Checklist for ce marking in the netherlands business. 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. Ce is an acronym for conformite europeenne, which means, conforms to european legislation. Part of the ce marking process is drafting the instruction for use hereafter. Within a couple of hours your manual can be printed for your client. Eu machinery directive 200642ec translation requirements and trends as of january 1, 2015, the european union eu consists of 28 countries, over 500 million consumers who communicate in 24 different languages. Determine the appropriate harmonised standard to instruct users. 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.
By affixing the ce marking on atex the manufacturer or importer confirms that the equipment meets essential health and safety requirements of atex. For example with photos and pieces of text that you have to include in your user manual or to place on your product, etc. Depending on product, there are also special ce requirements for the user manual. There are over 20 different directives that define ce marking requirements for different product classes. Ce marking merely states that the product is assessed on safety, health and environmental protection requirements before being placed on the market and thus satisfies the legislative requirements e. One is that everyone talks about ce marking translation requirements without actually reading the specific directives that apply to their products. Importing products from china to the european union. Some products are subject to several eu requirements at the same time. The manual provides users with instructions on the usage of the product, particularly in. Ce mark guide for electronic hardware products emc fastpass. The new approach directives require that the manufacturer compiles technical documentation technical file with information to demonstrate compliance with the applicable requirements. Article 14 indicates the general principles of the ce marking, and highlights that. If you prefer not to have your ce file online, we also have editable ce files that you can download and use entirely offline.
The user manual is an important part of the ce marking requirements. Simple and practical explanation about ce marking of machinery and assemblies. Ce marking also supports fair competition by holding all companies accountable to the same rules. Depending on the product, importers are required to ensure full compliance with all relevant ce directives a process that is far more complex than requesting a test report from your supplier.
An essential ce marking checklist priority, in this regard, is translation of relevant documentation. The ce marking and the ua class identification label shall also be affixed visibly and legibly to the packaging and to the users manual. Previously, enforcement only targeted eubased importers. User manual template medical certification experts. Note this product complies with the weee directive 200296ec marking requirements. Ce requirements for user manual certification company. Ce marking is a mandatory standard requirement for the vast european single market. The ce marking and assorted documents like the declaration of performance dop show that the manufacturer has researched the attributes of a product according to the relevant standard or standards and maintains them there. 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. Informational guide to ce marking requirements nts. Some directives specify the content of instructions for users and others such as installers in significant detail. Compliance the user instructions function is to explain to the user how a product can be used safely and correctly. Ce marking translation requirements, polilingua ce marking.
Ce mark for drones drones rpas alter technology group. 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. Ce marking for european directives the language center. As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing ce marking for your product, regardless of whether you outsource any. The ce marking is placed onto the product or to its data plate. Ce marked products are entitled to free movement throughout the european market eu. Many of these ce marking directives also set requirements for instructions for use. In addition, asus disclose the relevant information based on regulation requirements.
Facilities, which have commenced operation after 1994, must meet the. The important point to take is that the manufacturer is obligated to identify and comply with all applicable requirements, ce marking or others. In the ce tool you will find a list with requirements for the user manual. Eu machinery directive 200642ec translation requirements.
It is proof of a products compliance with the european legislation on product safety. Requirements for ce approval facilities, which have commenced operation after 1994, must meet the requirements detailed in the machinery 200642ec. The ifu medical devices template is an ms word template, that contains all mandatory elements to create your own ifu for medical device. Oct 08, 2012 the ce marking is at least 5 millimetres unless a larger minimum dimension is specified in the relevant directive. Watch the 10 minutes video tutorial before reading this article. Eu foreign language labeling requirements ce mark, ce. Ce marking obtaining the certificate, eu requirements. The ce marking shall be followed by the specific marking of explosion protection ex, and may be followed by any other mark indicating a special risk or use, as it mentioned in atex 114 directive. What details must be included in the tf depends on the nature of the product and what, from a technical perspective, is considered necessary to demonstrate that the product meets the essential requirements of the relevant directive. 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. Cemarking indicates that your products comply with stringent eu product safety directives. 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.
Ce mark for drones, is according to the last regulatory proposal published by easa npaa, 2017. The user manual template is an ms word template, that contains all mandatory elements to create your own user manual for machinery. May 15, 2018 ce marking on medical devices indicates that they comply with the applicable european legislation with regard to product safety. Read more about the rules and regulations that apply for ce marking. Instructions for use and medical devices ce mark medical. Ce marking and compliance technology international group. The apparatus is marked with this symbol when the user should refer to the instruction manual in order to protect risk of harm to the operator and. In the ce tool you will find a list of requirements for the user manual. Save money with buying the iso standard 10240 for writing owners manuals. You can use the template to create instructions that comply with the ce marking requirements, the machinery directive, the en 82079 standard for user instructions and the ansi z535. These 28 countries have adopted into national law the machinery directive 200642ec. The declaration of conformity is issued at the end of the ce marking process, and it only applies to products falling within the scope of one or more of the ce directives.
If you already have a manual, check whether it meets these requirement. Depending on the product, certain directives should be considered. Cemarkering certificering, euvoorschriften uw europa. Since 1985, any product sold in the european union must bear the ce mark certification. And if not, you can use this file as a guide for drawing it up. The process can often be quite confusing and complex and can take up a lot of a companys invaluable time. Ce marking of machines and facilities process engineering as. Although there are many similarities, the process of product. The ce marking has a height of at least 5 millimetres.
Accelerate the ce approval of your boat many ce approvals are never finalized due to the owners manual. 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. That said, things are changing as the eu is flooded by noncompliant and unsafe products originating from cross border ecommerce companies. Ce marking on medical devices indicates that they comply with the applicable european legislation with regard to product safety. Cemarkings impact upon user manuals the european new approach directives are the basis for ce conformite europeenne marking. Directive 9342eec clearly states which items should be in the user manual, for example safety instructions. User manuals, product documentation and ce marking. Each legislation directive or regulation has a scope, which describes in detail the types. 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.
You must make sure that your product complies with all the relevant requirements before affixing the ce marking to it. The ce marking and, when relevant, the ua class identification label, shall be affixed visibly, legibly and indelibly to the product, unless that is not possible or not warranted on account of the nature of the product. Ce marking is not required when selling into the united states, australia or any other market. Ce marking is only obligatory for products for which eu specifications exist and require the affixing of ce marking. Ce marking indicates that your medical device complies with the applicable eu regulations and enables the commercialization of your products in 32 european countries. If a directive does not contain any requirements for a user manual, the economic operator can look into the relevant harmonised product standards. If you also make other products that are subject to different requirements, the. Ce marking is the manufacturers declaration that the product meets the requirements of relevant directives. A ce marking also known as a ce mark is required for all manufacturers who sell products in the european economic area eea. In this article, ferry vermeulen what is required regarding the user manual, as well as. The ce marking is easily visible, readable and permanent. We conduct audits under the scope of the applicable directives and compile the technical file for your product or machinery.
The marking is obligatory, and it shall be affixed to products if this is required by the relevant directive. Ce marking is a complex procedure with lots of requirements. The user manual also plays an important role within the ce mark requirements. The ce marking is a european proof of conformity and is also known as trade passport to europe that allows manufacturers and exporters to circulate products freely within the eu. In this article, ferry vermeulen what is required regarding the user manual, as well as other ce requirements. Where to find the ce requirements for an user manual. By affixing the ce marking to a product, a manufacturer declares that the product meets all the legal requirements for ce marking and can be sold throughout the eea. The ifu provides general information on the use of the medical device as well as safety information including warnings. 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. Ce marking and labelling finnish standards association sfs. Determine the eu requirements for user manuals as specified in the applicable, relevant ce marking product legislation. Getting the ce mark is a complex procedure with lots of requirements regarding health, security, environment and consumer protection. Product documentation and user manuals can be difficult to use if not written precisely, concisely, and with consistent terminology in appropriate language. Ce marking allows for the ce symbol to be attached to a product and is sometimes referred to as a european trade passport since it allows companies to freely sell their products throughout european 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. Importing countries under ce marking require translation of labeling, instructions for use, packaging and user manuals into their designated. Draw up the user manual and other technical documentation according to the eu requirements. A valid ce mark is a legal requirement for supplying products to europe. In order to ensure that your product is able to be widely continue reading ce marking. For this, a userce needs to click on apply for provisional certificate link on home page screen. 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. You can use the template to create ifu that complies with the ce marking requirements, the medical device regulationmedical device directive, the en 82079 standard for user instructions and the ansi z535. 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. Other products shall not be labelled with a ce marking. The european new approach directives are the basis for ce conformite europeenne marking.
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. Technology international has been providing ce marking and compliance support for mechanical, electrical, electronic and radio systems intended for supply in europe since 1991 and has dealt with over 10,000 products. Therefore, the end user become classed as the manufacturer and assumes liability for the facilitys compliance with the requirements necessary for ce approval. 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. However, achieving compliance can be a complex process. The white paper then discusses the process for sourcing compliant marking. 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.
1382 1623 1507 1567 75 560 1357 422 472 882 1108 1329 806 367 1565 995 433 334 177 451 216 770 1532 528 541 270 1215 618 778 1251 1309 1351 193 4 633 722 377 185 892 659 625 219 140 5