Article 40 of Machinery Regulation 2023/1230: information obligation of notified bodies

Article 40 of Regulation (EU) 2023/1230 requires every notified body to inform its notifying authority of any refusal, restriction, suspension or withdrawal of a conformity assessment certificate, of any circumstance affecting the scope or conditions of its notification, and of any requests for information received from market surveillance authorities. In practice, this means total traceability: no machinery certificate can be \"silenced\" without the competent authority being aware of it.

What must a notified body report about the certificates it issues?

Article 40 requires the notified body to inform its notifying authority of four types of certificate-related events: the refusal of a certificate, its restriction, its suspension, or its withdrawal. It is not enough to file the decision internally: the notifying authority must have formal record of each of these four situations, because its ability to supervise whether the body still meets the requirements that justified its designation depends on this information.

This obligation closes a common gap in earlier certification systems: a certificate suspended or withdrawn due to detected non-compliance could go unnoticed by the authority, while the manufacturer kept marketing the machine relying on a certificate that was no longer valid. Under Article 40, information flows systematically and does not depend on someone expressly requesting it.

How does a change in the scope of the body's notification affect this?

Article 40 also requires notification of any circumstance affecting the scope or conditions of the body's notification. This includes, for example, changes in the categories of machinery for which the body is qualified, changes to its qualified technical staff, or any fact that calls into question its competence to assess a given type of machinery under Annex I of the Regulation.

For a manufacturer, this matters because the scope of the body's notification determines whether the certificate it issued remains valid for the manufacturer's machinery category. A change of scope not reported in time could leave manufacturers holding certificates issued outside the body's actual competence — a risk Article 40 aims to minimise through the immediate reporting obligation.

Who can request information from the notified body, and about what?

Article 40 distinguishes two information channels: what the body must report proactively, and what it must provide on request. Market surveillance authorities may request information relating to the body's assessment activities, and the body must inform its notifying authority of any such request it receives. In addition, if requested, the body must report on all conformity assessment activities carried out within the scope of its notification, as well as any other activity, including cross-border activities and subcontracting to third parties.

This dual channel is key to traceability: it controls not only what the body decides about specific certificates, but also its overall activity, including what it subcontracts and in which countries it operates. For engineering firms and consultancies managing certifications for several manufacturers, this reinforces the need to keep complete, accessible documentary records available for any request.

Why must notified bodies share results with other notified bodies?

Article 40 adds a horizontal obligation between notified bodies: they must share information on negative assessment results and, if requested, also on positive results, with other bodies carrying out similar assessment activities covering similar machinery. This prevents a manufacturer refused a certificate by one body from simply approaching another notified body without that body being aware of the reasons for the earlier refusal.

This peer-to-peer information exchange turns the system of notified bodies into an interconnected network, rather than a set of entities operating in isolation. It is a direct safeguard against \"certificate shopping\" in less demanding jurisdictions or entities — a risk of particular concern in high-risk machinery sectors regulated by Regulation (EU) 2023/1230.

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Case study: Maquinària Industrial Bages, SL and the withdrawal of a certificate

Maquinària Industrial Bages, SL, a manufacturer of hydraulic presses in Manresa, had obtained an EU-type examination certificate for a new range of 200-tonne presses through a German notified body. Eight months later, the body detected during a follow-up audit that the safety interlock system on one of the 14 units manufactured did not meet the corresponding essential requirement of Annex III. The body suspended the certificate for that specific configuration and, in accordance with Article 40, notified its notifying authority of the suspension within 5 working days, detailing the exact technical reason.

At the same time, the German body shared the negative result of this assessment with three other notified bodies assessing similar hydraulic presses in the EU, preventing Maquinària Industrial Bages from attempting to obtain a new certificate from another entity without that entity knowing the history. The manufacturer had to correct the interlock system on all 14 units and request a new assessment before resuming marketing.

What about subcontracting and cross-border activities?

Article 40 requires that, if requested, the notified body also report on any other activity carried out within the scope of its notification, expressly including cross-border activities and subcontracting. This matters because many notified bodies operate in several Member States or subcontract specific tests to external laboratories, and the notifying authority needs full visibility of this chain in order to effectively supervise the quality of the conformity assessments carried out.

For the manufacturer, this means that its notified body's subcontracting history is not a black box: the notifying authority can demand this information at any time, adding a further layer of control over the reliability of the certificate ultimately received.

Within what timeframe must the notified body inform its authority?

Article 40 does not set an exact numerical deadline for each type of communication, but the obligation is understood as immediate in the case of certificate decisions (refusal, restriction, suspension, withdrawal) and changes in the scope of the notification, since these are circumstances that directly affect the validity of certificates in circulation.

Must the notified body report even if the certificate remains valid?

Yes, if requested. Article 40 distinguishes between proactive communication (for the four certificate scenarios and for scope changes) and on-demand communication (for the remaining conformity assessment activities, including those carried out on certificates that remain valid).

Who must the notified body inform about negative results?

Other notified bodies carrying out similar conformity assessment activities covering similar machinery, not any notified body in general. Article 40 limits this exchange to entities with comparable technical competence over the same type of machinery.

Are positive results always shared between notified bodies?

Not automatically. Article 40 establishes that negative results are shared proactively, while positive results are only shared if expressly requested by another notified body with similar activity.

How does Article 40 relate to market surveillance?

Article 40 creates an information bridge between market surveillance authorities and the notifying authority: when a market surveillance authority requests information from the notified body about its assessment activities, the body must inform its own notifying authority of that request, ensuring both authorities have a complete view of any issues.

Does Article 40 cover subcontracting to external laboratories?

Yes. Article 40 expressly mentions that, if requested, the body must report on any other activity carried out within the scope of its notification, including cross-border activities and subcontracting, which covers collaboration with external laboratories or entities for specific parts of the assessment.