Commentaries: Art. 47e

The Federal Council may:
1. make provision for mandatory notification for the placing on the market of certain medical devices;
2. make provision for mandatory licensing for the placing on the market of certain medical devices, in particular for in vitro diagnostics;
3. make provision for an obligation for economic operators and conformity assessment bodies to use Eudamed or the information system specified in Article 62c .
It shall regulate:
1. the additional obligations of economic operators and health institutions, in particular concerning the registration of the manufacturers and the information to be provided in connection with implantable medical devices;
2. the requirements for the manufacturers’ and authorised representatives’ persons responsible for regulatory compliance, and their other obligations.