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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

 
• 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

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 
• By Amanda Maxwell

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

Questions Over UK Prevention Agenda Within NHS 10-Year Plan

 
• By Ashley Yeo

The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.