European legislation of biomedical technology.

The primary objectives which the European directive proposal wants to reach are: a) to guarantee a high quality standard of the products which are put into the EC market, for the user; b) to guarantee the safety and health of the user and of all other people who come into direct contact with the said products. The directives define a precise scheme of regulation and control for all medical devices and this scheme is in force for all the member states of European Union.