The Medical Devices Introductory Course 2020

Post Market Surveillance

Post Market Surveillance – what is it ?

Generally……. close watch kept over something/monitoring

“…all activities carried out by the manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market, made available or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions” (MDR, Article 2, definition 60)

“A Manufacturers system for gathering data in the post market phase and using it to ensure the continued safety, performance and continual improvement of the product”

The Organisation for Professionals in Regulatory Affairs

Post Market Surveillance

Post Market Surveillance – why do we do it ?

• Protects the Patient and the User

• Ensuring continued safety of the device

Protects the Business

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• Driving product improvement

• Driving regulatory compliance

• Enhancing public profile

• Enhances customer relationship

The Organisation for Professionals in Regulatory Affairs