Module 16 2024

10/17/2024

MDR Extended Transition Timeline

TOPICS

Source: Modified infographic from European Commission Presentation on IMDRFMeeting 09SEP24

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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Why was an extension timeline needed?

The resources of qualified NBs in 2022 was not sufficient to transfer all existing medical device certificates into the MDR during the initial transition timeline.

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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