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:

These regulations replace the existing Medical Device Directives:

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

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.

Further information can be found on the EU Commission website (in English):

and on the CAMD (Competent Authorities for Medical Devices) website:

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.
Medizinprodukteverordnung, Stand 26. November 2017
(The English translation of the new version of the MedDO of October 25th, 2017 is not yet available.)

The FOPH has published a statement on the planned revision of the Medical Devices Ordinance (MedDO) and other Swiss laws:

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

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

Last modification 23.11.2017

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