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. It is a legal document that is mandatory for products that fall within the scope of ce marking. According to the conformance website, this mark indicates that the item has been checked and it meets the standards of the ce marking directives, set by the eu. The collaboration with certification experts runs smoothly and they are a valuable partner for us.
Ce marked products are entitled to free movement throughout the european market eu. Ce marking european commission choose your language. Ce mark guide for electronic hardware products emc fastpass. Product documentation and user manuals can be difficult to use if not written precisely, concisely, and with consistent terminology in appropriate language. The technical documentation can play a vital role in protecting a company, as it will retain information on how the product was developed and how it has evolved during the production. Ce marking obtaining the certificate, eu requirements. A declaration of conformity as well as a manual in danish or in the language of the country in which the craft was bought. For ce marking, importing countries require translation of labeling, instructions for use, packaging and user manuals into their designated language s. Informational guide to ce marking requirements nts. Create a user manual for the product and translate it to the appropriate language depending upon the countries in. General information regarding the ce margeneral information regarding the ce marking. It should also contain instructions for simple control and maintenance.
Products may not qualify for ce marking under all applicable directives at all times. Depending on the kind of product, the declaration can be stored electronically in the technical file, or must be provided with the product. If an eu user imports a machine and instructions have not been translated into the language of their eu state they may agree to translate instructions on behalf of the manufacturer, who must be satisfied that the translation is correct because they remain responsible for the validity of the. The ce marking is easily visible, readable and permanent. Importing countries under ce marking require translation of labeling, instructions for use, packaging, and user manuals into their designated language s. Ce marking home the ce marking an acronym for the french conformite europeenne certifies that a product has met eu health, safety, and environmental requirements, which ensure consumer safety. The instructions accompanying the machinery must be either original instructions or a translation of the original instructions, in which case the translation must be accompanied by the original instructions. Ce requirements for user manuals certification company. In order to ensure that your product is able to be widely continue reading ce marking. Eu translation requirements multi language management. This makes the ce marking recognizable worldwide even to people who are not familiar with. Badly written these can detract from the quality of your product, and even cause. Cemarkings impact upon user manuals the european new approach directives are the basis for ce conformite europeenne marking. Austria german belgium dutch, french and german bulgaria bulgarian cyprus english and greek.
If a directive does not contain any requirements for a user manual, the economic operator can look into the relevant harmonised product standards. By affixing the ce marking to a product, a manufacturer declares that the product meets all the legal requirements for ce marking and can be sold throughout the eea. A significant stage of the ce marking process is to produce technical documentation for the product to provide evidence of conformity for the relevant legislation. X and its accessories and is available in 10 languages. Most people usually refer to this document as the instruction booklet. Other member states with two official languages cyprus, malta and ireland accept. 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. Ce marking is a complex procedure with lots of requirements. Many companies further opt to translate additional supporting materials including marketing materials and information sheets to accompany their products, devices and machines. Depending on the product, importers are required to ensure full compliance with all relevant ce directives a process that is far more complex than requesting a test report from your supplier. Oct 08, 2012 the ce marking is at least 5 millimetres unless a larger minimum dimension is specified in the relevant directive. Importing products from china to the european union.
Eu machinery directive 200642ec translation requirements. Typically, portions of documentation and materials related to safety must be translated. This year croatia becomes the 28th eu member state to require ce marking. European union ce marking ce marking is not permitted for investigational devices but may be required by other directives. Ce requirements for user manual certification company. Is english language user guides accepted all over the eu, or do i need to.
X user manual is a complete guide to the moleculight i. When the size of the product does not allow this, the marking can be placed onto the packaging or in accompanying documents, such as the user manual. No particular languages are specified by the eu directives although it is. These 28 countries have adopted into national law the machinery directive 200642ec. The commission guide to the machinery directive gives the following information. 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. As a notified body for nearly all eu product safety directives, our cemarking conformity assessment services provide you with the expertise you need to achieve compliance. Manufacturers in the european union eu and abroad must meet ce marking requirements where applicable in order to market their products in europe. Ce marking indicates that your products comply with stringent eu product safety directives. What are the official languages of the european countries.
Cemarking indicates that your products comply with stringent eu product safety directives. The role of customs in maintaining safety, health and environmental requirements of products entering. Ce marking is only obligatory for products for which eu specifications exist and require the affixing of ce marking. Depending on the product, certain directives should be considered. Our services do not guarantee a ce marking certificate will be issued within a certain amount of. Ce marking also supports fair competition by holding all companies accountable to the same rules. 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. However, achieving compliance can be a complex process. Provide an instruction manual in the language of the user. Ce marking for european directives the language center.
Importing countries under ce marking require translation of labeling, instructions for use, packaging and user manuals into their designated language s. In these directives manuals are also discussed extensively. Product documentation and materials related to product safety. Learn here more about what a technical file is and how to create it. Only those product categories subject to specific directives that provide for the ce marking are required to be ce marked. Cemarking s impact upon user manuals the european new approach directives are the basis for ce conformite europeenne marking. 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. The ce marking has a height of at least 5 millimetres. There are 23 official community languages, used in the following member states. Ce marking does not mean that a product was made in the eea, but states that the product is assessed before being placed on the market.
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. For operations and programming of the robot controller, refer to the users manuals that come with the robot controller. A wellarranged and userfriendly document to match your company, product or brand. Furthermore, it must be controlled whether the frame number and craft identification number are the same as the ones given in the.
Safety, labelling, packaging and marketing rules for products imported into the eu, technical standardisation and conformity rules, ecolabel rules, check what requirement your product needs. The ce marking is also found on products sold outside the eea that have been manufactured to eea standards. The user manual as part of ce marking the european new approach directives form the starting point of the ce marking conformite europeenne. Technical file what is it and how to create it ce check. The in vitro diagnostic directive ivdd 9879ec published october 7, 1998 requires all noneuropean ivd manufacturers to obtain cemarking in order to. Ce marking indicates that your medical device complies with the applicable eu regulations and enables the commercialization of your products in 32 european countries. What is ce marking and what are its effects on translation.
Translate the manual if needed into the proper language check whether the ec declaration of conformity is available verify that the ce marking is applied. 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. Most manufactured products that are made in, or imported to, the european union must be ce marked. Ce marking translation requirements, polilingua ce marking. Apr 03, 2017 importing countries under ce marking require translation of labeling, instructions for use, packaging and user manuals into their designated language s. 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. Eu legislation that requires the ce mark to be applied to covered products also known as ce marking harmonisation legislation covers product. The user manual also plays an important role within the ce mark requirements. Depending on product, there are also special ce requirements for the user manual.
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 directives only within the scope of builtin equipment semifinished product. European ce marking and translation requirements language. Broadly, sections of documentation and materials related to safety must be translated. The european new approach directives are the basis for ce conformite europeenne marking.
The european union requires ce marking on specific products. At ce check, we will assist you in the creation of a technical file with all of your products ce marking documentation. You must make sure that your product complies with all the relevant requirements before affixing the ce marking to it. For information on the warranty, also refer to the users manual that come with the robot controller. Ce dedicated fasttrack and ce onsite fasttrack are not available for devices. After reading the above sentence you may find yourself asking, what is ce marking, and what. Some products are subject to several eu requirements at the same time. This manual describes only the items related to 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.
Action plan for the trading company and the place of the user manual even if a trading company is not regarded as a manufacturer, it still has its certain responsibilities in the field of the ce marking. Or perhaps you are looking for help with product certification such as the ce marking. Learn how to write a product manual that complies with all mandatory. Where to find the ce requirements for an user manual. Do you want a user manual that meets the legal requirements.
Directive 9342eec clearly states which items should be in the user manual, for example safety instructions. Manufacturers must clearly identify in the labeling, the directives with which the product complies. 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. So, no ce marks are affixed to the yamaha robot products. Ce marking, or ce mark, is a symbol placed on a product indicating that it has been certified to be sold in europe freely. This makes the ce marking recognizable worldwide even to.
Getting the ce mark is a complex procedure with lots of requirements regarding health, security, environment and consumer protection. A ce declaration of conformity also called a ce certificate, ec declaration of conformity or eu declaration of conformity is the document that shows that the product complies with the applicable legislation. Part 1 part 1 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. How to write a user manual when importing products to the eu. Here you will find the answers to the most frequently asked questions about ce marking. The contents of this manual must be made available to the qualified personnel and implemented. A wellarranged and user friendly document to match your company, product or brand. Eu machinery directive 200642ec translation requirements and trends as of january 1, 2015, the european union eu consists of 28 countries, over 500 million consumers who communicate in 24 different languages. Importing countries under ce marking require translation of labeling, instructions for use. This is an area where many manufactures get it wrong when ce marking a machine, but we will make sure you get it right. Our bulletin 1492 clearplot marking system is an xy plotter that provides a flexible marking tool for our terminal blocks in a compact design. As a notified body for nearly all eu product safety directives, our ce marking conformity assessment services provide you with the expertise you need to achieve compliance. Manufacturers are advised to check this with the national authorities concerned.
User manuals, product documentation and ce marking. According to the conformance website, this mark indicates that the item has been checked and it meets the standards of the cemarking directives, set by the eu. The penbased system provides durable marking on a variety of materials. The manual must tell the intended purpose of the product and any prohibitions and warnings. Aug 27, 2019 most manufactured products that are made in, or imported to, the european union must be ce marked.
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. By signing the declaration of conformity, the manufacturer or importer an importer is legally seen as the. Ce marking translation services language scientific. Please read this information before putting the instrument into operation and keep this manual accessible in the immediate vicinity of the device. Watch the 10 minutes video tutorial before reading this article. This process effectively permits manufacturers and importers identical access to every. All you will have to do is to upload your documents on our online service platform, and we will store and archive them for you. Instrktiv helps you with the certification of your product and creates your user manuals and technical documentation. The ce marking is placed onto the product or to its data plate. However, the other general parts of the user instructions must be supplied in the language of the end user.
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