Context
Technical documents, risk assessments, operating instructions and conformity assessment are not new concepts. The requirements that apply to a specific product depend on the product, role and market.
Timing
The EU Machinery Regulation generally applies from 20 January 2027. Certain provisions apply earlier. The responsible company, with specialist advice, determines whether and which obligations apply to its product.
Digital documents
The Regulation contains provisions for digitally supplied information under certain conditions. The appropriate access method and documents for a specific product are matters for the relevant product and market assessment.
Substantial modification · Article 18
A substantial modification may mean that the modifying natural or legal person is treated as the manufacturer and assumes the corresponding obligations. Not every change meets the conditions. Roboterausweis does not make a legal classification.
Own brand and modification · Article 17
Importers or distributors may in certain circumstances be treated as manufacturers, for example where they market under their own name or trademark, or make a conformity-relevant modification. This must be assessed in the individual case.
How a product dossier can help
A product dossier can bring together records, product models, versions and documented machine states in a structured way. It does not replace an assessment of statutory completeness or conformity.
Official sources
Source status: 10 October 2026. General information; not a legal assessment of any individual case.
EUR-Lex · EU Machinery Regulation (opens in a new window)EUR-Lex · Legal basis (opens in a new window)