EU Market Surveillance Regulation corrective-action escalation workflow

Start the escalation when a test, inspection, complaint, customs suspension, authority request, online listing review, or operator assessment shows a possible failure against Union harmonisation legislation or a product risk. Record the product identity, applicable legislation, model or batch, market status, supply-chain operator, and whether the product has already reached end users.

Risk is the combination of the probability that a hazard causes harm and the severity of that harm. A product presents a serious risk only when an appropriate assessment, including normal and reasonably foreseeable use, shows that rapid authority intervention is required; the effects need not be immediate. Record the hazard, exposed users, use conditions, probability, severity, affected population, evidence limits, and assessor before using the serious-risk branch.

Where the finding matches Article 16, the authority requires the relevant economic operator to take appropriate and proportionate corrective action within the period the authority specifies. The operator-side workflow should still separate voluntary measures, taken before a specific order, from measures required by the authority.

Choose the measure by product location and risk. Withdrawal prevents a product in the supply chain from being made available; recall aims to obtain the return of a product already made available to an end user. Warnings, prior conditions, and end-user alerts under Article 16(3)(e) to (g) may be required only when the product presents a risk in certain conditions or only to certain end users.

If the operator does not take adequate corrective action, or if non-compliance or risk persists, Article 16 requires authority measures. Document the exact measure, grounds, product scope, territories affected, communication to the operator, and any public alert. Article 18 also requires the measure or decision to state its grounds and available remedies; the operator normally receives at least 10 working days to be heard. When health, safety, or another protected public interest makes a prior hearing impossible, the authority may act first but must hear the operator as soon as possible afterward and review the measure promptly.

Once corrective action is selected, the case file should show how information moved beyond the first team or first authority. Market surveillance authorities enter MSR enforcement information in ICSMS and make the rapid-alert notifications required by Article 20. Safety Gate is the current public-facing rapid alert system for dangerous non-food products. Economic operators provide the underlying facts and retain authority references; they do not create the authority record themselves.

Close the operator case only after the record identifies the affected products and territories, proves the measure was carried out, verifies that the non-compliance ended or the risk was eliminated or mitigated, reconciles remaining stock and returned units, and records the authority's closure or the owner and date for continuing monitoring.