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 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.
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 moreHow 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 Chinaimportal.com, explains what European importers must know about ensuring compliance with various CE marking directives and creating technical files, when buying products from Chinese manufacturers.
Read moreWriting 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
Read more