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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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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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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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