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Urgent Action Needed To Address Deficiencies In EU's IVD Regulation – As Well As MDR

 
• By Amanda Maxwell

So far, calls for much needed changes to the medtech regulatory system have focused on the Medical Device Regulation. Don’t neglect the IVD Regulation, industry says.

Status quo versus change
• Source: Alamy

The European medical technology industry is calling on the incoming European Health Commissioner, Olivér Várhelyi, to prioritize the regulation of diagnostic technologies as a crucial component of the overall healthcare system and not just to focus on the regulation of medical devices that come up the scope of the Medical Device Regulation (MDR).

In a joint statement responding to the priorities for medtech regulation outlined in the mission letter from Ursula von...

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European MedTech Keeps Calm Despite US Threats Of 30% Tariffs

 
• By Amanda Maxwell

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Burden Is Too Heavy For Medtechs To Go It Alone On Complex Medtech AI Projects

 
• By Amanda Maxwell

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More from Geography

Ochsner Surgeon In ‘The Big Easy’ Eases Patient’s Pain With Skill And Virtual Reality

 
• By Brian Bossetta

A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By Elizabeth Orr

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 
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Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.