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Oliver Bisazza Warns That EU’s Innovation Issues May Create More Reliance On Medtech Imports

But There Is Still Plenty Of Research Potential In The EU

 
• By Amanda Maxwell

Innovation has been hindered in the EU by the costs and complexities of compliance, including in the medtech sector. Bisazza looks at how high-level, multi-sectoral moves are underway to create a more innovation-friendly environment.

Idea breakthrough and the power to demolish an obstacle with creative thinking and innovative solutions as a light bulb shaped as a wrecking ball with 3D illustration elements.
Tough Challenges In EU For Launching Innovative Products Need Tough Solutions

While the EU should preserve the regulations’ high bars of safety and performance, it should make costs more proportionate, and procedures more efficient and predictable. But we are not there yet. That is what Oliver Bisazza, CEO of MedTech Europe, told Medtech Insight in an interview held during the first day of the MedTech Forum in Vienna on 23 May.

The costs of compliance with the IVDR and MDR are not only higher than the FDA’s premarket approval procedure, which used to globally be the most expensive, but even more...

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Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.