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Report on Generating And Assessing Evidence To Optimize MDR And IVDR Due In 2024

 
• By Amanda Maxwell

Recent meeting at Ernst &Young in Brussels outlines steps ahead and likely timelines for gathering information instrumental in shaping recommendations for the future of the MDR/IVDR and their governance structures. 

2023, 2024 and 2025 sprayed onto a road
Report On Optimizing The MDR And MDR Should Be Available A Year From Now • Source: Shutterstock

Both the Medical Device Regulation and the IVD Regulation will be within the scope of a new European Commission-sponsored “Study on Regulatory Governance and Innovation in the field of Medical Devices in the framework of EU for Health.”

This was confirmed at a 21 September meeting at the Brussels offices of Ernst & Young (EY), who have been commissioned to carry out the study. (Also see "Optimizing...

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

 
• By Amanda Maxwell

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

 
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Industry Execs Talk Tariff Turbulence During MD&M East

 
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More from Geography

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.

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.