Module 16 2022

05/09/2022

Notified Body Assessment [2/4]

Must be satisfied that • The clinical data substantiates the benefit-risk ratio and is consistent with EU expectations • Equivalence claims are based upon availability of data from equivalent devices and you have the appropriate access to technical information • The PMS Plan can address key risks or “unknowns” associated to performance, life-time, usability and claims. • The manufacturer continuously updates the clinical evaluation through a robust PMS plan.

The Organisation for Professionals in Regulatory Affairs

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Notified Body Assessment [3/4]

• The NB has access to EUDAMED • Manufacturer shall inform the NB of any vigilance reporting (Contractual Requirement) • NB reviews • Impact of the vigilance data on the CE certificates • Determines if they need to act, monitor, perform extraordinary surveillance measures • Do we have to increase the frequency of surveillance audits

The Organisation for Professionals in Regulatory Affairs

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