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Signs Of Hope But Obstacles Remain For Swiss Device MRA With EU

 
• By Ashley Yeo

Without the MRA that allows unimpeded bilateral device trade between the EU and Switzerland, Swiss industry is having to find ways of limiting the damage that newly erected barriers will cause after the MDR comes into force.

Transition sign

“We don’t want special treatment, just that Swiss products are treated the same as those from any other third country to the EU.” So said Swiss Medtech regulatory head Daniel Delfosse, who fears that EU market access will be made much more difficult, if not impossible for some local companies, after the Medical Device Regulation comes into force in the EU on 26 May.

The ongoing failure of two parties to renew the mutual recognition agreement (MRA) to take account of the new medtech...

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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.

Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
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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

 
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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

 
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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

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.