Exploring the Impact of IVDR and MDR -2024 Survey Findings

About this episode

The episode discusses the findings of the 2024 Regulatory Survey regarding IVDR and MDR challenges faced by manufacturers.

Welcome to the 6th Season of the MedTech ON AIR podcast. ​ This 2025 season kicks off with an episode dedicated to the 2024 Regulatory Survey findings​ The 2024 Regulatory Survey revealed key challenges that manufacturers face under the In Vitro Diagnostic Regulation (IVDR) and Medical Device Regulation (MDR) – from conformity assessment timelines, to the costs of compliance, to the impact on research and innovation, the report highlights important trends ​ Listen in as Petra Zoellner, Director IVDR and MDR, dive deeper into the findings, and discusses what they mean for manufacturers still navigating the transition, and what policymakers and all stakeholders can do to improve regulatory predictability. ​ Find the regulatory survey here: https://www.medtecheurope.org/resource-library/medtech-europe-2024-regulatory-survey-key-findings-and-insights/

People in this episode

Guest: Petra Zoellner

Topics covered

• IVDR
• MDR
• regulatory challenges
• manufacturers
• compliance costs
• research and innovation
• regulatory predictability

Keywords

• IVDR
• MDR
• regulatory survey
• manufacturers
• compliance
• research
• innovation
• regulatory predictability

Mentioned in this episode

Organizations: MedTech Europe

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