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MedTech Forum 2023: Europe’s Regulatory Maze Must Be Simplified, But How?

 
• By Eliza Slawther

Navigating Europe’s increasingly complex maze of regulations was the topic du jour at this year’s MedTech Forum conference. Despite growing concerns that the EU is losing its historic attractiveness for companies, a spirit of resilience characterized the busy three-day meeting.

Oliver Bisazza, CEO of MedTech Europe, Dublin, 2023
Oliver Bisazza, CEO of MedTech Europe, speaking at the MedTech Forum 2023 in Dublin, Ireland

Hundreds of medtech innovators, policymakers and thought leaders convened in Dublin on 30 May – 1 June for the MedTech Forum 2023, hosted by trade body MedTech Europe, to discuss and debate how best to tackle ever-increasing regulatory pressures faced by EU medical device and diagnostic companies.

Opening the conference, MedTech Europe’s new CEO Oliver Bisazza did not shy away from acknowledging that Europe faces “slowly losing...

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More from Europe

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• By Ashley Yeo

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EU4Health Boost For Orphan Devices And SMEs

 
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Swiss Medtech To Battle ‘Arbitrary’ 39% US Tariff

 
• By Ashley Yeo

In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.

More from Geography

Brazil’s Medtechs Look To Solutions After 50% US Tariff Hit Amid ‘Scenario Of Uncertainty’

 
• By Bernard Murphy

Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.

Survey Reveals Gaps In Medtech Compliance Processes

 
• By Elizabeth Orr

Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.

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• By Brian Bossetta

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.