Module 18 2021

05/02/2021

Article 117 – Impact on Pharmaceutical Companies

• Need to find & work with a MDR designated Notified Body • This is a big concern – A new stakeholder, availabilities and timelines • Obtain Notified Body assessment report • Include this assessment report in the MAA • Applies to all new MAAs after 26th May 2021 • In case of changes to device, Notified Body reassessment required for significant change to the device

The Organisation for Professionals in Regulatory Affairs

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Notified Body Assessment: Article 117

The Organisation for Professionals in Regulatory Affairs

32

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