FAQEU

EU MSR FAQ Corrective Action

Under Regulation (EU) 2019/1020, corrective action is triggered when a covered product presents a relevant risk or does not conform to Union harmonisation legislation.

The answer depends on whether the operator remedies the issue voluntarily or after an authority request, whether the risk persists, and whether serious-risk notification is required.

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Author
Sorena AI
Published
May 9, 2026
Updated
May 9, 2026
Questions
2

Structured answer sets in this page tree.

Primary sources
2

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated May 9, 2026
Overview

Market surveillance authorities can require appropriate and proportionate corrective action when a product covered by Union harmonisation legislation is liable to compromise health or safety, or does not conform to applicable EU product rules. Corrective action may also be taken by the economic operator on its own initiative.

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2 of 2 questions
Question 1

What corrective action can be required?

Regulation (EU) 2019/1020 defines corrective action 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 voluntary measure is corrective action that was not required by an authority.

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 corrective action 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.

  • Treat operator-led fixes as corrective action 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.
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Question 2

How does serious risk change the response?

A product presents a serious risk when a risk assessment, considering normal and foreseeable use, shows that the probability and severity of harm require rapid authority intervention. The fact that safer products exist, or that a higher level of safety is technically feasible, is not enough by itself to classify the product as a serious risk.

For serious risk, market surveillance authorities must ensure withdrawal or recall where no other effective means can eliminate the risk, or prohibit the product from being made available on the market. They must notify the Commission immediately under the Regulation's rapid information exchange process, including available details on product identification, origin and supply chain, the risk, national measures, and any voluntary operator measures.

  • Record the risk assessment basis: hazard, likelihood, severity, normal and foreseeable use, and why rapid intervention is or is not required.
  • Record the measure chosen: compliance fix, withdrawal, recall, prohibition, restriction, public warning, end-user alert, or online-interface action where applicable.
  • Record follow-up in the authority-facing file: authority correspondence, operator corrective actions, test reports, supply-chain details, public notices, recall evidence, and ICSMS or rapid-alert references.
Citations
Primary sources

References and citations

ICSMS market surveillance information system
icsms.org
Referenced sections
  • Grounding source for the role of ICSMS as the market-surveillance communication platform used for product investigations, measures, and authority information exchange.
"comprehensive communication platform for market surveillance on non-food products"
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