The technical file must contain all information that is necessary to demonstrate the conformity of the product to the applicable requirements. Products not covered under a new approach directive do not require ce marking. There are a number of ce marking requirements to keep in mind. Ce marking 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. These requirements, known as essential requirements, are listed in annex i of the ivd directive. The ecodesign directive for energyrelated products new. Ce marking obtaining the certificate, eu requirements. Compile a technical file which contains all these documents to prove compliance. For a detailed overview, please consult directive 9879ec. Ce marking internal market, industry, entrepreneurship. The ce marking itself is not meant to provide details about the product to surveillance authorities. Technical file what is it and how to create it ce check.
It is illegal to place a ce mark on a product that is not covered by a directive. The placing of a ce mark for example, if a business wishes to market its products in europe and those products are covered by the relevant eu legislation that prescribes ce marking, then a ce mark must be placed on such products as part of compliance with the applicable legal requirements. No 7652008 of the european parliament and of the council of 9 july 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing regulation eec no. It has a specific format and must be kept in the correct proportion and have a. Fees be aware that you may file only one application with one notified body. Frequently asked questions about ce marking or questions. The initials ce are in the standard, predefined form. If you wish to reduce or enlarge the ce marking on your product, you. The added value of ce marking is that all eu countries must allow the selling of construction products bearing. The ce marking for ppe is compulsory since 1 july 1995. 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. Ce marking is currently required for many products sold in europe. Ce marking is a mandatory conformity marking for certain products sold within the european economic area eea since 1985. The legal instrument laying down the requirements for ce marking of personal protective equipment ppe is the european directive 89686eec.
Protection requirements products shall be so designed and manufactured, having regard to the state of the art, as to ensure that. 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. It indicates to the appropriate bodies that the product may be legally offered for sale in their country. Qa and regulatory team members are always confused or find it difficult in identifying the required number of technical files for the products planned for european ce marking. A set of operating instructions is included, and a declaration of conformity is available. Download declaration in word or pdf format, with your logo. A company ltd technical file no 1234tf1 pressure equipment. The machine directive, however, does offer more detailed information on how to meet safety requirements than most other ce marking directives.
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. The ce marking that appears on many different products from teddy bears to 30ton hydraulic presses is a important feature of a product and indicates it complies with the detailed essential requirements for that type of products. The ce marking is placed onto the product or to its. Pressure vessel rev no 1 job no 1234 issuing authority. Technical file template ce marking services ce check. The directives require for many products that a technical documentation technical file be prepared by the manufacturer. Best consultant for medical device technical file i3cglobal. Ce marking 101 frequently asked questions about ce marking. 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 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. Although the ce mark is the responsibility of the manufacturer or. The individual directives have requirements on the ce mark.
The requirements range from knowing and complying with the directives to affixing the ce marking the right way. Pumps driven by ac or dc motors or diesel engines for use in zone 2 areas above ground must be designed to satisfy the requirements for category 3 and a european notified body need not be involved. The white paper then discusses the process for sourcing compliant marking. The last step of the ce marking process is affixing the ce mark to the product. An overview of the eu low voltage directive 8 ce marking if your product is compliant with all of the directives that apply to it, then you can make a declaration of conformity doc and apply ce marking to your product and its packaging.
Information on the atex directive 949ec can be found here. Ce marking technical file for sensorex corporation page 9 of 10 annex ii essential requirements in the following text the word product also means component, equipment, apparatus, assembly and machine 1. Technical documentation esrs for ce marking of pressure equipment manufacturer. If your product is subject to several eu directivesregulations which require a ce marking to be affixed, the accompanying documents must. 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. The ce marking is also found on products sold outside the eea that have been manufactured to eea standards. The letters ce appear on many products traded on the extended single market in the european economic area eea. This makes the ce marking recognizable worldwide even to people who are not familiar with the european economic. Ce marking is compulsory for most products covered by the new approach directives. The european directive 89686eec lays down the requirements for ce marking of personal protective equipment ppe.
Ce marking can, in simple terms, be described as a passport or license to sell allowing free movement of goods within the internal market of the european. 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. Eniso 12100 assessment of the risks engineered with safexpert ra software. The ce marking has a height of at least 5 millimetres. They signify that products sold in the eea have been assessed to meet high safety, health, and environmental protection requirements. Products that comply with the ce marking requirements benefit from the following. Ce marking process without the requirement to have the assessment. This makes the ce marking recognizable worldwide even to those unfamiliar with the eea. What is the meaning of a ce mark on personal protective equipment.
Those documents contain information regarding all steps a product has taken to conform with ce marking requirements. Accordingly, the manufacturer of record has the responsibility to develop a technical file, also called a technical construction file. The need for ce marking new approach directives eliminate differences in laws therefore remove nontariff barriers to trade prescribe the essential health, safety, and performance requirements member states transpose directives and harmonized standards into their national requirements absence of third party intervention. The ecodesign directive for energyrelated products new ce marking directive taking the lead for erp intertek is the worlds leading erp authority providing easy and costefficient erp compliance evaluations and declarations for mandatory ce marking requirements. It is advised to remember that technical file or technical documentation is all about your device to. 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. Fulfills the requirements of relevant european product directives. Product documentation technical file example medcert.
Low voltage directive 201435eu your guide to ce marking. Ce marking obtaining the certificate, eu requirements your europe. Technical documentation esrs for ce marking of pressure. 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. The ce marking has been put in place to ensure products on the market comply with the directives of the eu.
Manufacturers in the european union eu and abroad must meet ce marking requirements where applicable in order to market their products in europe. Introduction for lighting products, the ce mark of the european communities signifies the manufacturers or responsible vendors selfdeclaration of conformity with the following directives and regulations. In decision 90683eec of december 1990 the council established that the essential objective of a conformity assessment procedure is to enable the public authorities to ensure that products placed on the market conform to the requirements as expressed in the provisions of the directives, in particular with regard to the health and safety of users. The ce mark is the responsibility of the manufacturer or the exporter to the eu, who must declare that the product complies with all relevant directives. And are there any other requirements that you should keep in mind. When you buy a new phone, a teddy bear, or a tv within the eea, you can find the ce mark on them. Environmental protection single, harmonised set of technical requirements free movement of goods and services level.
A ce mark is a symbol that must be affixed to many products before they can be sold on the european market. 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 ce marking must consist of the initials ce, both letters should have the same vertical dimension and be no smaller than 5mm unless specified differently in the relevant product requirements. The low voltage directive defines which products fall within its field of application, it provides the essential safety requirements that electrical equipment and components covered by it must comply with, and it outlines the conformity assessment procedure the manufacturer must apply in order to ensure compliance with the essential requirements. Directive 9879ec on in vitro diagnostic medical devices ivds specifies general requirements the product must meet in order for the manufacturer to affix the ce marking. The provisions regarding the ce mark compliance s documentation are a part of the new approach directives. By placing the ce marking on a product a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve ce marking. The manufacturer is thus ensuring validity for that product to be sold throughout the eea. Ce marking allows the product to freely circulate throughout the european economic area. Imagine this your company has developed a new product using cuttingedge technology.
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