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Switzerland: US FDA’s Medtech Can Bridge Innovation Gap Left By MDR

Medtech industry wants more urgency from Swiss authorities to address worsening product shortfall

 
• By Ashley Yeo

Setting the patient safety bar too high will likely have the opposite effect in the case of the EU MDR. So believes the medtech industry in Switzerland, where work has begun at government level to pave the way for Swiss patients to have access to US FDA-approved medtech.

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Switzerland and the EU have begun to experience cases of medtech products no longer being available on their respective markets. The Medical Device Regulation’s more stringent regulatory criteria, its cost to users and persisting lack of structural integrity have compelled some companies to abandon niche and other medtech solutions on the EU market.

In Switzerland, the situation is made worse by the failure of the Federal Council to agree terms that would allow its Institutional Agreement with the EU to be renewed

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