Legal framework

Since 2001, the regulation of medical devices in Switzerland has been equivalent to that in the EU. The Swiss provisions resulting from the new regulations entered into force on the date of application of, respectively, the

and the

Despite the absence of an update of the medical devices chapter of the Mutual Recognition Agreement (MRA), the equivalence between the Swiss and European medical devices legislation is to be maintained.

Further information can be found on the EU Commission website:

Medical devices are regulated in Switzerland by the following acts and ordinances:

Major revisions of ordinances in Switzerland

The FOPH makes the adjustments to Swiss medical device legislation on behalf of the FDHA.

For information regarding the legislation, please contact the FOPH.