Module 16 2022

05/09/2022

PMS Plan

The Organisation for Professionals in Regulatory Affairs

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• Article 84 (MDR) 79 (IVDR) o The legal requirement for a post-market surveillance plan • Section 1.1 of Annex III describes the requirements o Collection and use of available information  Serious includes and FSCA’s  Trend reports  Specialist technical literature, databases or registers o Proactive and systematic process

 So you know how the device is performing and;  You can compare with other devices on market

The Organisation for Professionals in Regulatory Affairs

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