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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.
Read moreWhat 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.
Read moreEuropean 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.
Read moreMeeting 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
Read moreThe intended use
You can read it in almost every manual: a description of the intended use of the product or the machine. It is a description that every technical writer must treat very carefully, because it sets the liability of a manufacturer and affects the further contents of the manual. We will elaborate this in this blog.
Read moreMachinery Directive 2006/42/EC
Every machine that is marketed or used within the European Union must comply with the health and safety requirements from the Machinery Directive. Only if your machine meets these requirements, the machine may be traded within the entire EU. By affixing the CE mark, you declare that your machine complies with the Machinery Directive and possibly other CE guidelines. Next to requirements regarding the design, the Machinery Directive also states demands regarding the documentation. This blog lists the requirements from the Machinery Directive on the manual.
Read moreNew radio equipment directive
The new directive for radio equipment ( 2014/53/EC) repeals R&TTE directive (1999/5/EC). The new directive applies to: “electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination;”
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