Switzerland Models Revisions of Medical Device Law on EU Requirements
The Swiss Federal Office of Public Health issued an update on the alignment of the country’s medical device legislation with the new EU requirements adopted early last year.
Revisions to the country’s Therapeutic Products Act and to the Human Research Act will be followed by a complete overhaul of its Medical Devices Ordinance and a new ordinance for in vitro diagnostics. The adjustments to the Swiss medical devices law will occur in stages, in line with the transitional periods that apply to the EU member states.
The new regulations for medical devices and in vitro diagnostics will introduce stricter requirements, making manufacturers prove the effectiveness of high-risk devices through clinical studies on a more frequent basis.