Machinery Regulation FAQ Article 25 Modules

Article 25 does not ask teams to choose a module by preference. It first separates machinery and related products into Annex I Part A, Annex I Part B, or not listed in Annex I, then limits the available conformity assessment procedures for that route.

For Annex I Part A, the available procedures are EU type-examination under Module B followed by conformity to type based on internal production control under Module C, full quality assurance under Module H, or unit verification under Module G. Module A alone is not available for Part A categories.

For Annex I Part B, Module A is available only if the manufacturer designs and constructs the product in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements. If that condition is not met, the manufacturer must use Module B plus C, Module H, or Module G.

Annex I Part A contains the categories that trigger Article 25(2), including removable mechanical transmission devices and their guards, vehicle servicing lifts, portable cartridge-operated fixing and other impact machinery, certain machine-learning safety components, and machinery with embedded self-evolving machine-learning systems ensuring safety functions in respect of those systems.

Annex I Part B contains categories that trigger Article 25(3). The practical difference is that Part B can still use Module A when the relevant harmonised standards or common specifications fully cover the applicable EHSRs for the category. If the product departs from that coverage, uses only partial coverage, or relies on other technical specifications for relevant requirements, the Article 25 route shifts to a notified-body route.

In Module B, the notified body examines the technical design, reviews the technical documentation, examines a representative specimen, checks use of harmonised standards or common specifications, and issues or refuses an EU type-examination certificate. Module C is then the manufacturer's production-control step against that approved type.

In Module H, the notified body assesses and approves the manufacturer's quality system, monitors it through surveillance, and its identification number accompanies the CE marking under that module. In Module G, the notified body carries out or has carried out examinations and tests for the individual unit and issues a certificate for those examinations and tests.

Use the notified-body database to confirm that the body is notified for the relevant machinery legislation and scope. A voluntary certificate from a body acting outside its notified scope is not a substitute for the Article 25 procedure.

The technical documentation should make the Article 25 route auditable. It should show the intended use, applicable EHSRs, risk assessment, protective measures, residual risks where relevant, drawings and schemes, standards or common specifications applied, other technical specifications used where standards are not fully applied, and reports or results from calculations, tests, inspections, and examinations.

The evidence set should also connect the selected module to the declaration and marking package. For Module A, that means the technical documentation, production-control evidence, CE marking, and EU declaration of conformity. For notified-body routes, add the relevant certificates, approvals, reports, and notified-body identification-number evidence required by the chosen module.