The Medical Devices Introductory Course 2020

FSCA

2017/745 Article 83,

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section 3 “ Data gathered by the manufacturer’s post market surveillance system shall in particular be used: (e) for the identification of needs for preventive , corrective or field safety corrective action ” section 4 “If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87”

The Organisation for Professionals in Regulatory Affairs

FSCA

The Decision

• When should a manufacturer conduct an FSCA ?

• What are the criteria that should be considered ? – The nature of the problem – Frequency of occurrence of a problem – Severity and probability of harm associated with the problem (Day 2, 10,15 report)

(Often referred to as an HHE (Health Hazard Evaluation))

• Who should have final say in this decision?

The Organisation for Professionals in Regulatory Affairs

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