EU Machinery Regulation Annex I conformity route

Start with the product configuration that will be placed on the EU market or put into service. Record whether it is machinery, a related product, a safety component, or partly completed machinery, then check whether any specific Union harmonisation law covers the same risks more specifically. If it does, stop the Annex I route check for those risks and use that more specific Union legislation to the extent that it applies.

Confirm the release date before applying this workflow. The Regulation generally applies from 20 January 2027; Article 52 preserves the making available of products placed on the market in conformity with Directive 2006/42/EC before that date.

For a Regulation release, Article 25(2) applies to Annex I Part A, Article 25(3) applies to Part B, and Article 25(4) points to internal production control under Module A when the product is not listed.

After the Annex I classification is documented, select only the route that Article 25 permits for that category. Treat the selected route as a release gate: the technical documentation, declaration, CE marking, and any notified-body certificate must align with the same route.

For Annex I Part A, self-assessment under Module A is not one of the listed options. For Annex I Part B, Module A is available only when the machinery or related product is designed and constructed according to harmonised standards or common specifications that are specific to the category and cover all relevant essential health and safety requirements.

The route decision should point directly to Annex IV Part A technical documentation for machinery and related products. The record should make clear which essential health and safety requirements apply, which protective measures meet them, which standards or common specifications were used, and which tests, inspections, calculations, or examinations verify conformity.

When software, sensor-fed operation, remote driving, autonomy, or safety-related programming is relevant, include the documentation Annex IV calls out for source code or programming logic, and for the system characteristics, capabilities, limitations, data, development, testing, and validation processes.