Module 16 2022

05/09/2022

Notified Body Assessment [4/4]

• Confirms the Manufacturer has appropriate processes in place to collect data (QMS Audits) • Evaluates the implementation of the procedures to consistently gather necessary data and take appropriate action • Checks that the Manufacturer is meeting their legal obligations – Are they doing what they say they would? • Verifies Manufacturers conclusions are based on scientific data and appropriate evidence to support claims made • Constantly review the Risk: Benefit profile of the device is satisfactory

The Organisation for Professionals in Regulatory Affairs

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NB Role in PMS

• Ensure PMS procedures are device specific and include a requirement to update the clinical evaluation with post market data • Ensure that PMS procedures that contain both reactive and proactive elements • Ensures that the review of post-production information feeds back into the risk management for the device (per ISO 14971).

The Organisation for Professionals in Regulatory Affairs

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