Overcoming New EU MDR & IVDR Regulation Challenges

Presented by

Karen Hill, Sr. Manager, Reg Affairs, Medical Devices, ICON

About this talk

The new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) represent some of the most wide-ranging and disruptive changes to recently affect the world’s second-largest medical technology market. Now, with just a two- to four-year transition period before full compliance is required in 2020 for MDR and 2022 for IVDR, device developers will need to implement changes to help new and existing products succeed. This webinar discusses: - The key changes that are occurring under the new regulations - How to prioritize your product portfolio - The importance of early planning in preparing clinical studies to certify new devices and to recertify existing ones - How early transition can give your products an advantage in the market

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BioPharma companies and Medical Devices manufacturers face growing operational, regulatory and economic challenges when it comes to developing their drug or device. ICON provides analysis and key insights on these challenges, with practical advice and recommendations.