Legal Background: The Clinical Trials Directive (2001/20/EC) requires that for all clinical drug trials in the EU a sponsor or a legal representative of the sponsor must be legally registered within the European Economic Area. The various member states have implemented this Directive into regulations that apply within each territory separately.
National legislation of some EU member states demands that for clinical investigations with medical devices there must either be a sponsor in the EU or the sponsor must assign an EU representative.
Legal Background: On January 1st, 2014, a completely revised legislation for clinical trials has become valid in Switzerland. According to Article 2 (c) of the “Ordinance on clinical trials with therapeutic products” a sponsor not established in Switzerland has to assign a representative based in Switzerland. This change applies to all clinical trials with medicinal products (i.e. drugs), with medical devices, or any other intervention.
The official explanation document to the “Ordinance on clinical trials with therapeutic products” asks for the representative of the sponsor for a clinical trial to fulfill the duties of the sponsor. In addition the “Ordinance on human research with the exception of clinical trials” requests for cases in which the sponsor (and not the investigator) is responsible for the organization of the human research projects which are not clinical trials, for the sponsor to be established in Switzerland or to nominate a Swiss representative.