What corrective action can be required?
Regulation (EU) 2019/1020 defines as action by an economic operator to end non-compliance, either because a market surveillance authority requires it or because the operator acts on its own initiative. A is corrective action that was not required by an authority.
Apply this MSR route only to products covered by Union harmonisation legislation and only to the extent that the applicable sector legislation does not contain specific provisions with the same objective that regulate the same aspect more specifically. Identify the product, sector act, economic-operator role, Member State authority, affected market, and provision before selecting an action.
Authority action starts when the authority finds that the product, under intended or reasonably foreseeable use and when properly installed and maintained, is liable to compromise user health or safety, or does not conform to applicable Union harmonisation legislation. The authority must then require the relevant economic operator to take appropriate and proportionate within a period specified by the authority.
The required action can include bringing the product into compliance, preventing it from being made available, withdrawing or recalling it and alerting the public, destroying or rendering it inoperable, adding suitable risk warnings, setting prior conditions for market availability, or alerting end users at risk. Warnings, prior conditions, and end-user alerts under Article 16(3)(e) to (g) are available only where the product presents a risk in certain conditions or only to certain end users.
- Classify the problem first: formal non-compliance, product risk, , missing Article 4 operator or documentation, or a sector-specific defect. Record the evidence and legal provision supporting that classification.
- Name the responsible actor and action: manufacturer, importer, distributor, authorised representative, fulfilment service provider, or another operator under the applicable product law; compliance fix, stop-sale, withdrawal, recall, warning, destruction, or another proportionate measure.
- Set the population and deadline: models, batches, serial numbers, software versions, listings, Member States, supply-chain locations, units already with end users, authority-set completion date, and internal owner.
- Close the action with evidence: corrected technical or labelling records, listing changes, stock quarantine, distributor confirmations, retrieval totals, customer notices, destruction records, test results, authority correspondence, and any ICSMS or rapid-alert reference.
- Treat operator-led fixes as when they bring non-compliance to an end; treat them as voluntary measures only when they were not required by the authority.
- Escalate from operator action to authority restriction when the operator fails to act, the non-compliance remains, or the risk persists.
- Keep the action proportionate to the product, the non-compliance, and the actual or potential harm identified by the authority.
- For an authority measure, record its exact grounds, the national remedies and time limits, and the hearing history. Article 18 normally allows at least 10 working days to be heard before the measure, unless urgency requires the authority to act first and review the measure promptly after the operator is heard.
What corrective actions can market surveillance authorities require under Regulation (EU) 2019/1020?
They can require proportionate action to end non-compliance or eliminate the risk, including compliance fixes, stopping further availability, withdrawal, recall, public or end-user warnings, prior conditions for making the product available, destruction, or rendering the product inoperable. Warnings, prior conditions, and end-user alerts under Article 16(3)(e) to (g) may be required only where the risk arises only in certain conditions or only to certain end users. If the operator does not act or the risk remains, authorities must ensure withdrawal or recall, or prohibit or restrict the product's availability on the market.
When does a matter under EU MSR?
A is that an economic operator takes without being required to do so by a market surveillance authority. If a serious-risk product has already been made available on the market and the operator communicates the voluntary measure to the authority, Article 20 requires the authority to notify the Commission immediately.
Citations (1)
- Regulation (EU) 2019/1020 on market surveillance and compliance of products
Supports the Article 2 scope limitation, definitions of corrective action and voluntary measure, Article 16 triggers, and the corrective measures that may be required.
corrective action means any action taken by an economic operator to bring any non-compliance to an end