WHAT CAN WE DO FOR YOU ?

The situation

According to our experience most cosmetic devices we have seen in the EEC market does not have a legal CE. As the manufacturer, importer, seller or user of the devices is exposed to high financial risks. The damages to the image and the black listing of the company with the TÜV web side and other public accessible web sites only as one of the mild consequences. The other consequences, such as an imposed sale and import prohibition, anti-trust warnings or purchase price reimbursement, are considered to be as much more unpleasant.

There is a high uncertainty among the users of the devices, the importers who mostly import the devices from the Far East, and also among the manufacturers as to what exactly is required to launch the device properly in the market. Even the companies that want to act responsibly and make an effort for a proper placement in the market, frequently make mistakes that can have grave consequences. Often, the market players turn to institutions and test institutes that are not at all authorized to issue certificates or conduct the prescribed tests.

Unfortunately, the market players are simply not aware of the risks. Even for the experts it is not easy to have an overview of the laws, rules, regulations and standards.

Along with an image demage of the company, the managing director of a company is at times affected personally in case of negligence and is fully accountable with his private assets. Most of the importers especially rely on the fact that the documents they have received from the manufacturers (mostly from the Far East) are completely in order. However, this is playing with fire. In most of the cases, the manufacturers lack the necessary knowledge of how to make the devices marketable for the European market. Many manufacturers also balk at the high costs, which an EU conformity process conforming to the standards would entail. Added to this is often a lack of interest, because the number of pieces delivered in many countries is very low to make a full-fledged approval worthwhile. In addition, the long arm of the law reaches only till the external borders of the EU. Manufacturers in the Far East know this and handle the regulations applicable here in a rather easy-going way.

It is always the seller or the importer who is responsible and within reach of the authorities. They are treated legally as a manufacturer. The manufacturers are aware of this too and thus, based on experience, the motivation to take up the effort and the costs for a really proper launch in the market is not very high.

Till now, this went very well for many market players, since the authorities were not able to do a comprehensive check. However, the sensitivity of the authorities as well as their know-how has increased. It can be assumed that in the future many more devices will be checked and withdrawn from the market.