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New EU Task Force Finalizes First Document

 
• By Amanda Maxwell

As news emerges that the Transitional Measures Task Force has issued a Q&A paper, the first document to be issued by this group charged with facilitating the EU regulatory overhaul, Medtech Insight explains the different roles of the TMTF and some other key organizations involved in MDR/IVDR implementation.

The Transitional Measures Task Force, established under the Competent Authorities for Medical Devices groups (CAMD) to help roll out the EU Medical Devices and IVD Regulations, has finalized its first Q&A paper on implementation matters.

While no further details have emerged, the paper, Medtech Insight understands, has been endorsed by the new European Commission's Medical Devices Coordination Group (MDCG) and will soon be published.

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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.

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Industry Execs Talk Tariff Turbulence During MD&M East

 
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More from Geography

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.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel