ISO 13485 · Basic · 14 min lesson

Preventive action, advisory notices and recalls - clauses 8.3.3, 8.5.3 and vigilance links

ISO 13485:2016 clauses 8.3.3, 8.5.3, 8.2.3 and 7.5.9, and Regulation (EU) 2017/745 Articles 2, 10, 83, 84, 87, 88 and 89

What you will learn

Explain what clause 8.3.3 requires when nonconforming product is found after delivery, and tell an advisory notice, withdrawal, recall and field safety corrective action apart.
Link the quality system to EU vigilance: reporting clocks in MDR Article 87, trend reporting in Article 88, investigation in Article 89.
Run preventive action under clause 8.5.3, compare weak and compliant records, and answer what the auditor asks.

Key takeaways

Clause 8.3.3 requires proportionate action for product found nonconforming after delivery and a documented, ready procedure for advisory notices.
An advisory notice is a post-delivery communication; recall, withdrawal, FSCA and FSN have distinct meanings in MDR Article 2.
MDR Article 87 clocks run from awareness: 15 days for serious incidents, 10 for death or unanticipated serious deterioration, 2 for a serious public health threat.
Article 89 requires a prompt investigation, no alteration of devices affecting evaluation without informing the authority, and a clear field safety notice.
Clause 8.5.3 removes causes of potential nonconformities, with the same no-adverse-effect check and effectiveness review as corrective action.

Free practice question

Corvane learns on a Friday that set lot 24117, already shipped to nine hospitals, has cracked connectors. The quality manager rings two hospitals, and sales rings others with a different message. No written notice exists and no one is named to decide on a field action.

What does clause 8.3.3 expect?

Phone calls are enough because they are fast.

Not quite. Clause 8.3.3 requires a documented procedure and records of advisory notices, which phone calls alone do not provide.

Action appropriate to the effects, through a documented advisory notice procedure that can be put into effect at any time.

Correct. Clause 8.3.3 requires proportionate action and a ready procedure for advisory notices, with records of the actions taken.

Wait for the authority to instruct the company.

Not quite. Clause 8.3.3 places the duty on the organisation, and regulatory duties in MDR Article 10 require it to act itself.

Rely on the distributor to decide.

Not quite. The organisation holds the duty under clause 8.3.3, and delegating without a procedure leaves no controlled decision.

Key terms

advisory notice: A notice issued by the organisation after delivery to give supplemental information or advise action on use, modification, return or destruction (clause 3.1).
recall: Any measure aimed at achieving the return of a device already made available to the end user (MDR Article 2(62)).
withdrawal: Any measure aimed at preventing a device in the supply chain from being further made available (MDR Article 2(63)).
field safety corrective action: A corrective action by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident (MDR Article 2(68)).
field safety notice: The communication sent by the manufacturer to users about a field safety corrective action (MDR Article 2(69)).
serious incident: An incident that led, might have led or might lead to death, serious deterioration in health or a serious public health threat (MDR Article 2(65)).
preventive action: Action to eliminate the cause of a potential nonconformity before it occurs (clause 8.5.3).
mock recall: A planned exercise that tests whether every consignee of a selected lot can be found and notified quickly.

Official sources

Go further

The full lesson has narrated slides, more scenario questions with explained answers and a simulation.

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Illustrative example. Educational only, not legal advice.