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swissdamed Database Needs A Few More Months With UDI Model Now Underway

Swiss modular database taking shape now using Swissmedic Cloud

 
• By Ashley Yeo

Switzerland has been developing a national medical devices database to mirror Eudamed, the EU version that has excluded participation by Swiss companies since the failure of the federal council and European Commission to update the MRA for devices.

By Maxim Gaigul Royalty-free stock illustration ID: 476308105 Computer keyboard, close-up button of the flag of Switzerland. 3D render of a laptop keyboard

Qualitative improvements have been made to swissdamed, the IT system to support application of the Swiss regulations on medical devices and in vitro diagnostic medical devices, leading to go-live dates being deferred by a few months.

Swissdamed − the Swiss Database on Medical Devices – will enable the regulator, Swissmedic, to directly register economic operators using...

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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

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

 
• By Ashley Yeo

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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

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
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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.