Article 36 of Machinery Regulation 2023/1230: changes to notified body notifications

Article 36 of Regulation (EU) 2023/1230 establishes that, if a notified body no longer meets the requirements of Article 30 or fails to fulfil its obligations under Article 38, the notifying authority must restrict, suspend or withdraw the notification depending on the seriousness of the failure, and must inform the European Commission and the other Member States immediately. In practice, this means that a conformity assessment certificate issued by that body can be called into question overnight, forcing the manufacturer to react quickly.

What situations trigger Article 36?

Article 36 is triggered in two specific scenarios: when a notified body no longer meets the technical competence, independence and impartiality requirements set out in Article 30, or when it fails to fulfil the operational obligations imposed on it by Article 38 (for example, in matters of surveillance, cooperation with other bodies or reporting of results). This is not a minor or one-off infringement: it is a structural deterioration of the body's capacity to carry out reliable conformity assessments of machinery under Regulation 2023/1230.

The notifying authority of each Member State is responsible for detecting these situations, usually through periodic audits, manufacturer complaints or alerts from other notified bodies. Once the failure is confirmed, the authority has no discretion not to act: Article 36 imposes the obligation to restrict, suspend or withdraw the notification depending on the seriousness of the failure.

How is it decided whether to restrict, suspend or withdraw?

The Regulation graduates the response according to the magnitude of the problem. Restriction reduces the scope of the notification to certain categories of machinery or assessment procedures, allowing the body to continue operating in the areas where it maintains demonstrated competence. Suspension temporarily halts all of the body's activity until it corrects the deficiencies detected. Withdrawal is the most severe measure: it permanently removes the body's capacity to act as a notified body under the Machinery Regulation.

In all cases, Article 36 requires that the European Commission and the other Member States be informed immediately. This communication is not a mere administrative formality: it alerts the entire internal market to the reduced or non-existent reliability of the certificates issued by that body, which can affect manufacturers operating in several EU countries.

What happens to technical files already in the body's hands?

Article 36 does not merely regulate the sanction applied to the body: it also protects the continuity of manufacturers' files. In the event of restriction, suspension, withdrawal or cessation of activity, the orderly transfer of files to another notified body must be guaranteed, or their availability to notifying and market surveillance authorities preserved. This prevents a manufacturer from losing access to the conformity assessment documentation for its machinery simply because the body that managed it has ceased its activity or lost its notification.

For quality and compliance departments at manufacturing companies, this implies a real operational risk: if the notified body they work with suffers a restriction or suspension, the certification process for their machines can be paralysed while the transfer of the file is resolved. Anticipating this risk through active monitoring of the status of notified bodies is a risk-management practice that more and more technical departments are adopting.

Who is responsible for monitoring and acting on notified bodies?

Responsibility lies with the notifying authority designated by each Member State, which is the entity responsible for assessing, notifying and supervising notified bodies within its territory. This authority must act proactively, without waiting for the notified body itself to report its deficiencies, and must coordinate with the Commission and with the notifying authorities of other Member States to ensure a consistent response across the single market.

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Case study: Maquinària Vallès, S.L.

Maquinària Vallès, S.L., a manufacturer of industrial packaging machinery based in Terrassa, had 14 machine models certified through a notified body headquartered in another Member State. In March 2027, the notifying authority of that State detected, following an audit, that the body had stopped meeting the independence requirements of Article 30 in two of its technical departments. The notifying authority restricted the body's notification, excluding those two areas, and communicated the decision to the Commission and the other Member States within 5 working days. Maquinària Vallès' compliance team, not having been monitoring the body's status, took 11 days to learn of the restriction, which delayed the renewal of 3 certificates and forced the transfer of technical files to an alternative body, at an estimated additional cost of 6,200 euros and a delay of almost 6 weeks in two product launches.

What is the difference between restriction and suspension?

Restriction limits the scope of the notification to certain categories of machinery or procedures, whereas suspension temporarily halts all of the body's activity until the deficiencies are corrected.

Who decides whether to restrict, suspend or withdraw the notification?

The decision lies with the notifying authority of the Member State that notified the body, based on the seriousness of the failure detected in relation to Articles 30 or 38.

Must other EU countries be informed if a notified body is restricted?

Yes, Article 36 requires the notifying authority to inform the European Commission and the other Member States immediately, whatever measure is adopted.

What happens to technical files if the body ceases its activity?

Their orderly transfer to another notified body must be guaranteed, or their availability to notifying and market surveillance authorities preserved.

Can a notified body regain its notification after a suspension?

Article 36 regulates restriction, suspension and withdrawal, as well as the protection of files; recovery of the notification will depend on the body correcting the deficiencies that led to the suspension, as assessed by the notifying authority.

What Article 30 requirements can lead to a restriction or withdrawal?

Any failure to meet the requirements imposed on notified bodies under Article 30 —relating to technical competence, independence and impartiality— can lead to the application of Article 36.

How does this affect a manufacturer that already holds valid certificates?

If the body that issued the certificate is restricted, suspended or withdrawn, the manufacturer must check whether its file is affected and, if so, arrange its orderly transfer to another notified body as provided for in Article 36.