Module 16 2024

21/10/2024

Items for consideration

• What additional information is needed before a decision can be taken?

• Should the incident be reported to a Competent Authority?

• Which Competent Authority should be notified?

• Should a Vigilance Incident report be made and indicate whether it leads to :- Field Safety Corrective action (FSCA) notified via a Field safety Notice (FSN)? • What is the timescale for the report? (also refer to MDR Art 87)

• What reference to regulation or guidance should be made?

• If not reportable, what other actions may be required?

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Advice

• Think broadly and critically

• Don’t make assumptions – ask questions

• Support each conclusion/decision by referencing the regulation or guidance

• Discuss issues raised by each scenario

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