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Swiss Medtechs Contrast EU MDR ‘Chaos’ With Picture Of US Regulatory Efficiency

The EU is dropping down the list of launch markets for medtech innovation

 
• By Ashley Yeo

The ongoing failure of Swiss and European Commission decision makers to resolve the issue of Switzerland’s institutional agreement is hampering EU market access for Swiss innovators like IVDs company Abionic. More pressingly, the EU must address the wider issue of the MDR’s negative impact on innovation and start-ups, says Abionic co-founder Iwan Märki.

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Swiss medtech innovators find themselves between two stools – one in Brussels and the other in Berne. Politicians on both sides are unable or unwilling to resolve the thorny issue of Switzerland’s institutional agreement with the EU, and for the medtech industry, the EU-Swiss mutual recognition agreement (MRA).

Lausanne-based Abionic SA has a pancreatic stone protein (PSP) test on its abioSCOPE platform to detect sepsis in the ICU

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