New EU regulations (MDR, IVDR)

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 2020 (MDR) or Spring 2022 (IVDR), respectively.

MDR

On 13 March 2019, Brussels issued a corrigendum that you can download here:

On 25 November 2019, Brussels issued a second corrigendum that you can download here:

IVDR

On 13 March 2019, Brussels issued a corrigendum that you can download here:

These regulations replace the existing 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 (in English):
http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/

and on the CAMD (Competent Authorities for Medical Devices) website:
http://www.camd-europe.eu/

Situation in Switzerland

The early revision of the Medical Devices Ordinance (MedDO) was adopted by the Swiss Federal Council on 25 October 2017 and covers all points arising from the new EU regulations that apply as of 26 November 2017.


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.


On this site we will keep you updated about further changes.