Articles about
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.
Read moreProduct 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.
Read moreCE-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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