Advisiory Notice [ISO 13485 Clause 8.3.3]
This clause requires that organisations establish documented procedures for the issue and implementation of advisory notices, which include notices such as product recalls, safety alerts, or field safety notices. EN ISO 13485:XXXX is critically important in the EU because it directly supports compliance with the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
ISO 13485 Clause 8.3.3 for advisory notice ensures that manufacturers have a system in place to issue Field Safety Corrective Actions (FSCAs) such as Field Safety Notices (FSNs), which is mandatory under MDR Article 87 & 89. In the EU, failure to notify relevant stakeholders can lead to legal action, reputational damage, or withdrawal of CE certification.
Frequently Asked Questions
What are the key requirements in clause 8.3.3
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Documented Procedure: You must have a documented process for preparing, approving, and issuing advisory notices.
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Regulatory Compliance: The advisory notice procedure must meet regulatory requirements of the countries where the product is made available.
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Implementation Control: Procedures must include how advisory notices are implemented and tracked.
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Post-Advisory Actions: Any advisory notice must be followed by appropriate corrective actions as per Clause 8.5.2 and 8.5.3.
What are the related clauses of Advisory Notice
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Clause 8.2.1: Feedback system that may lead to an advisory notice.
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Clause 8.2.2: Complaint handling, which may trigger an advisory notice.
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Clause 8.3.1 – 8.3.4: Control of nonconforming product (advisory notice may relate to nonconformance).
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Clause 8.5.2: Corrective action.
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Clause 8.5.3: Preventive action.