Additionally, tests for severe illnesses like hiv/aids and cancer, are not allowed to be sold directly to the end user in the Netherlands and some other European countries. Additionally, tests intended for use in the
home envirnment (
home tests, self tests, etc.) have to be assessed by a so-called notified body. This notified body will check the design and information provided by the manufacturer and the instructions, to assess if the test is easy to use and understandable for lay persons.