Article 46 of the Machinery Regulation 2023/1230: what formal non-compliance is and how it is remedied

Article 46 of Regulation (EU) 2023/1230 requires the Member State to require the economic operator to remedy the non-compliance when it detects formal defects in the CE marking, the notified body's identification number, the EU declaration of conformity, the technical documentation, the instructions or the labelling. If the operator does not correct the defect, the Member State must restrict, prohibit the making available, withdraw or recall the product from the market. It does not require an actual risk to health or safety: the documentary defect is sufficient on its own.

What distinguishes formal non-compliance from an actual risk?

Article 46 governs formal, not substantive, defects: the machinery may be perfectly safe in its design and operation, but if the CE marking is incorrectly affixed, the EU declaration of conformity does not accompany the product, or the technical documentation has gaps, the Member State must act regardless. This contrasts with the safeguard procedure for actual risk, where intervention is based on an effective danger to the health or safety of persons. Article 46 operates as a prior administrative control network: it ensures that all the documentary traceability required by the Regulation is present and correct, irrespective of whether the machinery actually works well.

How must the Member State act when it detects the defect?

The text is clear: the Member State "shall require" the relevant economic operator — manufacturer, authorised representative, importer or distributor, as applicable — to remedy the non-compliance. This is not a discretionary power but an obligation. The correction may consist of re-affixing the CE marking correctly, including the notified body's number, drawing up or rectifying the EU declaration of conformity, completing the technical documentation, or adding the missing information to the instructions and labelling. Article 46 does not itself set a fixed deadline, but it requires that the remedy take place; if it does not, the second phase of the article is triggered.

What happens if the operator does not remedy the non-compliance?

If the non-compliance persists, the Member State must take all appropriate measures to restrict or prohibit the product being made available on the market, or ensure that it is withdrawn or recalled from the market. This means that a purely documentary defect — for example, a missing declaration of incorporation for partly completed machinery — can end up blocking the sale of a technically safe product. The commercial consequences are severe: loss of market access, logistical recall costs, and reputational damage with customers and notified bodies.

Who is the responsible economic operator in each scenario?

Article 46 refers to the "relevant economic operator", which points to the chain of responsibilities set out in the Regulation: the manufacturer is responsible for the CE marking, the EU declaration of conformity and the technical documentation; the importer must verify that these elements exist before placing the machinery on the Union market; and the distributor must check that the product carries the required marking and documentation before making it available. The market surveillance authority addresses the remediation request to whoever holds the unmet obligation according to their role in the chain.

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Case study: Mecanitzats Vilardell, SL

Mecanitzats Vilardell, SL, a company based in Igualada (Barcelona) manufacturing 40 hydraulic presses a year, received an inspection from the market surveillance authority in March 2027 following a customer complaint. The inspection found two formal non-compliances under Article 46: the identification number of its notified body did not appear next to the CE marking on 12 units already distributed, and the technical documentation for that series lacked the updated risk assessment report required under the relevant annex. The authority required the remedy within a 30-day deadline. Mecanitzats Vilardell had to relabel the 12 units at the premises of three different customers, at a logistical cost of €8,400, and rebuild the technical file with the help of an external engineer, at a further €6,200. By completing the remedy within the deadline, it avoided a ban on the marketing of its entire press range, which accounted for 65% of its annual turnover.

Does Article 46 require the machinery to be dangerous in order to apply?

No. Article 46 governs formal or documentary defects, independent of whether an actual risk to health or safety exists. It is enough for the CE marking, the EU declaration of conformity or the technical documentation to be missing or incorrect for the Member State to have to act.

What deadline does the economic operator have to remedy the non-compliance?

Article 46 does not set a specific number of days in its text; it is for the Member State to determine a reasonable deadline in its request. What matters is that, if the non-compliance persists after that deadline, the restrictive measures are triggered.

What measures can the Member State adopt if there is no remedy?

It can restrict the marketing, prohibit it outright, or ensure that the product is withdrawn or recalled from the market. The choice depends on the severity and persistence of the formal non-compliance detected.

Who receives the remediation request: the manufacturer or the distributor?

It is addressed to the "relevant economic operator", meaning whoever holds the unmet obligation according to their role in the supply chain: normally the manufacturer for the marking, the declaration and the technical documentation, although importers and distributors may also be addressees depending on the defect detected.

Does an incorrect declaration of incorporation for partly completed machinery fall under this article?

Yes. Article 46 expressly covers the case where the declaration of incorporation for partly completed machinery has not been drawn up, has been drawn up incorrectly, or does not accompany the product, as one of the scenarios that require the Member State to demand a remedy.

What happens if the information in the instructions is false, not just incomplete?

Article 46 treats both scenarios the same way: both the absence of mandatory information and the presence of false information in the instructions or labelling trigger the same duty on the Member State to require a remedy.