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EU Authorities Call For Thorough Analysis To Avoid Medtech Regulation Review Errors

 
• By Amanda Maxwell

Having already voiced their commitment to working to resolve issues with the implementation of the MDR and IVDR, the national competent authorities for medical devices around the EU are now also calling for a longer-term view.

biz challenge
There Are Many Challenges In Improving Medtech Regulations That Need Addressing • Source: Alamy

The EU’s medtech regulatory authorities recognize there is an urgent need to develop and improve the medtech regulatory system, but say that “doing so reactively and without a thorough analysis and evaluation could lead to significant further disruption and impairment to progress towards an effective EU regulatory system.”

“Taking a wrong turn at this point is not an option,” the Competent Authorities for Medical Devices (CAMD) association adds in a recent statement endorsed by authorities in 20...

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EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

More from Geography

ConcertAI Launches Generative AI-Powered Precision Suite

 
• By Natasha Barrow

Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.