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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. This...

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.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
• By Amanda Maxwell

Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.

Medtech 2025: The Look Ahead For Britain, Switzerland And Germany

 
• By Ashley Yeo

The medtech sector in the UK, Switzerland, and Germany face a challenging 2025, heads of national trade groups say. Competition and access to innovation remain key concerns across the board, with collaboration with the EU and US planned in Switzerland while Germany focuses on approaching elections.

Swiss Move To Prioritize Ambulatory Care In Healthcare Reform

 
• By Ashley Yeo

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

23andMe Purchase Will Let Regeneron Scale Drug Development

 
• By Alaric DeArment

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Disparities — Including Financial Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 
• By Natasha Barrow

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.