Article 32 of Machinery Regulation 2023/1230: use of subcontractors and subsidiaries by notified bodies

Article 32 of Regulation (EU) 2023/1230 sets out when and how a notified body may subcontract conformity assessment tasks or make use of a subsidiary. The condition is twofold: the subcontracted entity must meet the requirements of Article 30, and the notified body must inform its notifying authority. In practice, this means that if your machinery has been assessed by a third party engaged by the notified body, the original notified body remains the sole legal party responsible to you and to the market surveillance authority.

What does Article 32 require before subcontracting an assessment?

Before delegating any conformity assessment task, the notified body must verify that the subcontractor or subsidiary meets the same competence, independence and impartiality requirements demanded of any notified body under Article 30. A commercial agreement is not enough: the notified body must document that verification and pass it on to its notifying authority, which may demand additional evidence or even object to the use of that particular subcontractor.

This requirement addresses a recurring problem under the previous CE marking regime: certificates formally issued by an accredited body, but whose actual technical work had been delegated to third parties with no control or traceability. Article 32 closes that gap by requiring the subcontracting chain to be documented and auditable at any time.

Who is responsible if the subcontractor's work fails?

The notified body itself, in full. Article 32 explicitly establishes that subcontracting or the use of a subsidiary does not dilute or transfer responsibility: the notified body that signs the conformity assessment certificate remains fully liable for the work carried out, regardless of where the subcontractor is established. For a machinery manufacturer or importer, this means that any claim over a defective certificate is always directed against the notified body, never directly against its subcontractor.

Does the client need to give consent to the subcontracting?

Yes, explicitly. Article 32 makes any subcontracting or use of a subsidiary conditional on the prior agreement of the client — that is, the manufacturer requesting the conformity assessment of its machinery. This consent should be reflected in the assessment contract, and it is a point that quality and engineering departments must review before signing any agreement with a notified body that works with a network of subcontractors.

If your contract with the notified body does not mention the possibility of subcontracting, or does not explicitly authorise it, the body cannot turn to third parties for your file without asking you for authorisation again.

What documentation must the notified body keep on the subcontractor?

Article 32 requires the notified body to keep at the disposal of the notifying authority all documentation relating to the assessment of the subcontractor's or subsidiary's qualifications, as well as the work actually carried out by them. This includes the technical competence file of the subcontracted entity, the criteria used to verify its compliance with Article 30, and the reports on the specific task performed. This documentation is what allows the notifying authority to audit, at any time, whether the subcontracting chain complies with the Regulation.

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Case study: Maquinària Ribera, S.L.

Maquinària Ribera, S.L., a manufacturer of hydraulic presses in Vic (Barcelona), engaged a German notified body to assess the conformity of a new 30-tonne pressing line under Annex I. The notified body, facing a heavy workload, proposed subcontracting the structural strength test to an accredited laboratory in Poland. Before accepting, Maquinària Ribera's quality department demanded two documents: the Polish laboratory's accreditation under Article 30 and written confirmation that the German notifying authority had been informed of the subcontracting. The notified body took an additional 9 days to deliver both documents, but thanks to that contractual requirement, Maquinària Ribera avoided receiving a potentially challengeable certificate: without that signed prior agreement, any subsequent dispute would have called into question the validity of the entire technical file before the European market.

Can a notified body subcontract any assessment task?

Article 32 does not distinguish by type of task, but it makes any subcontracting conditional on the subcontractor's compliance with Article 30 and the client's prior agreement. Without both requirements, the subcontracting is not valid under the Regulation.

What is the difference between a subcontractor and a subsidiary for the purposes of Article 32?

Article 32 treats both figures equivalently: whether it is a subcontracted third party or a subsidiary of the notified body itself, they are both required to meet Article 30 and are both subject to the same obligation to inform the notifying authority.

Can the manufacturer refuse to have its file subcontracted?

Yes. Article 32 requires the client's prior agreement as a condition for subcontracting, which means the manufacturer can refuse to allow a particular subcontractor to intervene in its technical file.

Who is liable if the subcontractor's test is defective?

The notified body that engaged or authorised the subcontractor. Article 32 establishes that responsibility for tasks performed by subcontractors or subsidiaries rests fully with the notified body.

Does it matter where the subcontractor is established?

No, for the purposes of liability. Article 32 expressly states that the notified body takes full responsibility for subcontracted tasks regardless of where the subcontractor or subsidiary is established.

What documentation can the notifying authority request about the subcontracting?

The documentation relating to the assessment of the subcontractor's or subsidiary's qualifications, and of the work carried out by them, which Article 32 requires to be kept at the disposal of the notifying authority at all times.

Can the notifying authority prevent a specific subcontracting arrangement?

Article 32 requires the notified body to inform it of the subcontracting; this information allows the notifying authority to exercise its supervisory function over the body, including reviewing the subcontractor's or subsidiary's compliance with Article 30.