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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

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More from Geography

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

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Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
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State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
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States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.