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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...

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More from Switzerland

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

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Swiss Move To Prioritize Ambulatory Care In Healthcare Reform

 
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Medtechs will be indirectly affected by a new law in Switzerland that unifies the amount of funding allocated to inpatient and ambulatory care.

More from Europe

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
• By Amanda Maxwell

Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

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The Modern Industrial Strategy is the first of this summer’s UK blueprints for supporting life sciences industrial activity and transforming NHS healthcare delivery. The UK market must also benefit from its own innovation activity, says industry.