NC Incomplete PSUR, Easy Peasy

NC – Incomplete PSUR

An annual Periodic Safety Update Report is required for both Medical Devices (except Class I) and In Vitro Diagnostic Medical Devices.  The inputs to the PSUR are usually viewed as data inputs which is the root cause of an incomplete PSUR.

Quality subsystems and processes such as CAPA, Clinical evaluation, risk management, Vigilance, and Field Actions are required to be linked and ordered in accordance with a closed loop post market surveillance system to sustain compliance over time.

Sustaining Compliance vs Initial Compliance

One subtle requirement that is easy to address is to document in the Post Market Surveillance Plan that the Previous year’s PSUR is an input to the current PSUR.

The subsequent difficulty is maintaining alignment and managing the narrative regarding incomplete CAPA that were not addressed (from previous PSUR) and issues brought forward during the initial release of the PSUR.

This example highlights the relational impact of information over time.  The example also shows the complexity of changes through the post market surveillance system as new field information and feedback are continuously provided (as products are used).

Why Reinvent the Wheel?

The example in the attached video demonstrates the value of QMS Velocity as both a guide and solution to become compliant to EU MDR and IVDR requirements and how to sustain compliance over time.  The editable and formatted solutions are plug and play ready for easy adoption into a medical device QMS.