1. Medtech Insight
  2. >>Geography
  3. >>Europe

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 
• By Natasha Barrow

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Investors Urged To Prioritize Patient Engagement To Ensure Clients’ Products Succeed

 
• By Amanda Maxwell

To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 
• By Amanda Maxwell

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

More from Geography

Questions Over UK Prevention Agenda Within NHS 10-Year Plan

 
• By Ashley Yeo

The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.

Former Top OIG Attorney Gives Inside Look At Fraud Prevention

 
• By Elizabeth Orr

Former HHS-OIG attorney Rob DeConti emphasized the significance of data analytics and compliance in combating healthcare fraud, urging medical tech companies to adopt robust measures to prevent potential risks.

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 
• By Brian Bossetta

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.