They can be found on every product: quality marks! CE, UL, CSA and so on. What is a quality mark for and what do you have to deal with if you design a product yourself and want to market it? In this article we will discuss 5 misunderstandings about a quality mark.
A quality mark is actually only about one thing: safety. The world must, of course, be protected against faulty and unsafe products. You don't want to get a shock from an electrical device, a child should not choke on a detached eye from a cuddly toy and your toaster should not cause a fire. It is logical that the legislator imposes rules on this and creates clarity about responsibilities. This is guaranteed through the rules surrounding a quality mark.
The European Commission has determined that Member States must ensure that only products with a CE mark be placed on the market. So it is mandatory! There are some exceptions, but even then there are still rules. However, it also pays off: the marketing of products with a CE mark may not be refused. The Netherlands also has a duty to monitor and, where necessary, impose sanctions to prevent unsafe products from entering the market. Outside the European Union, other quality marks apply and these are also often mandatory. In this article, however, we now focus on the CE mark.
The European Commission has drawn up guidelines for a number of types of equipment. A few examples are: toys, low voltage, elevators and medical equipment. A full list can be viewed at this site † These guidelines are free to download. Please note: The device to be marketed can fall into a number of categories, for example low voltage and medical.
The first step in the process towards a CE mark is to see which guidelines the device falls within. Subsequently, each directive has its own essential requirements. In order to meet these essential requirements, it is highly recommended to use the standards agreed within the Member States (these can be found behind each directive on the said site, for toys these are for example these harmonized standards † This makes it a lot easier to demonstrate that your product complies.
The essential requirements always play a decisive role, not the standards, but these are very useful to be able to demonstrate that you comply!
This is by definition incorrect. The manufacturer of the component knows nothing about the ultimate application and the CE mark on the component will therefore most likely not have been tested against the correct essential requirements.
A computer with a CE mark will, among other things, be tested for the low voltage directive. If the same computer is built into a medical device, a different directive becomes active and also other essential requirements that must be met.
In short: CE + CE CE!
The producer is responsible and the producer is defined as: the person who is responsible for the design and production of a product for the purpose of yourself on the (European) market. The quality mark is therefore primarily concerned with the responsibility for 'marketing'.
Furthermore, the guideline states that the producer may use a finished product and/or components and may also outsource design or production tasks, so 'producer' is more concerned with bringing the product to the market than with the actual production.
The producer is therefore ultimately responsible for the product and must ensure that the product is CE compliant. So there is no need to delegate responsibility! If you still want this, the person who then becomes the producer will have to become the owner of the product. If you want to sell it pure, you have to agree in a contract with him that you are the (only) distributor. However, the name of the actual producer is always stated on the product and/or packaging.
This is incorrect. You declare that your product is CE compliant. For products within certain guidelines it is necessary that an external party (in CE terms, referred to as a notified body) carries out checks on this, but for a large part you can do this yourself. After all, you are also responsible!
Obtaining a CE worthy device starts with a safe design and this must also be properly reproduced. To check whether a product is safe, it is therefore necessary to look at the design process and the manufacturing process† To demonstrate that the design complies, you will often have to have inspections carried out that you cannot do yourself (not the right equipment and/or knowledge). It is useful to involve external parties for these inspections.
To demonstrate that you continue to produce the products in accordance with the first approved design, it is recommended that you have a quality system in place. However, this is also not mandatory.
Finally, an important tip: Do not let the CE mark scare you off and start early. By paying attention to the mark at an early stage and making the right choices in the design, you avoid many unnecessary costs and delays.
