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(UPDATE) EU Standards: Potential Hiatus As Priorities, Deadlines And Timeframes Take Shape

 
• By Amanda Maxwell

The European Commission’s long overdue MDR/IVDR standards request document – still a draft – gives the European standards bodies just over a week from today to respond. But CEN/Cenelec says it cannot reply yet. So what is the problem?

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The European Commission has, at last, set out the terms of its request for standards to assist manufacturers comply with the new EU Medical Device and IVD Regulations to the European standards bodies, CEN and Cenelec.

The terms of the request are set out in a draft Commission Implementing Decision.The document says that the next step is for the standards committees to respond to the...

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• 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.

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• By Natasha Barrow

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

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More from Geography

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

ConcertAI Launches Generative AI-Powered Precision Suite

 
• By Natasha Barrow

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