News about GMP/cGMP

17.07.2020

Switzerland: New MepV and KlinV-Mep adopted

On 1 July 2020, the Swiss Federal Council adopted the revised Ordinance on Medical Devices (MedDO) and the new Ordinance on Clinical Trials for Medical Devices (ClinO-MD).   

These set out the executive measures of the Swiss Therapeutic Products Act and the Swiss Human Research Act approved in 2019. Since 2001, these laws have been based on the provisions of the European Union.  
As the European Medical Devices Regulation (MDR) will now only come into force on 26 May 2021 due to the COVID-19 pandemic, Switzerland is adapting its legislation gradually. Only the regulations deviating therefrom concerning the placing on the market and commissioning of medical devices that have not been subject to a conformity assessment procedure will come into force on 1 August 2020.  
The requirements of the European Regulation on In Vitro Diagnostic Medical Devices (IVDR), which comes into force on 26 May 2022, will be incorporated into a separate regulation. This will be assessed in summer 2021.  
In addition to these projects, the agreement between Switzerland and the EU on the mutual recognition of conformity assessments (MRA) will also be updated. 


Quelle:

Swissmedic: Federal Council approves new MedDO and ClinO-MD 



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