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MDD to MDR Transition

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Guest user Created:   Mar 04, 2021 Last commented:   Mar 08, 2021

MDD to MDR Transition

My company recently had an MDD Tech File audit come from our notified body with 4 major and 3 minor nonconformities. Our CE Mark expires April 17, 2021. Can we move to another notified body and work with them on getting our CE Mark under MDR rather than clearing nonconformities with the first notified body. We understand our CE Mark will be under suspension until we comply with MDR.

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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Mar 08, 2021

You can move to another notified body, but most important here is that findings that were raised against MDD are applicable for MDR as well. So you definitively need to solve those findings. Your CE mark will be under suspension until you comply with the MDR.

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Mar 04, 2021

Mar 08, 2021