EU IVDR v. CH IvDO: How are In Vitro Diagnostic Medical Devices regulated on the Swiss market?

The end of the Mutual Recognition Agreement

On May 26, 2022, the new Regulation 2017/746 (IVDR) repealed Directive 98/79/EC on in-vitro diagnostic devices (IVDD), which was part of the Mutual Recognition Agreement between the EU and Switzerland. Due to the absence of a renewal of the MRA, Switzerland lost its special status and became a “third country”. This meant that a separate regulatory . . .


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