Article 37 of the Machinery Regulation 2023/1230: challenging the competence of notified bodies

Article 37 of Regulation (EU) 2023/1230 establishes that the European Commission may investigate, on its own initiative or at the request of a party, any doubt about the competence of a notified body or about whether it continues to meet the requirements applicable to it. If it detects non-compliance, it may require the notifying Member State to take corrective measures, including withdrawal of the notification, by means of an implementing act adopted in accordance with the advisory procedure of Article 48(2). In practice, this means that no conformity assessment certificate is immune from review if the issuing body loses its authorisation.

What can trigger a Commission investigation into a notified body?

Article 37 does not require a formal threshold to open the investigation: it is enough that "doubts are raised" about the body's competence or about its continued fulfilment of the applicable requirements. These doubts may arise on the Commission's own initiative — that is, at its own instigation following audits, market surveillance reports or incidents detected in several Member States — or at the request of a party, when a manufacturer, a competitor, another notified body or even a surveillance authority formally raises the issue.

In practice, the most common triggers are certificates issued without sufficient technical evidence, assessment staff lacking the qualifications required under the regulation's criteria, irregular subcontracting of assessment tasks, or inconsistencies detected when comparing the technical file with the declaration of conformity. The Article 37 mechanism acts as a safety net against notified bodies that, after their initial designation, subsequently fail to continue meeting the technical competence criteria.

How is the corrective procedure structured vis-à-vis the notifying Member State?

The Commission does not withdraw the notification directly: Article 37 provides that it requires the notifying Member State to take "the necessary corrective measures". This respects the allocation of powers within the notification system, in which each Member State retains primary responsibility for the bodies it designates and notifies to the Commission and the other Member States. The Commission acts as a second-level supervisor that can force action when the Member State does not correct the problem on its own initiative.

The formal channel for requiring this correction is the implementing act adopted in accordance with the advisory procedure of Article 48(2). This procedure, more agile than the examination procedure, involves a committee of Member State representatives issuing a non-binding opinion before the Commission adopts the act, allowing it to react relatively quickly without the decision being blocked in the event of disagreement.

Who can request the investigation and what are the consequences of withdrawing the notification?

The legal text refers to "at the request of a party" — a broad formula that in practice includes manufacturers who suspect a body's technical soundness, other notified bodies that detect irregular practices within their field of activity, and national market surveillance authorities that find non-compliant products despite an apparently valid certificate. Any of these actors can bring the doubt to the Commission's attention, which then decides whether to open the investigation.

If the investigation concludes with withdrawal of the notification, the certificates already issued by that body do not automatically disappear from the legal order, but they come under heightened suspicion: market surveillance authorities may require manufacturers to provide additional evidence of conformity, and a manufacturer that relied on that body for new assessments must seek another notified body, with the resulting delay and cost. For a quality department, this turns the choice of notified body into a risk decision, not merely one of price or lead time.

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Case study: Maquinària Industrial Bages, S.L.

Maquinària Industrial Bages, S.L., a manufacturer of hydraulic presses in Manresa, had certified 14 machine models over three years with the same notified body. When its quality department discovered, through an industry bulletin, that this body was being investigated by the Commission under Article 37 for deficiencies in the qualification of its assessment staff, the company found itself with 14 certificates in a state of uncertainty and two export projects pending on that documentation. Technical management had to internally audit each technical file, hire another notified body to revalidate the three most critical certificates (at an additional cost of €27,400 and eleven weeks of delay) and proactively notify its customers in France and Germany. The episode led the company to implement a quarterly verification protocol for the status of its notified bodies, supported by IgeraIndustria so as not to depend again on a late external warning.

Why the advisory procedure of Article 48(2) rather than the examination procedure?

The choice of the advisory procedure, rather than the examination procedure used for other more onerous decisions under the regulation, responds to the need to give the Commission rapid room for manoeuvre in the face of a risk to the safety of machinery users. Under the advisory procedure, the committee issues an opinion that the Commission must take "into utmost account", but which does not prevent it from adopting the implementing act even if the opinion is unfavourable. This speeds up the withdrawal of notifications when the evidence of incompetence is clear, without the qualified-majority obstacles of the examination procedure.

For manufacturers, this procedural agility means that the risk of relatively quickly losing their notified body is real and not merely theoretical, reinforcing the need to actively monitor the status of the bodies they work with, rather than assuming that a notification valid today will remain so throughout the product's entire life cycle.

Can anyone request an investigation under Article 37?

The article refers to "at the request of a party" without restricting who may raise the doubt, so manufacturers, other notified bodies, market surveillance authorities or any third party with a legitimate interest can bring the case to the Commission.

What happens to certificates issued before the notification is withdrawn?

Article 37 does not expressly regulate the retroactive validity of certificates; it establishes withdrawal of the notification as the corrective measure, which in practice obliges market surveillance authorities and manufacturers themselves to reassess the reliability of those certificates on a case-by-case basis.

Is the Member State obliged to comply with the Commission's requirement?

The implementing act adopted under Article 48(2) is binding on the notifying Member State, which must take the required corrective measures, including withdrawal of the notification if so determined.

What is the difference between "competence" and "compliance with requirements" in this article?

Competence refers to the body's technical capacity to correctly carry out conformity assessments, while compliance with requirements refers to the organisational, independence and impartiality conditions that the regulation requires to be maintained continuously after initial designation.

Can the Commission act without any complaint being filed?

Yes, Article 37 expressly permits investigation "on its own initiative", so the Commission can open the procedure based on its own supervisory activities, without requiring a third party to formally raise the doubt.

What should a manufacturer do while an investigation into its notified body is ongoing?

Article 37 does not impose direct obligations on the manufacturer during the investigation, but reasonable prudence requires documenting additional evidence of conformity and exploring certification alternatives, given that withdrawal of the notification can occur relatively quickly under the advisory procedure.