IVD: What is the status of the Mutual Recognition Agreement between the EU and Switzerland?

From May 26, 2022, the agreement between Switzerland and the European Union on mutual recognition for the market of in vitro diagnostic medical devices will no longer apply. Until that date, Swiss manufacturers could place IVD medical devices on the European Union thanks to the Mutual Recognition Agreement (MRA) without any additional regulatory requirements. However, this will change in two days with the IVDR becoming applicable on the EU market. Contrary to the Directive, which the Regulation will replace on May 26, 2022, the MRA will no longer cover IVDs.
What does this mean for manufacturer?

 

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