Current developments in the regulation of direct-to-consumer genetic testing in Europe

Over the past years, direct-to-consumer (DTC) genetic testing has provoked controversy regarding its still questionable risks and benefits. The safety and performance of such devices, when entering the European market, are currently regulated by the Directive 98/79 EC of the European Parliament and of the Council on in vitro diagnostic medical devices. In September 2012, a new Regulation was proposed to replace this Directive, and the...