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EU Regulatory Roundup, September 2023: Dismantling Regulatory Barriers To Medtech Innovation

 
• By Amanda Maxwell

The call for more to be done about the EU’s regulatory hurdles to innovation, as well as for improvements to governance, has now grown to a crescendo. While the EU looks at how best to move forward, innovation in the UK is benefiting from greater regulatory freedoms.

Top Stories EU

During the month of September, there were high-level calls for support for innovation in the EU, in the form of a white paper from Germany industry associations, an open letter from a total of 35 associations in the EU and discussions at the International Medical Device Regulators Forum, held in Berlin late in the month.

For several years now, there have been an increasing number of reports of manufacturers choosing to launch their new products in the US or other mature markets, instead of the...

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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.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

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Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

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MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

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More from Geography

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

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Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

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• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.