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  • CE marking

    The European “New Approach” Directives are the basis for CE (Conformité Européenne) 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. In order to ensure that your product is able to be widely distributed within the EU, it’s important to know what the European New Approach Directives mean, and exactly how they will impact you and the manuals of the products that you offer.

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  • CE-marking medical software

    Medical devices, such as infusion pumps and MRI scanners, need to be certified according to European CE rules. For a manufacturer, however, it is not always clear whether his product needs a ‘medical’ CE certification. This is especially true for any embedded software.

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  • What are mandatory instructions?

    Do mandatory instructions exist, whether these would be mandatory online instructions, mandatory operating instructions or any other kind of working instructions? Actually, they do not. There is nothing ‘mandatory’ about instructions. The term ‘mandatory instruction’ has its merits though. One could interpret mandatory instructions as instructions that should meet certain criteria.

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  • How to Create a Technical File When Importing from China

    Ensuring compliance with EU regulations, including the creation of a technical file, is complicated enough as it is. Throw a supplier on the other side of the plan, that may not even know what a ‘Declaration of Conformity’’ is, and you have a real problem to deal with. In this article, Fredrik Gronkvist, ​co-founder of​, explains what European importers must know about ensuring compliance with various CE marking directives and creating technical files, when buying products from Chinese manufacturers.

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  • European directives and… manuals

    Almost all countries in Europe are member of the European Union, or are somehow affiliated to the EU. This has important consequences for setting up any manual. In the EU, the European directives on the safe use of a product also have something to say on the requirements for the accompanying manual. As such, a company can be held accountable if a manual is not in compliance with the relevant European directive.

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  • Meeting legal requirements = a manual without a worry

    Are you planning to sell your product or set of products abroad? Then you should be aware of the legal requirements that not only apply to your product(s), but also to your manual(s). We can check if your manual meets all necessary legal requirements, wherever on the globe, including, of course, the question if translation is required

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  • Writing terms of warranty

    A manufacturer or reseller has to repair or replace a product that is faulty. Also, a buyer could ask for a (partial) refund if it is clear that he used the product correctly right from the start. In Europe, the warranty for a product should be valid for at least two years. Your terms of warranty could extend that period for any given tim

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  • Language manual

    It is one of the most popular questions for any worldwide operating technical writer: does the English language suffice for our manuals in our international world? After all, English is the lingua franca wherever you are on our globe. Why, then, should one publish a manual in the language of the local user? The answer to this question can be straightforward: the English language does not fit the bill in other than English speaking countries. The reason? Your own mother tongue is easier to understand.

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  • Product safety and instructions in the EU and US

    In the European Union 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. Many of these CE marking directives also set requirements for user’s instructions. Although there are many similarities, the process of product compliance in the US is slightly different from the process of EU compliance.

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  • NEN 5509

    As part of Manualise, over the past few years I have participated in the standards committee for revision of NEN5509 – User Manuals. The new draft of the standard was recently published. For more info see this press release.You can view the draft via this link. You can comment on it until 15 October via this link. After this time the committee will schedule a meeting to discuss all the comments.

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