Medical Devices Post-Market Surveillance: Compliance in the European Union and Major International Markets
This white paper provides an overview of the basic concepts and requirements of the Post-Market Surveillance System (PMS) in the European Union and major international markets. The aim is to impart the essential theoretical tools to deploy an effective post-market surveillance strategy in full compliance with regulatory compliance.
1.INTRODUCTION
Post-market surveillance (PMS) plays a key role in the life cycle of medical devices, as it is essential to ensure their safety and efficacy after marketing. This integrated system involves not only manufacturers but also all the economic operators that make up the supply chain – importers, distributors, agents, and external suppliers – and extends to all devices on national and international markets. […]
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