Article 43 of Machinery Regulation 2023/1230: national procedure for products presenting a risk

Article 43 of Regulation (EU) 2023/1230 establishes that, when a market surveillance authority has sufficient reason to believe that a machine presents a risk to the health or safety of persons, it must assess the product against all applicable requirements, require the economic operator to take corrective action within a reasonable period and, if the operator fails to act or the non-compliance persists, prohibit, restrict, withdraw or recall the product from the market, immediately informing the Commission and the other Member States.

What triggers the Article 43 procedure?

The trigger is that the market surveillance authority has "sufficient reason to believe" that a machine covered by the Regulation presents a risk to the health or safety of persons. Absolute certainty of the risk is not required before acting: a reasonable indication is enough, and it may come from a complaint, an inspection, a reported accident, a market analysis or information from another Member State. This is the entry point to the safeguard mechanism set out in the market surveillance chapter of the Regulation.

From that point, the authority is obliged to carry out an assessment of the product covering all relevant requirements, not just the aspect that gave rise to the suspicion. This involves reviewing the technical file, the declaration of conformity, the instructions and, where appropriate, additional tests on the physical machine.

What must be required of the economic operator?

Once the risk is confirmed, the authority must require the relevant economic operator — manufacturer, authorised representative, importer or distributor, depending on who is in a position to act — to take all appropriate corrective action within a reasonable period. The article does not set a specific number of days, leaving it to the authority to set a period proportionate to the severity of the risk and the complexity of the correction required.

Corrective action can range from technical modifications to the machine to updating the instructions, reinforcing guards, or running warning campaigns aimed at users. The legal objective is single: the product must stop presenting the risk that was detected.

What happens if the operator does not correct in time?

If the economic operator does not take adequate corrective action, or if the non-compliance persists despite having taken it, the authority must move to more severe provisional measures: prohibit or restrict the making available of the machine on the market, withdraw it from the market, or recall it from end users. This escalation is not discretionary in its existence — the article imposes it — although it is discretionary in its specific intensity, which will depend on the severity of the residual risk.

Who must be informed of the measures adopted?

The article closes the loop with a transparency obligation: the authority must immediately inform the European Commission and the other Member States of the measures adopted. This communication makes it possible to activate, where appropriate, the European coordination mechanisms that prevent a product withdrawn in one country from continuing to circulate freely in another.

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Case study: Maquinària Vallès, S.L.

Maquinària Vallès, S.L., a manufacturer of sheet metal folding machines in Sabadell, receives a communication in March 2027 from the regional market surveillance authority: two incidents reported by different customers point to a fault in the interlocking of the movable guard on a model marketed since 2026. The authority opens an assessment covering the 47 essential safety requirements applicable to that type of machine and finds that the interlocking system does not meet the required performance level. The company is given a 30-day period to submit corrective action. Maquinària Vallès redesigns the interlocking, updates the technical file, and notifies the 63 customers who purchased the 118 units sold. After passing the authority's subsequent review, the case does not reach the market withdrawal stage; the matter is closed without the need for notification to the Commission.

What counts as "sufficient reason to believe" there is a risk?

The article does not require full proof of the risk before acting. A reasonable and well-founded indication — a complaint, an accident, an inspection — is enough for the authority to be obliged to begin the assessment provided for.

How long is the "reasonable period" for corrective action?

Article 43 does not set a number of days. It is for the market surveillance authority to determine it, taking into account the severity of the risk and the technical complexity of the correction required.

What happens if the operator corrects but the risk persists?

The article itself addresses this scenario: if the non-compliance persists despite the measures taken, the authority must move to the provisional measures of prohibition, restriction, withdrawal or recall, just as it would if no action had been taken at all.

Who can be the "relevant economic operator"?

The Regulation distinguishes between manufacturer, authorised representative, importer and distributor. Article 43 directs the requirement to whichever party is appropriate, depending on the nature of the non-compliance and its position in the supply chain.

Is it mandatory to notify the Commission even if the problem is resolved quickly?

The obligation to immediately inform the Commission and the other Member States refers to the measures adopted by the authority, not to every initial indication of risk. If the operator corrects the issue before the authority reaches the stage of adopting provisional measures, this European notification obligation does not necessarily apply in the same terms.

Can an authority withdraw a machine directly without first requiring corrective action?

The text of Article 43 establishes a sequence: first assessment, then a requirement for corrective action, and only if this is not adopted or the non-compliance persists does escalation to prohibition, restriction, withdrawal or recall follow.