The purpose of this users manual is to describe the requirements in form of data and documentation that the applicant has to compile in order to apply for the eu ecolabel for imaging equipment. Rather it is a reference document to be used as a guide. Switzerland accepts the ce mark for some products and turkey actually. 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. However, achieving compliance can be a complex process. There is not end date for the ce doc as far as the product remains the same and the directives are not changed. 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.
Depending upon the applicable ce marking directives that are relevant to your. Companies exporting their devices to international markets often underestimate the importance of translations. Affixing the ce marking is a sign that the product has been evaluated and found compliant with the eu requirements. Generally, the manufacturer is responsible for ce marking. Product documentation and user manuals can be difficult to use if not written precisely, concisely, and with consistent terminology in appropriate language.
It is a legal document that is mandatory for products that fall within the scope of. A user manual should be published in all three languages in order to. Six steps to ce marking trade commissioner service. Eu state they may agree to translate instructions on behalf of. Our team of experts understand all these requirements and can help and advise you throughout every step of the process, from identifying appropriate directives, to correct application of the ce mark on your product. Oct 08, 2012 the ce marking is at least 5 millimetres unless a larger minimum dimension is specified in the relevant directive. Eu foreign language labeling requirements ce mark, ce. In addition, this manual describes the requirements for demonstrating continued compliance once the label has been granted. The declaration of conformity is a document that needs to be signed by the manufacturer, wherein heshe declares that a certain product sold within the european union complies with the essential requirements of the relevant european product safety legislation. The commission guide to the machinery directive gives the following information. Below is a list of each member states general language requirements for labeling.
Directive 9342eec clearly states which items should be in the user manual, for example safety instructions. This information can also be found in specific country commercial guides ccg. As a rule, electrical, electromechanical, and mechanical products with a ce marking require the following to be translated into the national language of the european country to which the manufactures exports the products. Guide to ce marking for elite electronic engineering, inc. Many people think that the ce marking indicates the quality of the product. 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. 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. While ce marking requirements can seem overwhelming, gmed educates and reassures its clients on the process and provides direct access to a locallybased certification project manager, along with a dedicated production manager, available throughout the certification process. Language scientific provides ce marking translation services in over 215 languages. Cemarked products may be marketed across the eueea territory without additional testing. Products may not qualify for ce marking under all applicable directives at all times. 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. Manufacturers in the european union eu and abroad must meet ce marking requirements where applicable in order to market their products in europe. Most importantly, ce marking is a legal obligation derived from eu legislation that provides that certain types of products must comply with specific standards and requirements.
In addition, this manual describes the requirements for demonstrating continued compliance once the. Product manuals, or user guides, are not just nice to have. However, the other general parts of the user instructions must be supplied in the language of the end user. Although there are many similarities, the process of product. In this article, ferry vermeulen what is required regarding the user manual, as well as other ce requirements. Cemarkings impact upon user manuals the european new approach directives are the basis for ce conformite europeenne marking. And, poor translations pose a liability risk if a misunderstanding leads to misuse of your device by a patient or user. Ce marking is only obligatory for products for which eu specifications exist and require the affixing of ce marking. Ce marked products are entitled to free movement throughout the european market eu. The european union requires ce marking on specific products. Ce marking ce marking, also known unofficially as ce mark or ec mark, as shown on the top of this page, is a mandatory mark for many estimatively around 70% of the products sold on the efta plus european union eu single market including totally 30 eea countries and it is often referred as the trade passport to europe for noneu.
If a directive does not contain any requirements for a user manual, the economic operator can look into the relevant harmonised product standards. The ce marking is the manufacturers declaration that the product meets eu standards for health, safety, and environmental protection. The machinery directive ranslation requirements t are stated in annex i, section 1. First, it gives any importer an overview of all necessary steps to get an official ce marking on its product. Ce marking, or ce mark, is a symbol placed on a product indicating that it has been certified to be sold in europe freely. Below are references to translation requirements required by the ce marking process. Ce marking cemarking, also known unofficially as ce mark or ec mark, as shown on the top of this page, is a mandatory mark for many estimatively around 70% of the products sold on the efta plus european union eu single market including totally 30 eea countries and it is often referred as the trade passport to europe for noneu. Eu machinery directive 200642ec translation requirements and. User manuals, product documentation and ce marking. The ce marking requirements vary from directive to directive, and even within directives. The medical device regulation eu 2017745 is a set of requirements and processes for you as responsible. Certain of the member states with two or more official languages belgium, finland accept the use of one language only in areas where only that language is spoken.
Ce marking obtaining the certificate, eu requirements your europe. Eu machinery directive 200642ec translation requirements. Manufacturers must clearly identify in the labeling, the directives with which the product complies. There are 23 official community languages, used in the following member states. The mark consists of the ce logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. Determine the appropriate harmonised standard to instruct users.
The penbased system provides durable marking on a variety of materials. In order to ensure that your product is able to be widely continue reading ce marking. The instructions accompanying the machinery must be either original. 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. 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.
Manufacturers are advised to check this with the national authorities concerned. No particular languages are specified by the eu directives although it is. 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. The requirements mentioned above apply to a variety of different products, from medical devices. Global translation requirements for medical devices emergo. It has a specific format and must be kept in the correct proportion and have a. If an eu user imports a machine and instructions have not been translated into the language of their. Determine the eu requirements for user manuals as specified in the applicable, relevant ce marking product legislation. The ce marking requirement applies to products that may be hazardous for the user, including electrical appliances and recreational watercraft. In this article, well answer your biggest questions about requirements and best practices for translating device labeling and instructions for use ifu. Other member states with two official languages cyprus, malta and ireland accept the sole use of. Ce marking 101 frequently asked questions about ce.
Cemarkering certificering, euvoorschriften uw europa. The words original instructions must appear on the language. Cemarking indicates that your products comply with stringent eu product safety directives. 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. Language requirements are a national issue in which member states determine the appropriate languagelanguages necessary for labels on products in certain industries. 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.
Ce marking s impact upon user manuals the european new approach directives are the basis for ce conformite europeenne marking. The role of customs in maintaining safety, health and environmental requirements of products entering. 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. With the effectiveness of the ce marking directives, more products are now required to have the required marking in order for them to access the eu and efta markets. Badly written these can detract from the quality of your product, and even cause. The user manual is an important part of the ce marking requirements. The user manual also plays an important role within the ce mark requirements.
Importing countries under ce marking require translation of labeling, instructions for use, packaging and user manuals into their designated language s. Ce marking obtaining the certificate, eu requirements. How to write a user manual when importing products to the eu. European ce marking and translation requirements language. European market access with a trusted notified body. Low voltage directive 201435eu see 201435eu, article 6 9. One of the requirements in any eu directive is that a user should. Technical specifications and certification declaration of conformity. Our bulletin 1492 clearplot marking system is an xy plotter that provides a flexible marking tool for our terminal blocks in a compact design.
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. This is an area where many manufactures get it wrong when ce marking a machine, but we will make sure you get it right. Product documentation and materials related to product safety. Ce marking and the requirement for translations f2 tech notes. European union ce marking ce marking is not permitted for investigational devices but may be required by other directives. Global translation requirements for medical devices. In this part, ferry vermeulen and michael gerrits, describe the requirements in the eu. With the cemark you declare that the medical device is in compliance with all legal requirements of the european market. The important point to take is that the manufacturer is obligated to identify and comply with all applicable requirements, ce marking or others. What are the official languages of the european countries. When trading medical devices on the european market, obtaining the cemark is mandatory for every company or entity. Mar 07, 2018 many people think that the ce marking indicates the quality of the product.
Ce requirements for user manual certification company. Aug 23, 2011 most importantly, ce marking is a legal obligation derived from eu legislation that provides that certain types of products must comply with specific standards and requirements. You may have an excellent product and a top distributor, but if your translations of device labels and ifu are poor, it can hurt sales and damage the reputation of your company. By affixing the ce marking on protective equipment the manufacturer or importer ensures that the product comply with the basic health and safety requirements of the personal protective equipment regulation 2016425eu. The user of machinery may also request the manufacturer to provide the.
What is ce marking and what are its effects on translation. Ce marking translation requirements, polilingua ce marking. 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 marking directives. Please note that the blue guide is not a law like the directives. Ce marking for medical devices certification experts. 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. Most people usually refer to this document as the instruction booklet. Depending on the product, certain directives should be considered.
Austria german belgium dutch, french and german bulgaria bulgarian cyprus english and greek. When a product has a ce marking, the manufacture certifies that it meets the requirements of the eu directives and regulations applicable to it. You must make sure that your product complies with all the relevant requirements before affixing the ce marking to it. Typically, portions of documentation and materials related to safety must be translated. Ce marking and the requirement for translations f2 tech. It has a specific format and must be kept in the correct proportion and have a minimum height of 5mm. Getting the ce mark is a complex procedure with lots of requirements regarding health, security, environment and consumer protection. Ce marking indicates that your products comply with stringent eu product safety directives. Ce marking translation services language scientific. 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. Draw up the user manual and other technical documentation according to the eu requirements. There are different requirements for translations as specified in the directives. Ce marking 101 frequently asked questions about ce marking.
Title page, product name, type or code, trade name, image. 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. 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. The ce marking is a guarantee that the product conforms to the regulations of the. Many of these ce marking directives also set requirements for instructions for use. Create a user manual for the product and translate it to the appropriate language depending upon.
European rules for obtaining ce marking on products sold to eu member states or in the eea conditions and product requirements for the. One is that everyone talks about ce marking translation requirements without actually reading the specific directives that apply to their products. 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. Based on the classification of the personal protective equipment the conformity procedure is defined. Although there are many similarities, the process of product compliance in the us is slightly different from the process of eu compliance. 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. To qualify for ce marking, certain documents must be translated into the target countries designated languages. Some products are subject to several eu requirements at the same time. Whether its a large multinational project or a short document translation, we possess the expertise to. Ce dedicated fasttrack and ce onsite fasttrack are not available for devices. We work with you to ensure your documentation meets the requirements for ce marking compliance in your target countries.
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