In addition, this manual describes the requirements for demonstrating continued compliance once the label has been granted. The european new approach directives form the starting point of the ce marking. User interface can be in english, provided that the information required for the safe use of the product is included in czech language into user manual or into another document available for the user. Exemption from the language requirement in specific cases, the danish medicines agency may grant exemption from the language requirement and allow the information to be written in another language. It covers devices used widely, not those only used by health care professionals.
Eu ecolabel user manual lubricants commission decision eu 20181702 establishing the eu ecolabel criteria for lubricants version 1. To identify the requirements from the harmonised standards. Use of symbols to indicate compliance with the mdr. These 28 countries have adopted into national law the machinery directive 200642ec. The directives outline the safety and performance requirements for medical devices in the european union eu. D to understand, software user manuals are sometimes written from the point of view of a developer rather than a user. Developing a products manual in english only may complete the manufacturers requirements for iec 606011, but not for the national regulations. For products sold in france, the ce marking should be translated in.
In an effort to make each step of the process as transparent as possible, the european commission introduced a series of mandatory guidelines for products seeking to enter the eu market one of which directly relates to the language requirements for a products instructions for use. Current eu law requires albeit based on different legal regulations both the. Flamability european requirements there is no eu standard or requirement to indicate the flammability of a fabric. European translation requirements english to german. Eu translation requirements glossa group gmbh multi. For example, under article 4 of the mdd, each member state may require product labeling to be in its national languages. In addition, this manual describes the requirements for demonstrating continued compliance once. We have developed user manual templates for medical devices eu and us that contain all legal content. Language requirements are a national issue in which member states determine the appropriate language languages necessary for labels on products in certain industries. Creating instructions for use ifu for medical devices requires quite a lot of responsibility in fact, you need to combine your techcomm skills with project management, administrative and legal skills. Get smooth, soft, youngerlooking skin with these skin tips from top dermatologists. Meet requirements of eu medical device directives bsi. Ce marking translation requirements, polilingua ce marking. As an example, the 200948ec toys directive gives the following requirement.
Jun 23, 2012 language requirements are a national issue in which member states determine the appropriate language languages necessary for labels on products in certain industries. However, certain local countries have domestic requirements please consult the chart under the languages section below. Where to find the ce requirements for an user manual. This marking of products is based on compliance with the european harmonized standards and is used to show that products comply with the relevant health and safety requirements many of the ce marking directives impact the requirements for user s instructions. Technical documentation and eu declaration of conformity your. 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. Although many eu directives do not state explicitly that a user manual should be written in the local language or local languages of any given eu member state, in practice this requirement should indeed be met. Current eu law requires albeit based on different legal regulations both the community institutions and the machine manufacturers to produce translations in the languages of the member states. Merchandise labeling requirements at european union level. Heres your brains new user manual for uncertain times. For questions about willmakers documents and interviews, see also willmaker faqs. The ce mark is a legal requirement to place a device on the market in the eu.
Home page of the united states patent and trademark office s main web site. The use of symbols on the label as an alternative to written language is permitted in the mdr regulation. European language labeling for medical devices ce mark. Tech startups should aspire to foster an intuitive relationship with technology and not get distracted by wiz bang promises. This requirement is contained in article 6 2 of the medical devices decree dutch and article 6 of the invitro diagnostic medical devices decree dutch. Member states may require the information, which must be made available to the user and the patient in accordance with annex i, point, to be in their national language s or in another community language, when a device reaches the final user, regardless of whether it is for professional or other use. Countries may further designate required languages and typically designate the language s used by the majority of the population. The user manual is an important part of the ce marking requirements.
Luckily, what needs to be included in the instructions for use for medical devices has been determined in. European language requirements are intended to ensure that each user in each member state will be able to correctly use medical devices which are being imported into europe. The machinery directive ranslation requirements t are stated in annex i, section. Below we provide the language requirements from the toy safety directive. For example, if you are importing a cellphone to luxembourg the user instructions must be written in french and german. Requirements for labelling, instructions for use and language. Global translation requirements for medical devices emergo. Below is a list of each member states general language requirements for labeling. Until the guide changes, manufacturers of machinery have no other choice. One is that everyone talks about ce marking translation requirements without actually reading the specific directives that apply to their products. 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. Article 290 of the ec treaty now article 342 of the treaty on the functioning of the european union and article 190 of the euratom treaty give responsibility to the council, acting unanimously, for determining the rules governing the languages of the community institutions, without prejudice to the provisions contained in the.
You will know which standards to use for creating user instructions. User manual for the eu ecolabel choose your language. Ce marking for medical devices certification experts. Other languages may be added later, depending on user needs. Symbols are efficient, cost saving and internationally understood concepts to convey the required information to the user. This requirement covers all languages in which the label andor ifu are distributed. For machinery and installations user manual requirements are mentioned in the machinery directive 200642ec under annex i, paragraph 1. 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. The medical device regulation eu 2017745 is a set of requirements and processes for you as responsible party. Other member states with two official languages cyprus, malta and ireland accept the sole use of. The declaration is signed by an authorized person of the company, who uses the same language as used in the user manual. Jul 09, 2019 the labelling development process, including producing language translations article 10, 11 the finalised eu declaration of conformity, including versions in the language s of the countries where the device will be distributed. Ce marking translation services language scientific. Determine all eu requirements for user manuals as specified in the applicable, relevant product legislation now that you have an overview of both the mandatory directives and the voluntary harmonised standards, study them in order to find the specific eu requirements on the user manual.
No particular languages are specified by the eu directives although it is mandatory for the ce marking to be translated in the official languages of each specific eu member country. It can be your mother tongue or another language of which you have at least a thorough knowledge level c1 as defined in the european language levels selfassessment grid. Determine the eu requirements for user manuals as specified in the applicable, relevant ce marking product legislation. Countries may further designate required languages and typically. The medical device directive mdd 9342eec, in effect since june 14, 1998, requires non european medical device manufactures to acquire cemarking by complying with. Ce marking for european directives the language center. Ce marking is required for 28 eu member states and the efta european free trade. Emergo analysis of european mdr and ivdr publication. What is ce marking and what are its effects on translation. The language requirement applies to all medical devices comprised by the executive orders regardless of the user s qualifications or profession.
With sharp products in your home or office, you have the assurance of quality and innovation. Breathe easier with our openairways guide to better workouts, less coughing and wheezing, and just maybe a longer life. Inform users on restrictions when using electric or electronic products. 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. Better workouts, less coughing and wheezing, even a longer life. Weve all been thereyou moved to a new home or apartment, and its time to set up electronics and components. Determine the appropriate harmonised standard to instruct users. European translation requirements english to german medical device user manua there is a european standard en 15038. Translations and the eus medical device regulations. European ce marking strategy for medical devices emergo. If you own a ge appliance, its important to have an owners manual to ensure proper maintenance and to answer any questions you may have. With the agreement of individual professional final users, a substance for supply to these final users may be labelled in only one official language or in english. One of the requirements in any eu directive is that a user should. General electric ge appliances offers consumer home appliances.
Apr 03, 2017 countries may further designate required languages and typically designate the language s used by the majority of the population. May 04, 2018 although many eu directives do not state explicitly that a user manual should be written in the local language or local languages of any given eu member state, in practice this requirement should indeed be met. For example, france requires french, belgium requires french, dutch and german, luxembourg requires french, german and luxembourgish, and well, you get the idea. Despite the fact that gaelic was not necessary to do the job in question, the european court of justice in 1987 upheld the requirement of the language qualification in light of the national policy of maintaining and promoting the use of the irish language, and community policy, which did not prohibit such a policy to protect and promote a. The purpose of this user s 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. As a result, the guide may make assumptions about th. Interinstitutional style guide publications office of the eu. The outcome of a correct compliance strategy would require only the product function and precautions for use to be translated to the official language s of the eu state it is to be sold in.
Sharp provides extensive user support to ensure that you know how to use the products you purchase. Product user instructions requirements in the european union. For guidance regarding concerned countrys language requirements. User manual european commission choose your language. When we dont know whats going to happen, we tell ourselves stories about what might happen. 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. Official language in eu required for medical device labeling. These products can cause electrical interference in their direct environment.
It seems like a long way off, but it will be here sooner than we think. In the netherlands, labels and instructions for use must be in dutch. 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 requirement can be dealt with by using symbols. As a notified body under the medical device directives, bsi has the technical expertise and experience to provide ce marking services. Early rate through december 4 technology is part of a modern fascination wi. Language 1 must be one of the 24 official eu languages your main language. Except, when you bought them, you didnt think youd need the user manuals after initially setting them up. Member countries are allowed to specify the language s they require. Mandatory language requirements for medical devices. Urgent or shortlived information appears in a single language initially, given the specific target audience. This year croatia becomes the 28th eu member state to require ce marking. You must translate the eu declaration of conformity into the language or languages required by the.
Determine all eu requirements for user manuals as specified in the applicable, relevant product legislation now that you have an overview of both the mandatory directives and the voluntary harmonised standards, study them in order to find the specific eu requirements on the user manual for your product. The first issue has to do with a typical european challenge. Some manufacturers treat their user information as controlled documentation, so may find it relatively easy to get all these documents organized. All of them have written the mandatory use of their own language for the information on the. Eu professional bodies and language requirements your europe. Mandatory languages requirements for medical devices. An awardwinning team of journalists, designers, and videographers who tell brand stories through f. The personal protective equipment ppe directive annex i, paragraph 1.
While the directives do not specify any particular required languages, they do mandate that ce marking translation be made into the official languages of each particular country. Mandatory language requirements for medical devices depending on the medical devices directive 9342eec mdd the member states of the european economic area, eea, can require their own language. Use this online manual answers basic questions about using quicken willmaker plus. The national language versions of the packaging and instructions available for distributors. Manufacturers are advised to check this with the national authorities concerned. The role of product instructions in product liability. The european unions new medical device regulation mdr will begin being enforced in 2020. These regulations force manufacturers to incorporate language translation and localization into global development strategies as individual member states demand product information in the language of the local user. Eu machinery directive 200642ec translation requirements. Eu translation requirements multi language management.
If the device is an implant listed in schedule 2 of the regulations, the manufacturer is required to include two implant registration cards, as detailed in sections 66 and 67. When your medical device is in accordance with this set of requirements, the cemark can be affixed and the medical device can be legally introduced to the european market. User instructions must be written in language or languages which could be understood by the consumers of the destined market. China medical device labeling requirements language.
The regulation, which represents a sweeping change in the way medical devices are monitored in the eu, was released in 2017 and aims to create more transparency and accessibility in the 100 billion med device market. Possible requirements in eu directives include translations so that users can read the manual in their own language. Regulatory language requirements for medical devices in the eu. A field guide to the main languages of europe publications. You know how to identify the eu requirements for user manuals. How to write a user manual when importing products to the eu. Apr 30, 2015 in europe, the guide to the eu machinery directive specifically requires that a hard copy of the manual accompany machinery. Why the next great technology breakthrough shouldnt need a user manual. How to write instructions for use for medical devices. The ec declaration of conformity must, in some cases, be sent together with the product. For some complex, active or powered devices, the directions for use may require a special surgeons instruction manual, operators manual, and a user s manual. Mandatory language requirements for medical devicesupdatejan. I would like to place the question of language for labeling. Albanian, armenian, azeri, basque, belarusian, bosnian, breton, bulgarian, castilian spanish, catalan.
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