce marking. Ce marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the european economic area eea. Manufacturers must clearly identify in the labeling, the directives with which the product complies. Where to find the ce requirements for an user manual.
If europe is the target market, the manufacturer needs to perform several actions in order to meet the requirements to obtain the ce marking. Product documentation and user manuals can be difficult to use if not written precisely, concisely, and with consistent terminology in appropriate language. This usually involves testing and certification by a thirdparty certification body known as a notified body e. The ce marking is a european proof of conformity and is also known as trade passport to europe that allows manufacturers and exporters to circulate products freely within the eu. In other words, it contains everything needed to show that the essential requirements of products bearing the ce marking have been met. Other documents, such as calculations, simulations, etc. It is the responsibility of an economic operator usually the manufacturer to verify if ce marking directives relevant to its product contain mandatory requirements for a user manual. Ce marking internal market, industry, entrepreneurship.
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