1. Medtech Insight

EU Urged To Prioritize Clinical Strategy Talks In Pre-Submission Process

 
• By Amanda Maxwell

EU industry advocates for amendment to existing proposal to streamline clinical strategy costs and timelines, as well as boost efficiency and innovation

EU regulatory efficiency would be improved if companies had a clinical dialogue with notified bodies Shutterstock

Four industry associations have issued a joint paper calling for an amendment to a ready legal instrument that would ease current clinical strategy costs and timelines for companies operating in the medtech space, boosting efficiency and innovation in the EU.

They argue that pre-submission dialogue between notified bodies and manufacturers must include high-level discussions of the proposed clinical strategy.

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