Medtech Insight

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

11 Jun 2024

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...