Module 16 2022

05/09/2022

Situation • Manufacturer’s plan lacks sufficient proactive post market activities which are mandatory. Not having an appropriate PMS plan or not executing an approved plan

Implication • If a NB issues a CE certificate based on an established PMS Plan, but if at the time of renewal that plan has not been executed, this can be a serious problem

The Organisation for Professionals in Regulatory Affairs

25

Any Questions

The Organisation for Professionals in Regulatory Affairs

26