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The Road to 2024: Regulatory Risks Related to Changed Post-Market Surveillance Requirements and Notified Body Certification

A session by Ronald Boumans
Senior Consultant, Regulatory Affairs, Emergo by UL

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About this session

Most companies are deep into transfer planning to MDR compliance. With three months to go until the date of application, many medical device manufacturers need to ensure their legacy MDD devices are compliant to the relevant aspects of the MDR.

The presentation examines the post-Date of Application period, including - The MDR has more detailed formal PMS requirements. Learn how these separate processes are linked and how this can be made into a comprehensive and consistent system. - The vast majority of manufacturers has planned to transfer certification to the MDR between now and May 2024. Learn about the narrow and bumpy road ahead and what can be done to limit risks.

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