Importer response should distinguish pre-market blocking from post-market correction. The importer needs a documented escalation path that reaches the manufacturer, product security and legal teams quickly and preserves evidence of the decision and corrective action.
Stop Market Placement Before Sale
Where the importer has reason to believe the product or manufacturer processes are not in conformity with Annex I, Article 19 requires the importer not to place the product on the market until conformity has been restored.
Escalate the Issue to the Manufacturer
The manufacturer is central to correcting product and process non-conformity. The importer should provide the evidence it has and establish whether the issue affects one shipment, one version or a broader product population.
Take Corrective Measures After Market Placement
If the importer learns that a product already placed on the market is non-compliant, it must ensure the necessary corrective measures are taken. This can include bringing the product into conformity, withdrawal or recall depending on the circumstances.
Treat Significant Cybersecurity Risk as an Escalation
Where the product presents a significant cybersecurity risk, the importer must immediately inform the market surveillance authorities of the Member States in which it made the product available and provide details of the non-conformity and corrective measures.
Handle Vulnerability Information Promptly
If the importer becomes aware of a vulnerability, Article 19 requires it to inform the manufacturer without undue delay. The vulnerability may also be evidence of broader non-conformity or significant risk requiring additional action.
Preserve Affected Product and Customer Traceability
Use supply and customer records to identify which product versions and shipments are affected. Effective corrective action depends on knowing where the relevant products went.
Document the Decision Path
Record the issue, evidence, manufacturer communication, risk decision, corrective measures, notifications and closure status. This supports authority cooperation and internal review.
Plan for Manufacturer Cessation
If the manufacturer has ceased operations and cannot comply, Article 19 requires the importer to inform relevant authorities and, by available means and to the extent possible, users of products it placed on the market.
Official sources
Read the full legal text and Commission material for precise wording, qualifications and updates.