Welcome to The CE Marking Guide, our six-step guide to getting CE marking for your products.
Manufacturers can benefit greatly from the CE marking certification regulations. First, because now the European Union has only one set of requirements and procedures that give access to one of the biggest markets in the world. Also, no formal approval from an authority for market access is required. Moreover, in many cases, mandatory third-party certification can be avoided. Of course, this can help to realize huge cost savings, as well as reduction of the time to market the product.
The manufacturer bears the main responsibility for the conformity of the product with EU CE marking regulations. This makes perfect sense because safety and compliance must be designed into the product. It is the manufacturer that controls a product’s design and manufacturing process. Therefore, it is up to the manufacturer to arrange product compliance with his suppliers and distributors.
In other words, although CE marking regulations in many ways make market access easier, the burden on the shoulders of manufacturers and importers is higher.
According to the CE regulations, the manufacturer and importer are responsible to:
- determine which regulations and requirements apply;
- apply the requirements to the product design;
- assess the product compliance with those requirements;
- ensure the manufacturing process leads to a consistent quality output, so that all units are exactly the same;
- document compliance with technical documentation ('Technical File') and maintaining the files;
- ensure continuous CE compliance when regulations/standards change or the product is modified.
This may seem a straightforward assignment. However, a lot of manufacturers and importers struggle with that.
This is exactly why we developed this guide. You will not only learn about the background of CE marking, but this guide shows you in practical steps what you need to do to get the CE marking for your products.
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This CE Marking Guide applies the ‘Six Step CE Marking Framework’. In the next section, we’ll explain what that framework is, and how you will benefit from it.