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Extensive EU Medtech Regulatory Survey Reveals Scale Of MDR Hurdles And Where Problems Lie

 
• By Amanda Maxwell

MedTech Europe says solutions are still urgently needed to ensure the MDR is on course and warns that 50% of companies are deprioritizing the EU as launch market, potentially denying EU citizens vital health care.

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There is still a long and difficult MDR compliance journey ahead

Medical Device Regulation certificates have not been issued yet for over 85% of the more than 500,000 devices previously certified under the Medical Devices Directive or the Active Implantable Medical Devices Directive. Only 69,239 devices have been certified to the MDR in the past three years.

That is the shocking figure just released by MedTech Europe, the EU’s largest medtech industry association, in a survey...

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More from Europe

EU4Health Boost For Orphan Devices And SMEs

 
• By Ashley Yeo

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

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.

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By Marion Webb

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.

US Puts 15% Tariff On EU Exports But Medtechs Push ‘Zero For Zero’

 
• By Ashley Yeo

The US’ foreign trading partners are not working hard enough to secure bilateral deals, says US President Donald Trump, who will introduce new reciprocal tariffs on Aug. 7. MedTech Europe stresses that patients will suffer if medtech is not excluded from the tariffs.

More from Geography

EU4Health Boost For Orphan Devices And SMEs

 
• By Ashley Yeo

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

FTC Blocks Edwards Lifesciences’ Merger With JenaValve

 
• By Elizabeth Orr

The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.

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.