Ce directives pdf active implantable medical devices directive 90385eec cableway installations directive 20009ec construction products regulation 3052011eu electromagnetic compatibility directive 201430eu environmental design for energyrelated products directive 2009125ec. A product might be in the scope of more than one directive and the ce mark affixed to the product by fulfilling the necessary requirements shows that the product is in. You can view the ec new approach directives guidance from the. Those directives extend the application of those agreements to national transport, in order to ensure the free movement of dangerous goods whilst enhancing transport safety. The ce regulations cover a broad range of products and set the requirements for the essential health and safety of union citizens as well as for product operability. Environmental design for energyrelated products directive 2009125ec. The ce marking represents a manufacturers declaration that products comply with the eus new approach directives. The ce marking requirements vary from directive to directive, and even within directives. The ce marking is easily visible, readable and permanent. The requirements for ce marking differ across all the directives and regulations and may also vary for different products within a directiveregulation.
The ce mark is affixed to the product as the final stage of this process and is effectively a statement from the manufacturer or importer that the process has been successfully completed and that the product meets the essential requirements of the relevant. 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 highest possible level of safety. Checklist for ce marking in the netherlands business. Comprehensive guidance on the implementation of eu product rules can be. Ce marking now provides product access to 27 countries with a population of nearly 500 million.
The bottom line is that ce marking means different things to different products under different directives. Therefore, it is the manufacturers responsibility to determine if a product requires a 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. The actual ce marking is the letters ce which a masymbol nufacturer affixes to. It was intended that, instead of various conformity symbols used in throughout eu, a unique eu symbol be used which designates conformity with the directives. Ce marking of construction products certifies why is ce marking compliance with construction products directive cpd or with the constructive product regulation cpr. Ce marking requirements vary from directive to directive, and even within directives. Please click the following links to learn more about every cemarking related european union directive, guidelines to directives, frameworks of implementation of directives, and agreements on mutual recognition of conformity assessment between european union and other countries such as usa, japan, canada, australia, new zealand and israel. Whilst the ecodesign directive appears to have a rather broad application, unlike other directives that mandate ce marking which prescribe specific requirements and standards with which a given type of product must comply, the.
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 requirements for ce marking differ across all the directives and may also vary for different products within a directive. 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. This makes the ce marking recognizable worldwide even to people who are not familiar with the european. Please click the following links to learn more about every cemarkingrelated european union directive, guidelines to directives, frameworks of implementation of directives, and agreements on mutual recognition of conformity assessment between european union and other countries such as usa, japan, canada, australia, new zealand and israel. Ce marking internal market, industry, entrepreneurship and smes. Our guide to navigating the ce marking process is organized by directives. Please find below a list of the ce marking directives and regulations european union directives regulations that require the affixing of a ce mark to the products covers by them. 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. Directive 200642ec of the european parliament and of the council of 17 may 2006 on machinery, and amending directive 9516ec description. Thirdparty testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturers unverified claim is all thats asked for. Download the most important ce product guidelines here. The ce mark is affixed to the product as the final stage of this process and is effectively a statement from the manufacturer or importer that the process has been successfully completed and that the product meets the essential requirements of the relevant ce marking directives. Ce marking is still a somewhat daunting and confusing procedure to the uninitiated, but the more you are involved the clearer it gets.
Please click the following links to learn more about every cemarkingrelated european union. New ce marking directives for electrical, electronic and telecommunications industries more. However overtime the directive is now fairly redundant as all of the directives mentioned have either been superseded or amended to include the ce marking requirement along with the details of affixing the ce mark itself. Rules governing the affixing of the ce marking should be laid down in this directive. These directives not only apply to products within the eu but also for products that are manufactured in or designed to be sold in the eea. If the ce marking cannot be affixed to the product itself, you can affix it to the packaging if there is any, or to any accompanying documents. Ce marking is a part of the eus harmonisation legislation, which is mainly managed by directorategeneral for internal market, industry, entrepreneurship and smes. Please click the following links to learn more about every ce marking related european union directive, guidelines to directives, frameworks of implementation of directives, and agreements on mutual recognition of conformity assessment between european union and other countries such as usa, japan, canada, australia, new zealand and israel.
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. New ce marking directives for electrical, electronic and telecommunications industries. General principles governing the ce marking are set out in regulation ec no 7652008. Ce marking assistant, your declarations of conformity online. Machinery directive 200642ec your guide to ce marking. The blue guide on the implementation of eu product rules new edition 2016 the european union published in 2016 the new edition of the blue guide, the main reference for understanding the rules relating to the activities of ce marking of products. There is a series of steps that manufacturers must follow. In order to determine if your product needs a ce marking, you should look in each directive that you judge as related to your product. The ce marking for restriction of hazardous substances is managed by directorategeneral for environment. Download pdf rendition european commission europa eu. Learn which ones apply to your products and how to comply with the requirements and paperwork. Those directives are considered adequate to provide appropriate protection where the risk due to pressure associated with such equipment remains small. There are, however, fundamentals that are common across most directives.
Please find below a list of the ce marking directives and regulations european union directivesregulations that require the affixing of a. One of the key components of new approach ce marking directives are essential requirements. The ce marking is the manufacturers declaration that the product meets the requirements of the applicable ec directives. Ce is sometimes indicated as an abbreviation of conformite. 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.
If your product is subject to several eu directives regulations which require a ce marking to be affixed, the accompanying documents must indicate that your product conforms to all applicable eu. This is a declaration by the manufacturer or by an importer located within the european economic area that the product complies with the essential health and safety requirements of the relevant eu directives. Under each directive, we explain the route to ce marking certification stepbystep and in one place. It simplifies the task of the market surveillance, but also informs you consumer, safety advisors, purchasers, that. Ce marking can in simple terms be described as a passport or a license to sell allowing free movement within the internal market of the european union. Frequently asked questions about ce marking or questions. For details, refer to ce conformite europeenne marking directive. All gloves of intermediate and complex design must now. Ce marking is currently required for many products sold in europe, yet many u. Machinery directive handbook ce marking for machinery. Since this regulation is a measure for implementing the ecodesign directive 2009215ec. Ce marking what it means for ppe what is the meaning of a ce mark. The ce marking directive 9368eec ce marking association. Cemarking services from sgs meet the compulsory product safety directives you need to trade in the eu with effective conformity assessment services from a notified body.
Each legislation directive or regulation has a scope, which describes in detail the types of products to which it applies. Welcome to our publication of exporting to europe and ce marking. Manufacturers in the european union eu and abroad must meet ce marking requirements where applicable in order to market their products in europe. Download declaration in word or pdf format, with your logo. Oct 08, 2012 ce marking is mandatory, but only for those products which are covered by the scope of one or more of the new approach directives. In conclusion the ce marking directive was responsible for the requirements of attaching a ce mark to product. Ce marking generally requires a technical construction file, which forms the basis for the declaration of conformity. When the ec directive takes effect, it will actually be impossible to export or sell the products covered by this directive in the eu area. 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 ce marking is only required if a product is covered by one or more ce marking directives or regulations. At4 wireless launches the english version of its web site about ce marking. Ce marking obtaining the certificate, eu requirements. Ce marking ce marking is stuck on the products which have cleared the mandatory safety requirements stipulated in ec directives.
Ownbranding an item normally makes you the manufacturer for the purpose of cemarking. If you want to trade in the eu, cemarking is a mandatory conformity mark required for a wide variety of products. The ce marking is placed onto the product or to its data plate. Together with many other directives, the cpd and cpr helps to realise the european single market by setting standards that remove tech nical. The ce marking is also found on products sold outside the eea that have been manufactured to eea standards. Each legislation directive or regulation has a scope, which describes in detail the types. If a european product safety directives applies to your products and you want to continue to.
Find the eudirectives and harmonised standards that apply. If your product is subject to several eu directivesregulations which require a ce marking to be affixed, the accompanying documents must indicate that your product conforms to all applicable eu. On these products, the ce mark is accompanied by the notified body number below the ce symbol. This makes the ce marking recognizable worldwide even to those unfamiliar with the eea. Atex and gas, also require that ce marking for certain product types is supported by mandatory certification from a qualified body.
Active implantable medical devices directive 90385eec. Machinery directive handbook ce marking for machinery directive 9837ec the machinery directive 9837ec is one of the most important european directives for manufacturers of industrial equipment. The machinery directive allows most of the manufacturers to selfcertify their products. Unfortunately, there is no comprehensive list of the products that require a ce marking. The new ce marking new approach directives were intended to open european markets to the free movement of goods, but manufacturers must still be aware of national deviations and interpretations that may exist. Ce marking for european directives the language center. Ce marking is a mark of conformity with the new approach directives of the eu which shows the product on which it has been affixed is safe for the purposes of environment. The ce marking has a height of at least 5 millimetres. 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. There are over 20 different new approach directives. The important point to take is that the manufacturer is obligated to identify and comply with all applicable requirements, ce marking or others. Ce marking ce marking is a health and safety symbol, which is implemented within the framework of new approach constituted by european union eu in 1985, so as to ensure free movement of goods. Such equipment which is covered by directive 200868ec. The term manufacturer is defined quite widely and can include those importing products made outside europe and persons making items for their own use.
1330 267 1565 479 728 1669 1399 394 262 759 429 749 1384 1549 1619 583 530 1592 842 955 663 1584 1568 400 921 861 532 671 1330 1308 1300 323 522 732 560 221 1335 1109 130 513 364 1482 915 165 640 601 515