Switzerland has concluded treaties with EU Member States, EFTA States and Turkey with regard to the mutual recognition of conformity assessments for medical devices (bilateral agreements or mutual recognition agreements - MRAs). The basis for these treaties consists of the application of the European guidelines on medical devices and the European CE mark. The States concerned recognise the certificates issued by the Swiss conformity assessment bodies, and in return, Switzerland recognises conformity assessments carried out by Notified Bodies / Conformity Assessment Bodies in the States in question.
The treaties simplify the mandatory reporting requirements for placing devices on the market, and permit direct distribution from Switzerland to all EU and EFTA Member States and Turkey, without an authorised representative with registered offices in the said countries. In return, companies with registered offices in the countries concerned can distribute compliant medical devices directly to Switzerland.
