In a move towards harmonisation with the EU Medical Device Regulation (MDR), the Swiss Federal Council have approved a thorough revision of MedDO and the new Ordinance on clinical Trials for Medical Devices (ClinO-MD).
Both revisions will take effect on May 26, 2021, in order to align with the MDR application date. As the equivalence of relevant legal requirements is a prerequisite for the Mutual Recognition Agreement (MRA) between Switzerland and the EU, the Swiss Federal Council intends to revise MedDO to match MDR and safeguard Switzerland’s continuing market participation.
On August 1, 2020, an amendment to MedDO will also become effective. The amendment establishes derogation procedures or exemptions for medical devices that did not undergo a conformity assessment procedure under certain circumstances.
Yet to be approved is the harmonisation of the regulations surrounding in-vitro diagnostic devices with the EU In-Vitro Diagnostics Medical Device Regulation (IVDR).
For the latest status on the Swiss medical device legislation, click here.