New medical devices regulations

EU status

On 5 April 2017, the two new EU Regulations on medical devices were adopted by the European Parliament. The new Regulations entered into force on 26 May 2017 and shall apply after graduated transitional periods, ranging from 6 months to 5 years, in spring 2021 (MDR) and spring 2022 (IVDR) respectively.

MDR
IVDR

These regulations replace the following Medical Device Directives:

  • Directive on active implantable medical devices (New Window) 90/385/EEC (AIMD)
  • Directive concerning medical devices (New Window) 93/42/EEC (MDD)
  • Directive on in-vitro diagnostic medical devices (New Window) 98/79/EEC (IVDD)

Further information can be found on the EU Commission website:

Situation in Switzerland





The Federal Office of Public Health (FOPH) is responsible for revising the Swiss legislation. Further information on this can be found on the FOPH website.

Please contact the FOPH if you have any questions about the revised law.