Article 31 of Machinery Regulation 2023/1230: Presumption of Conformity for Notified Bodies

Article 31 of Regulation (EU) 2023/1230 establishes a presumption-of-conformity mechanism: if a conformity assessment body meets the criteria of the harmonised standards EN ISO/IEC 17065 and EN ISO/IEC 17025 published in the Official Journal of the EU, it is automatically presumed to meet the requirements of Article 30, provided those standards actually cover such requirements. In practice, this simplifies and speeds up the notification process before national authorities.

What exactly does "presumption of conformity" mean?

The presumption of conformity is a legal technique from the European "new approach" that reverses the burden of proof: instead of the conformity assessment body having to demonstrate point by point before the notifying authority that it meets each of the technical and organisational requirements of Article 30, it is enough to show that it holds a valid accreditation under the corresponding harmonised standard. The notifying authority then treats the requirements covered by that standard as satisfied, without needing a further exhaustive audit of those same aspects.

This does not remove oversight: the notifying authority still verifies the elements of Article 30 not covered by the harmonised standard, and may require additional evidence. The presumption operates only "in so far as those standards cover those requirements" — a qualification that limits the scope of the simplification to what EN ISO/IEC 17065 and EN ISO/IEC 17025 actually address.

Why are EN ISO/IEC 17065 and EN ISO/IEC 17025 specifically cited?

EN ISO/IEC 17065 sets out the requirements for bodies certifying products, processes and services, covering aspects such as impartiality, technical competence, management of conflict-of-interest risks and certification procedures. EN ISO/IEC 17025 governs the competence of testing and calibration laboratories, a key aspect when the notified body must carry out or subcontract tests on machinery under Article 30. Both standards are the internationally recognised technical references for accrediting conformity assessment bodies, and their express mention in Article 31 connects the Machinery Regulation to the accreditation framework of Regulation (EC) 765/2008.

Who benefits from this presumption of conformity?

The main direct beneficiaries are the conformity assessment bodies themselves that are candidates for notification, whose notification process before the competent national authority is simplified and accelerated. But the effect extends indirectly to machinery manufacturers: the more operational, accredited notified bodies exist on the European market, the greater the available conformity assessment capacity for the Annex I categories that require the intervention of a notified body.

For the quality and compliance departments of manufacturing companies, understanding this mechanism is also relevant when selecting a notified body: verifying that the body holds EN ISO/IEC 17065 accreditation and, where applicable, EN ISO/IEC 17025, is an indicator of technical solidity that can anticipate the reliability of the certification process.

How does Article 31 relate to Article 30?

Article 30 of the Machinery Regulation sets out the substantive requirements that a conformity assessment body must meet to be notified: hierarchical and functional independence from the manufacturers it assesses, technical competence of staff, impartiality, confidentiality, civil liability insurance cover, and organisational capacity to carry out the assessment procedures described in Annex VIII. Article 31 does not replace those requirements: it presumes them met only when the body demonstrates conformity with the relevant harmonised standards, thereby acting as a bridge between the regulatory requirement (Article 30) and the simplified evidentiary mechanism (Article 31).

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Case study: Maquinària Vallès, S.L.

Maquinària Vallès, S.L., a mechanical press manufacturer in Terrassa with 42 employees, needed to certify a new line of high-force presses covered by the high-risk category of Annex I of the Machinery Regulation. Its quality department assessed three candidate conformity assessment bodies before signing the certification contract. The body ultimately selected held a valid ENAC accreditation under EN ISO/IEC 17065 since 2019, and subcontracted mechanical strength testing to a laboratory accredited to EN ISO/IEC 17025 with a specific scope in industrial machinery. Thanks to the presumption of conformity under Article 31, the Spanish notifying authority resolved this body's renewal notification in 6 weeks, compared with the 4-5 months taken by a competing body's initial notification process without that combined dual accreditation.

Does the presumption of conformity fully exempt the body from demonstrating compliance?

No. The presumption only covers the aspects actually regulated by the EN ISO/IEC 17065 and EN ISO/IEC 17025 standards. Any Article 30 requirement not addressed by those standards must be demonstrated by other means before the notifying authority.

What happens if the body only meets one of the two standards mentioned?

Article 31 allows for a partial presumption: a body may hold EN ISO/IEC 17065 accreditation without directly carrying out laboratory testing, in which case the presumption applies to the organisational and certification requirements, but the testing aspects must be demonstrated under EN ISO/IEC 17025, whether performed in-house or subcontracted.

Who verifies that the harmonised standards are actually published in the Official Journal of the EU?

The European Commission publishes in the Official Journal of the EU the references to the harmonised standards that generate a presumption of conformity under the Machinery Regulation. Only valid, published versions produce this legal effect.

Does this presumption directly affect manufacturers?

Not directly: Article 31 governs the relationship between the conformity assessment body and the notifying authority. However, it indirectly affects manufacturers because it determines the availability and technical solidity of the notified bodies they can turn to.

Can the presumption of conformity be lost after the initial notification?

Yes. If the body loses its valid accreditation under EN ISO/IEC 17065 or EN ISO/IEC 17025, it no longer benefits from the presumption and the notifying authority must directly reassess compliance with Article 30.

Are there other relevant harmonised standards besides the two cited?

Article 31 mentions EN ISO/IEC 17065 and EN ISO/IEC 17025 "in particular", indicating that they are not necessarily the only relevant harmonised standards, although they are the ones expressly identified in the legal text as the primary reference.