Why is authorisation as a medical device so important?

If a product is approved as a medical device, this means that it is safe, effective, easy to use and of good quality. This approval shows that the product has been carefully tested and this can be recognised by the CE marking on the product.

This testing concerns not only the manufacture, but also the sale and monitoring of the product on the market. In addition, the safety and efficacy of the product must be proven by scientific studies.