Last July 2020 the Swiss Federal Council approved the revision of the Medical Devices Ordinance (MedDO), along with the new Ordinance on Clinical Trials for Medical Devices (ClinO-MD). Both ordinances will take effect on May 26, 2021 to align with the EU Medical Devices Regulation MDR (EU) 2017/745 application date.
As the equivalence of the relevant legal requirements is a prerequisite for the mutual recognition agreement (MRA) between Switzerland and the EU, the Swiss Federal Council intends to align the MedDO to adapt it to the MDR (EU) 2017/745 and to safeguard harmonization of regulatory system with the rest of Europe.
The Swiss regulation on Medical Devices is therefore being amended. It is also expected that the provisions relating to in vitro diagnostic Medical Devices will be included in a separate regulation that will be harmonized with the In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746.
The application date of the IVDR (EU) 2017/746 is set for May 26, 2022, while the consultation on implementing legislation is scheduled for summer 2021.
Discover what we can do for you!
Thema offers strategic – regulatory consulting services for companies operating in the field of Medical Devices and IVD.
Contact us to know all the details and if you want to stay up to date Thema activities, subscribe to our newsletter!
Source:
