A mutual recognition agreement (MRA) aligning in vitro diagnostic (IVD) regulations between the European Union and Switzerland has officially expired following the In Vitro Diagnostic Medical Devices Regulation’s (IVDR) May 26, 2022 date of application, impacting certification and authorized representation requirements for manufacturers.
The European Commission has issued new guidelines covering how the expired MRA affects IVD manufacturers now that the IVDR has taken effect in Europe and the Ordinance on In vitro Diagnostic Medical Devices (IvDO) has come into force in Switzerland…
