Module 16 2024

24/10/2024

Field Safety Corrective Actions (FSCA) Field Safety Notices (FSN)

Similar requirements to EU MDR Article 87 & 88

(3) The manufacturer must ensure that the PMS system is used throughout the PMS period to identify — (a) preventive actions and corrective actions, including field safety corrective actions;

The manufacture must inform the AB for the device about the FSCA

The AB must review FSCA and determine impact on certification

Proposed FSN to be submitted with FSCA

FSCAs performed outside GB must be submitted where same device is involved but FSCA not planned in GB

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

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AB / NB questions Incidents & FSCA / FSN

Is the assessment and root cause analysis appropriate?

Are the proposed corrective and preventive actions appropriate?

Any new risks or trends identified?

Was the incident / FSCA submitted after investigations have started?

Was the incident / FSCA submitted in required timelines?

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

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