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
EUR-Lex - 02017R0745-20240709 - EN EUR-Lex
MDR (europa.eu)
and the
EUR-Lex - 02017R0746-20240709 - EN EUR-Lex
IVDR (In-vitro-Diagnositka) (europa.eu)
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
When the changes entered into force on 1 November 2023, Swissmedic updated its website in this regard and published implementation guides
01.11.2023
01.11.2023
New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022
Entry into force of the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and amendment of the Ordinance on Clinical Trials with Medical Devices (CTO-MedD)
26.05.2022
26.05.2022
New regulations applicable to medical devices as of 26 May 2021
Revision of the Medical Devices Ordinance (MedDO) and the Ordinance on Clinical Trials with Medical Devices (ClinO-MD; SR 810.306) in the context of pending agreements between Switzerland and the EU
26.05.2021
26.05.2021
The FOPH makes the adjustments to Swiss medical device legislation on behalf of the FDHA.
(www.bag.admin.ch)
For information regarding the legislation, please contact the FOPH.
New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022
Entry into force of the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and amendment of the Ordinance on Clinical Trials with Medical Devices (CTO-MedD)