The technical file is one of the corner stones of the ce marking process. The directive requires notified bodies to take into account any premdd device and system approvals held by a manufacturer for his device or quality system prior to the directive. The exporter or authorized representative must be able to provide the supporting paperwork to prove ce marking. Welcome to our publication of exporting to europe and ce marking. The ce marking is the manufacturers declaration that the product meets the requirements of the applicable ec directives. Step 1 determine all applicable requirements directives frequency bands conformity assessment module harmonized standards step 2 perform testing and analysis effective use of spectrum emc low voltage directive step 3 prepare technical file step 4 label device and issue the doc step 5 maintain technical file and. 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. However overtime the directive is now fairly redundant as all of the directives mentioned have either been superseded or amended to include the ce marking requirement along with the details of affixing the ce. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy.
Celab can accomplish all the required tests in order to affix the ce marking related to emc, lvd, red, mdd, machines and many. Directive 201435eu of the european parliament and of the council. The ce marking is only required if a product is covered by one or more ce marking directives or regulations. If a european product safety directives applies to your products and you want to continue to.
From stepbystep guides on the ce declarations of compliance to discussion forums on ce mark technical file requirements, your ce marking. Directive or is not ce marked, or has been rebranded with a suppliers own name, must also take on the duties of the. Celab can accomplish all the required tests in order to affix the cemarking related to emc, lvd, red, mdd, machines and many others. Technical file for machinery the technical file must demonstrate that the machinery complies with the requirements of this directive. Ce marking is a process that applies to a wide variety of products and one which manufacturers located in the eu or importers of goods into the eu must complete. Complies with the applicable ehsrs of the 200642ec machinery directive and its amending directive we declare the technical file. While a manufacturer does not need to buy these documents to meet the essential requirements of the directive, european authorities often use them to determine.
Depending on the product, ce marking may be as simple as formulating a technical file, or as complex as having to submit your products to regular independent scrutiny. What are the language requirements for the technical file. We can help you to meet the requirements of all of the relevant product legislation. Ce marking now provides product access to 27 countries with a population of nearly 500 million. The social cost of the large number of accidents caused by the use of machinery can be reduced by. The ce marking is mandatory for all products that fall into one of the community directives relating to the ce marking in the european union member countries. Visit the ce mark directive ce marking legislation group on. Those documents contain information regarding all steps a product has taken to conform with ce marking.
Tuv rheinland supports wind turbine manufacturers with ce marking certification against the iec 61400 series. The exporter must maintain a file called a technical file containing the paperwork that proves conformity to the ce marking directive s covering its product. Ce marking on a product is the manufacturers declaration that the product complies with the essential requirements of all the directives that apply to it. Please find below a list of the ce marking directives and regulations european union directivesregulations that require the affixing of a ce mark to the products covers by them. Step 1 determine all applicable requirements directives frequency bands conformity assessment module harmonized standards step 2 perform testing and analysis effective use of spectrum emc low voltage directive step 3 prepare technical file step 4 label device and issue the doc step 5 maintain technical file. The actual ce marking is the letters ce which a masymbol nufacturer affixes to certain products for access to the european market consisting 32 eu countriesof and also referred to as the european economic area or eea. Keywords ce marking, wind turbines, iec 61400, wind turbine manufacturers, ce marking certification, tuv rheinland created date. Ce mark directive ce marking legislation element14. This documentation should prove compliance with the directive s and should be stored within the european union for about 10 years after the last product has. 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. A short guide to the law and your responsibilities when. 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.
Do prepare one technical file to cover a line or family of machines. Ce marking on a product is the manufacturers declaration that the product complies with the essential requirements of all the directives. All european ce marking directives oblige the manufacturer to draw up a technical file or in the directives youll also find the term technical documentation. Low voltage lvd directive 201435eu scope the purpose of this directive is to ensure that electrical equipment on the market fulfils the requirements providing for a high level of protection of health and safety of persons, and of domestic animals and property, while guaranteeing the functioning of the internal market. 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. Product directives and regulations ce marking association. If one notified body has typecertified a product module b, can the manufacturer turn to another. Manufacturers internal market, industry, entrepreneurship. The ce marking is placed onto the product or to its data plate. Atex and gas, also require that ce marking for certain product types is supported by mandatory certification from a qualified body. Ce marked products are entitled to free movement throughout the european market eu. Several ce marking directives require that the technical file is written in an official language of the member state where the procedures are to be carried out, or in which the approved certification body socalled notified body is established, or in a.
The important point to take is that the manufacturer is obligated to identify and comply with all applicable requirements, ce marking. The technical file should prove your products compliance with the ce directives. The ce marking association are specialists in european product compliance. Technical file template ce marking services ce check. Ce marking internal market, industry, entrepreneurship. Comprehensive guidance on the implementation of eu product rules can be. Ce marking is a key indicator of a products compliance with eu legislation. When the ec directive takes effect, it will actually be impossible to export or sell the products covered by this directive. Where a directive or regulation requires products or systems to be independently tested, certified or inspected you will need to use the services of a notified. Ce marking is a part of the eus harmonisation legislation, which is mainly managed by directorategeneral for internal market, industry, entrepreneurship and smes.
According to the directive 9368eec in the future the ce marking consists of the letters ce with the following face. Understanding the machinery directive 2006 42ec the directive has been put in place because. Manufacturers in the european union eu and abroad must meet ce marking requirements where applicable in order to market their products in europe. 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 s involving the product isare determined. Download the most important ce product guidelines here. The requirements for ce marking differ across all the directives and regulations and may also vary for different products within a directive regulation.
Ce is sometimes indicated as an abbreviation of conformite. Machinery directive handbook ce marking for machinery. Machinery directive 9837ec cemarking what manufacturers. Please find below a list of the ce marking directives and regulations european union directivesregulations that require the affixing of a ce mark to the products. Ce marking generally requires a technical construction file, which forms the basis for the declaration of conformity. Do not create duplicate files to support your technical file. 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. Celab performs voluntary inspection activities on technical construction files to check their contents. Ce marking internal market, industry, entrepreneurship and smes. 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. Compliance with the essential requirements of the eus machinery directive is required of all machinery and machine products destined for the eu market.
The mark is mandatory for products which fall under one of 24 european directives. Depending on the specifics of the directive that covers your product, you must make sure that. The machinery directive 200642ec became applicable on 29 december 2009, superseding the machinery directive 9837ec. This documentation should prove compliance with the directive. The mark must be at least 5 mm high, but this requirement is waived for small products under those directives which require the logo to. The ce mark means that the manufacturer takes responsibility for the. Are there any size requirements on the ce logo itself. The ce marking is easily visible, readable and permanent. Tuv sud is an eu notified body and can evaluate machinery for compliance with the requirements of the machinery directive 200642ec.
Ce marking ce marking is stuck on the products which have cleared the mandatory safety requirements stipulated in ec directives. Products subject to the provisions of the directives as if new products and products which have undergone a change significantly must bear ce marking. If requested by authorities, you should be able to provide the technical documentation and a copy of your products ce declaration of conformity within a short time frame. Ce marking requirements vary from directive to directive, and even within directives.
Online ce marking software follow as a manufacturer or importer, you must compile the technical documentation detailed in the eu directive s concerning risk analysis and product compliance. Machinery directive 200642ec ce marking machines uk. Depending on the product, ce marking may be as simple as formulating a technical file. The ce marking requirements vary from directive to directive, and even within directives. Accreditation and market surveillance relating to the marketing of products. Oct 08, 2012 the ce marking is at least 5 millimetres unless a larger minimum dimension is specified in the relevant directive. Technical file what is it and how to create it ce check. You can find the full text on the website of the european union at the following. Ensure that your product complies to these directives by testing or by asking your supplier the required documents to prove compliance. The backgroundgrid should be considered only as an aid and is not part of the ce marking.
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. Only those product categories subject to specific directives that. Do use your iso 9000 document control system to index your technical files existing supporting documents. 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. We participate in the ce marking process working with machinery manufacturers and distributors from the design phase risk evaluation of the machine to the equipments rollout evaluation of the technical file for ce. For details, refer to ce conformite europeenne marking directive. The machinery directive allows most of the manufacturers to selfcertify their products. The ce marking, indicating the conformity of electrical equipment, is the visible consequence of a whole process comprising conformity. 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. Rohs directive 201165eu eu compliance services, inc. Therefore, it is the manufacturers responsibility to determine if a product requires a ce marking. The ce marking has a height of at least 5 millimetres. Applicable ec directives will change depending on the type of product.
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. 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. Ce marking for wind turbines according to iec 61400 author. Those documents contain information regarding all steps a product has taken to conform with ce marking requirements. Directives, covering design and manufacturing of the product, is accepted by the entire. Ce marking generally requires a technical construction file. The ce marking for restriction of hazardous substances is managed by directorategeneral for environment. For each directive is available the list of harmonized standards to which the product should be subject, so it is. Thirdparty testing, systems assessment and technical file assessments can be mandatory, but sometimes the manufacturers unverified claim is all thats asked for.
Meeting both of these requirements can be costintensive and timeconsuming. As a manufacturer, you should store it within the eu for about 10 years. The ce marking directive 9368eec ce marking association. Technical file information all ce marking directives require the manufacturer of the product to create a technical file which should contain the information required to show that the product properly complies with the requirements of the directives which apply to it. Information on the atex directive 949ec can be found here. Ce marking is currently required for many products sold in europe, yet many u. Directive 9723ec should therefore be adapted to that decision. Our machinery directive handbook facilitates the ce marking of industrial equipment by acting as a single point of reference for understanding and complying with the machinery directive. The machinery directive is eu legislation that is implemented in order. Find out if your product requires ce marking and which directives apply to your product. The technical performance of ppe is specified by european norms, harmonised standards or in a technical file. The rohs directive is a ce marking directive, and conformity to this directive must be stated on the equipments declaration of conformity.
We offer a comprehensive range of services for the implementation of ce marking. Where the full quality assurance procedure referred to in article 123c and 124b has been applied, the ce marking must be followed by the identification number of the notified body. 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. To create a technical file, the manufacturer has to collect and put together all documents relevant to the ce marking process of the respective product. Unfortunately, there is no comprehensive list of the products that require a ce marking. In conclusion the ce marking directive was responsible for the requirements of attaching a ce mark to product. Download declaration in word or pdf format, with your logo. Thirdparty testing, systems assessment and technical file assessments can be mandatory, but sometimes the. We participate in the ce marking process working with machinery manufacturers and distributors from the design phase risk evaluation of the machine to the equipments rollout evaluation of the technical file for ce certification, whatever the type of machine.