Use this hub to decide whether an item is machinery, a or ; identify the manufacturer, authorised representative, importer, distributor or person making a ; and connect that role to the correct safety and market-access evidence.
Review this hub before design freeze, supplier integration, software release, classification, notified-body engagement, importer review, distributor listing, a , a change in the OJEU status or coverage of an applied standard, or an authority request. A person making a substantial modification is treated as the manufacturer for the affected product under Article 18, except for the Regulation's non-professional own-use case.
generally applies, and replaces , from 20 January 2027. Products placed on the market under the Directive before that date may continue to be made available, while products first placed on the market or put into service from that date must follow the Regulation. Classify scope first, then map safety requirements, the category, the conformity route and the records needed for the relevant market event.
Common starting points
Use these focused guides for the transition, product category, conformity assessment, or technical-file review under the EU Machinery Regulation. The complete guide library below covers the wider Regulation.
Use the Machinery for products first supplied or put into service before 20 January 2027. The Machinery governs products released from that date. Record the actual market event and keep the conformity file for the law that applied to it.
Compare the Directive and Regulationlists machinery categories that receive stricter conformity review. Part A always requires an independent route; Part B may use internal production control when harmonised standards cover every relevant requirement. Products outside Annex I normally use internal production control. contains the route choices.
Check the Annex I routeConformity assessment is the documented check that the product meets the Regulation before release. Connect the category and release date to the permitted route, technical documentation, EU declaration of conformity, and . Use a notified body only for a route that requires independent assessment.
Choose the conformity routecontains the essential health and safety requirements () for design and construction, such as guarding, controls, ergonomics, noise, and instructions. Before accepting the technical file, trace each applicable requirement to the risk assessment, design measure, standard, test, instruction, declaration, and conformity route.
Use the technical-file reviewTrack the Regulation text, transition from , category changes, harmonised-standard status, technical-documentation updates, digital instruction handling, EU declarations, and market-surveillance evidence for each product model.
New to the Regulation? Start by classifying the product and economic-operator role. If scope is already settled, jump to the route, implementation evidence, transition dates or a focused comparison.
Decide what the item is, whether an exclusion applies, who places it on the EU market and whether it is complete machinery, a related product, a safety component or partly completed machinery.
Map hazards to Annex III, determine the Annex I category and select the Article 25 route before design and conformity evidence are frozen.
Build the safety case, technical file, declarations, instructions and software records, then reopen the assessment when a physical or digital change could affect safety.
Separate fixed legal dates from internal release gates, preserve Directive-era evidence and understand post-market and Member State enforcement consequences.
Resolve common questions and keep machinery safety duties distinct from the AI Act and other EU product legislation that may apply to the same product.
This hub helps route Machinery Regulation work by product model, machinery category, economic operator, requirement set, classification, route, software evidence and EU market path. Assessment Autopilot can convert the release evidence into owned tasks; Research Copilot can support cited questions about scope, transition, technical documentation, digital instructions, notified-body routes and overlaps with other product law.
