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