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.
EU status
MDR
Regulation (EU) 2017/745 on medical devices
incl. 1st/2nd corrigendum and amendment as regards the dates of application of certain of its provisions of 13 March 2019 / 25 November 2019 / 24 April 2020 (MDR)
IVDR
Regulation (EU) 2017/746 on in-vitro diagnostic medical devices
incl. Corrigendum of 13 March 2019
(IVDR)
(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
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
Modification of the Medical Devices Ordinance (MedDO) 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)