Article 9 of the Machinery Regulation 2023/1230: the manufacturer's general obligations, one by one

Direct answer: Article 9 of Regulation (EU) 2023/1230 requires the manufacturer to design and build the machinery in accordance with the essential health and safety requirements (EHSRs) of Annex III, draw up the technical documentation set out in Annex IV, undergo the relevant conformity assessment procedure, draw up the EU declaration of conformity, affix the CE marking, keep the documentation for ten years, ensure the traceability of the product, and act immediately if it finds that machinery already placed on the market is not compliant. It is the parent provision from which almost all other obligations in the Regulation derive.

While other articles of Regulation 2023/1230 regulate specific economic operators — authorised representative, importer, distributor — Article 9 gathers in a single provision the complete catalogue of the manufacturer's duties, the manufacturer being the natural or legal person who manufactures the machinery, or has it designed or manufactured, and markets it under its own name or trademark. Knowing this catalogue in detail is the first step before delegating any task to an authorised representative, a figure covered in another article in this series.

What must the manufacturer guarantee when designing and building the machinery?

This obligation is not merely declaratory: it requires the manufacturer to carry out, or have carried out, a risk assessment that identifies all hazards applicable to the machinery, and to design and build the product taking into account the results of that assessment. Annex III sets out the general EHSRs — stability, strength of materials, ergonomics, lighting, emissions — and the specific ones by risk type, including those relating to safety-related software and components with embedded digital functions, a novelty of this Regulation compared with Directive 2006/42/EC, which it replaces.

What technical documentation does Article 9 require?

Article 9.2 requires the manufacturer to draw up the technical documentation in accordance with Annex IV and to carry out, or have carried out, the relevant conformity assessment procedure under Article 25. Where that assessment demonstrates that the machinery complies with the applicable EHSRs, the manufacturer must draw up the EU declaration of conformity and affix the CE marking.

How must the manufacturer keep the documentation and ensure traceability?

Article 9.3 sets a retention period of ten years for the technical documentation and the EU declaration of conformity, counted from the placing on the market of the machinery or, where several units are manufactured from that machinery, from the placing on the market of the last unit produced. On traceability, Article 9.6 requires the manufacturer to indicate on the machinery a type, batch or serial number, or other element allowing its identification, or — where the size or nature of the product does not allow it — to provide that information on the related product itself, on its packaging, or in an accompanying document.

What must the manufacturer do on finding non-compliant machinery already on the market?

Article 9.9 imposes a duty of immediate action: where the manufacturer considers, or has reason to believe, that machinery it has placed on the market is not in conformity with the Regulation, it must immediately take the corrective measures necessary to bring it into conformity, withdraw it, or recall it, as appropriate. Furthermore, where the machinery presents a risk, the manufacturer must immediately inform the market surveillance authorities of the Member States in which it made the machinery available, giving details of the non-compliance and of any corrective measures taken.

What other administrative obligations does Article 9 set out?

Article 9.10 requires the manufacturer to respond, with reasons, to requests for information and documentation from a competent national authority demonstrating the conformity of the machinery, in a language easily understood by that authority, and to cooperate with it, at its request, on any action taken to eliminate the risks posed by machinery it has placed on the market.

IgeraIndustria in action: checking the technical file before a CE marking

A manufacturer of automated packaging lines asked its quality manager whether the technical file for a new model met every point required by Article 9.2 before signing the EU declaration of conformity, since the engineering team suspected the risk assessment report for a recently added robotic module was missing.

Frequently asked questions about Article 9

Can the manufacturer delegate the obligations of Article 9 to a third party?

The manufacturer can delegate specific tasks by mandate to an authorised representative, under Article 13, but ultimate responsibility for the machinery's compliance with the Regulation always remains with the manufacturer. Certain obligations — such as drawing up the technical documentation — cannot be the subject of a mandate to the authorised representative.

What happens if the manufacturer is not established in the European Union?

A manufacturer established outside the EU remains subject to all the obligations of Article 9. In addition, the importer placing its machinery on the EU market must verify that those obligations have been met, under Article 14, before placing it on the market.

Does the ten-year retention period run from the design date or from the sale?

It runs from the placing on the market of the machinery or, if the manufacturer produces several units of the same model, from the placing on the market of the last unit manufactured, under Article 9.3. Not from the design date, nor from the date of the first prototype.

Can the EU declaration of conformity be signed before the technical documentation is complete?

No. Article 9.2 expressly links drawing up the EU declaration of conformity to the positive outcome of the conformity assessment procedure, which in turn requires the complete technical documentation under Annex IV. Signing it without that documentary basis amounts to an inaccurate declaration, with legal consequences for the manufacturer.

What must the manufacturer do if a national authority requests documentation?

Under Article 9.10, the manufacturer must provide, with reasons, all the information and documentation needed to demonstrate the conformity of the machinery, in a language understood by that authority, and cooperate with it on any action aimed at eliminating the risks identified.

How does IgeraIndustria help with compliance under Article 9?

IgeraIndustria lets you check in seconds what each part of Article 9 requires and cross-reference it with the manufacturer's actual technical documentation, flagging what is missing before drawing up the EU declaration of conformity and affixing the CE marking.