Article 38 of Machinery Regulation 2023/1230: operational obligations of notified bodies

Article 38 of Regulation (EU) 2023/1230 establishes that notified bodies must apply the conformity assessment procedures set out in Annexes VII, IX and X in a manner proportionate to the size of the undertaking, the sector, its structure and the degree of technological complexity of the machinery, but without ever lowering the rigour or the level of protection required. If they detect non-compliance with the essential requirements of Annex III, they must require corrective action and must not issue the certificate until the deficiencies have been remedied, or must suspend and withdraw a certificate already issued if the manufacturer fails to correct the problem.

What does it mean that proportionality does not lower the rigour?

Article 38 introduces a principle of operational proportionality: the notified body must adapt the depth, timeline and approach of its assessment procedures — those described in Annex VII (EU-type examination), Annex IX (full quality assurance) and Annex X (unit verification) — to the size of the manufacturing undertaking, the industrial sector in which it operates, its organisational structure and the specific technological complexity of the machinery being assessed. This means, for example, that the documentation required of an artisanal manufacturer of agricultural machinery does not have to replicate exactly the same format as that of a large manufacturer of automated production lines. However, the article itself closes off any lax interpretation: this procedural adaptation can never translate into a reduction of the technical rigour or the level of protection the Regulation requires. In other words, proportionality affects "how" the assessment is carried out, never "how much" is required.

What must a notified body do if it detects non-compliance?

When the notified body finds, during the assessment, that the manufacturer has not met the essential health and safety requirements set out in Annex III, or that the machinery does not conform to the applicable harmonised standards invoked to presume conformity, Article 38 obliges it to require the manufacturer to take corrective action that is appropriate and proportionate to the deficiency detected. Until that corrective action has been carried out and verified, the body cannot issue the EU-type examination certificate or the quality system approval decision. This sequence — detection, requirement for correction, verification, and only then issuance — is the backbone of the quality control the Regulation imposes on the entire certification process for the high-risk machinery listed in Annex I.

What happens if the non-compliance is detected after the certificate has been issued?

Article 38 also covers the post-certification scenario: if, following ongoing surveillance of the quality system or a follow-up audit, the notified body finds that the non-compliance persists and the manufacturer has not corrected the situation, it has the power — and the obligation — to restrict the scope of a certificate already issued, suspend it temporarily, or withdraw it permanently. This chain of graduated measures allows the body to act with proportionality in the reaction phase as well: a minor deviation may be resolved with a restriction of scope, while a serious or repeated non-compliance justifies full withdrawal of the certificate, leaving the machinery without conformity coverage until the issue is resolved.

Who bears the operational cost of this reinforced control?

In practice, the manufacturer is the one who bears the direct cost of the corrective action required by the notified body: repeating tests, updating the technical file, reinforcing process controls, or modifying the design of the machinery. The later the gap against Annex III or the harmonised standards is detected, the more expensive it becomes to correct — especially if the certificate had already been issued and must be suspended while the remediation is carried out, with the resulting commercial disruption. That is why quality departments at manufacturers of Annex I machinery need to get ahead of these requirements before the notified body arrives, not after.

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Case study: Maquinària Vallès SL and the quality assurance audit

Maquinària Vallès SL, a manufacturer of hydraulic press brakes based in Sabadell with 42 employees, underwent the Annex IX procedure before its notified body to renew the approval of its quality system. During the audit, the body found that 3 of the 18 welding control procedures did not include traceable records of the non-destructive tests required by the harmonised standard applicable to welded structures on press brakes. Applying the proportionality criterion of Article 38 — given the size of the SME — the body granted a 45-day period to implement documented corrective action, instead of requiring an immediate full audit, but kept the level of technical demand on the tests identical. Maquinària Vallès submitted the correction plan within 30 days, with 3 new traceability records per production batch, and the body issued the approval decision without restrictions. The total cost of the delay was 6 calendar weeks and around €8,400 in engineering hours — far less than what a certificate suspension after the machinery had already reached the market would have cost.

Does the proportionality in Article 38 let SMEs pass less demanding checks?

No. The article is explicit: the adaptation refers to the procedural approach — how the audit is organised, what documentation is requested depending on the company's structure — but the level of protection and technical rigour required are identical for any manufacturer, large or small.

Which annexes govern the procedures Article 38 refers to?

The article expressly refers to Annexes VII, IX and X, which correspond respectively to EU-type examination, full quality assurance, and unit verification — three of the conformity assessment procedures applicable to the high-risk machinery listed in Annex I.

Can a notified body issue the certificate and require correction afterwards?

No, not under Article 38. The text is clear: as long as the deficiencies detected against Annex III or the harmonised standards have not been remedied, the body must not issue the certificate or the approval decision.

What is the difference between restricting, suspending and withdrawing a certificate?

Although Article 38 mentions these as graduated options without detailing separate procedures, restricting means limiting the certificate's scope to certain models or conditions; suspending means rendering it temporarily without effect while the non-compliance is corrected; and withdrawing means cancelling it permanently when the lack of correction persists.

Which machinery does this article directly affect?

It affects manufacturers of machinery and related products subject to conformity assessment procedures involving a notified body under Annexes VII, IX or X — typically the high-risk machinery categories listed in Annex I of the Regulation.

Must the manufacturer know the proportionality criterion the body will apply in advance?

The Regulation does not require the notified body to publish its proportionality criterion in advance, so the manufacturer should be prepared for any depth of audit, knowing that the technical bar — Annex III and the harmonised standards — will always be the same.