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 manufacturer makes and records this route decision. An importer must verify before placement that the manufacturer completed the appropriate assessment, prepared Annex IV Part A documentation, affixed CE marking, and supplied the required documents. A distributor must act with due care and check the marking, documents, identification, and operator details before making the product available. These supply-chain checks do not transfer the manufacturer's design and assessment responsibility unless Article 17 or Article 18 applies.

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 record 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.

For the Article 25(2) and Article 25(3) notified-body procedures listed in Article 24(3), the CE marking is followed by the identification number of the notified body involved in the procedure. Partly completed machinery follows a different document set: an EU declaration of incorporation and assembly instructions, not CE marking as a complete machine.

Regulation (EU) 2023/1230 generally applies from 20 January 2027, when Directive 2006/42/EC is repealed. Article 52 prevents Member States from impeding the making available of products placed on the market in conformity with the Directive before that date. Some institutional and delegated provisions apply earlier under Article 54, but that does not move the general product-compliance date forward.

For a product first placed on the market or put into service from 20 January 2027, do not treat a Directive technical file as automatically sufficient. Remap Directive references, check Annex I Part A or Part B status, update technical documentation to Annex IV Part A, update the declaration to Annex V Part A, and apply the Regulation's conditions for digital instructions and declarations.