EU Machinery Regulation Conformity Assessment and CE

Article 25 starts with the category of machinery or related product. If the product is not listed in Annex I, the default route is internal production control, module A, in Annex VI.

Annex I Part A is different: the manufacturer must use one of the notified-body routes listed in Article 25(2). Those routes are EU type-examination followed by conformity to type, full quality assurance, or unit verification.

Annex I Part B sits between those positions. Internal production control is available only when the product is designed and constructed according to harmonised standards or common specifications that are specific to that category and cover all relevant essential health and safety requirements. If that condition is not met, the manufacturer must use one of the notified-body routes in Article 25(3).

The technical documentation in Annex IV Part A has to explain how the manufacturer ensured conformity with the applicable essential health and safety requirements in Annex III. It is not just a certificate folder.

For machinery and related products, the file should identify the product and intended use, contain the risk assessment, list applicable essential health and safety requirements, describe protective measures and residual risks, include drawings and explanations, identify harmonised standards or common specifications used, and keep test, inspection, and examination results.

Where relevant, Annex IV also calls for instructions for use, declarations or assembly instructions for incorporated partly completed machinery, declarations for other Union harmonisation legislation, production controls for series manufacture, and safety-related software source code or programming logic when a competent authority makes a reasoned request.

After the relevant conformity assessment has demonstrated compliance with Annex III, Article 10 requires the manufacturer to draw up the EU declaration of conformity and affix CE marking. The CE marking must be visible, legible, indelible, and affixed before the machinery or related product is placed on the market or put into service.

The declaration should follow Annex V Part A. It identifies the machinery or related product, manufacturer, object of the declaration, applicable Union harmonisation legislation, applied harmonised standards or common specifications, and the notified-body route where one was used.

If a notified body is involved under Article 25, the CE marking is followed by the notified body's identification number for the listed procedures. Partly completed machinery follows a different document set: EU declaration of incorporation and assembly instructions, not CE marking as a complete machine.

Regulation (EU) 2023/1230 replaces the Machinery Directive framework, so a Directive 2006/42/EC technical file should not be treated as automatically sufficient for a Regulation file. The regulation keeps familiar elements such as risk assessment, technical documentation, declarations, and CE marking, but changes the legal structure and the Annex I route logic.

The practical transition check is document-level: remap old Directive references to the Regulation, check whether the product falls in Annex I Part A or Part B, update the technical documentation to Annex IV Part A, update declaration content to Annex V Part A, and confirm whether instructions or declarations are being provided digitally under the Regulation conditions.