Can the manufacturer carry out internal control without a notified body under Part B?

Yes, but subject to a strict condition that Article 25(3) sets out expressly. For the categories in Annex I Part B, the manufacturer may opt for internal production control (Module A, Annex VI) only if it designs and manufactures the machinery in accordance with the harmonised standards or common specifications specific to that category that cover all the applicable essential health and safety requirements. If the machinery has not been designed entirely in accordance with those specific standards — for example, because the manufacturer has developed its own solution not covered by any type-C standard — then it must mandatorily resort to one of the other three routes (B+C, H or G), exactly as if the machinery were in Part A.

This distinction connects directly with the presumption-of-conformity system we already explained in our analysis of Article 20: only harmonised standards whose reference has been published in the Official Journal of the European Union confer that presumption and, therefore, enable the self-assessment route without an independent third party.

What happens if my machine is not listed in Annex I?

Article 25(4) resolves the most common case in practice: the vast majority of industrial machinery — conveyor belts, collaborative robots without self-evolving safety functions, conventional packaging lines, agricultural machinery not included in specific listings — does not appear in either Part of Annex I. For all of these, the procedure is single and mandatory: internal production control (Module A, Annex VI), without the involvement of a notified body. The manufacturer assumes, under its exclusive responsibility, the preparation of the technical file under Annex IV Part A, control of the manufacturing process, and drafting of the EU Declaration of Conformity — as we detail in our article on Article 16 of the Regulation.

A practical case: the hydraulic press with an AI vision system

Metalúrgica Ferran S.L., a fictitious manufacturer of hydraulic presses for sheet metal forming, incorporated in 2026 a machine-learning-based artificial vision system to detect the presence of the operator's hands in the pressing zone and stop the cycle before impact. The press itself — without the vision system — is listed in Annex I Part B, point 9 (cold-work metal presses with a stroke greater than 6 mm and a speed greater than 30 mm/s), which in principle would have allowed internal control if the relevant harmonised EN standards were applied. However, the engineering department identified that the hand-detection system itself, since it based its safety function on a machine-learning model with retraining capability, fell within point 5 of Annex I Part A. This required Metalúrgica Ferran to follow the procedure under Article 25(2) — they chose the B+C route, EU type-examination followed by conformity to type — for the whole assembly, instead of the internal control they had originally budgeted for.

IgeraIndustria in action: automatic classification of the assessment procedure

Can more than one procedure be combined in the same machine?

Yes, when a complex machine integrates safety components of a different nature. It is common for a production line with several stations to combine, for example, a self-evolving safety component under Annex I Part A (which requires B+C, H or G) with the rest of the installation classified under Part B or not listed at all. In these cases, the criterion consistently applied by notified bodies is that the most demanding procedure governs the whole: if any part of the machine requires the involvement of an independent third party, the machine as a whole — not just the component — must be assessed under that procedure, since the EU Declaration of Conformity covers the machine as a functional unit, not its components separately.

Frequently asked questions about Article 25

Can I freely choose between the three procedures in Article 25.2?

Yes, the Regulation establishes no hierarchy between B+C, H and G for the Part A categories: the manufacturer decides which best fits its production model. The B+C route is usually the most common for series production of a stable model; Module H (full quality assurance) is more efficient for manufacturers with wide ranges and frequent design changes; Module G (unit verification) is the natural option for bespoke machinery or one-off production.

How long is an EU type-examination certificate valid?

Annex VII establishes that the period of validity of a newly issued or renewed EU type-examination certificate may not exceed five years. Before that date, the manufacturer must request a review from the notified body; if the request is submitted between 12 and 6 months before expiry, a simplified review procedure may be available provided there have been no changes to the approved type or to the state of the art.

What happens if my machine changes Annex I category after a design modification?

The applicable conformity assessment procedure must be reassessed from scratch. If the modification adds, for example, a machine-learning-based safety component that did not previously exist, the machine becomes subject to Article 25.2 even if internal control under Article 25.4 or 25.3 had previously been sufficient.

Can the authorised representative handle the EU type-examination on my behalf?

Yes. Annex VII, point 10, allows the manufacturer's authorised representative to submit the application for EU type-examination and fulfil certain follow-up obligations (notifying modifications, requesting reviews and retaining documentation), provided these powers are expressly set out in the written mandate.

Do notified bodies have different fees for SMEs?

Article 25(5) expressly requires notified bodies to take into account the interests and specific needs of small and medium-sized enterprises when setting conformity assessment fees. In practice, this translates into tiered fees or instalment payment plans, although the Regulation does not set a mandatory minimum discount.

Can IgeraIndustria tell me which notified body I need?

IgeraIndustria identifies the applicable assessment procedure under Article 25 and Annex I based on your machine's technical file, and guides you on the type of notified body scope you need — for example, scope in machinery with machine-learning components — although the final choice and the contract with the notified body always rest with the manufacturer.

Last updated: July 2026 | Author: Jordi Bassols, Industrial Safety Engineer, COEIC registered | Sources: Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery, Article 25 and Annexes I, VI, VII, VIII, IX and X (OJEU L 165, 29.6.2023); Directive 2006/42/EC (in force until 19.1.2027). This article is for informational purposes only and does not constitute legal or engineering advice. IgeraIndustria — free trial.