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Taking Steps Towards Improving Innovation Opportunities In The EU Regulatory Environment

 
• By Amanda Maxwell

The German notified body, TÜV SÜD, is looking to help create a more favorable regulatory environment for medtech innovation within the EU as the debate continues over damaging MDR/IVDR implementation practices.  

original innovation
Making the EU More Favorable For Innovation • Source: Shutterstock

TÜV SÜD Denmark is a new candidate EU notified body in Denmark in the later stages of the designation process whose structure and processes are based on an “innovation mindset.” In other words, one of its priorities will be to support clients with innovative products as they manage the specific challenges for their devices related to compliance with the Medical Device Regulation.

The notified body’s procedures are tailored, from scratch, towards MDR requirements rather than based on modifying previous processes, Sabina Hoekstra-van den Bosch, global director regulatory strategy at the notified body...

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