Technical documentation under Annex IV Part A

Before placing on the market or putting into service, the manufacturer draws up the technical documentation and carries out the relevant conformity assessment procedure. The documentation must make it possible to assess the machine's conformity with the regulation — as far as necessary, it covers the design, construction and operation.

The fifteen elements, letter by letter

Annex IV Part A lists what the documentation contains at least:

1. a complete description of the machine and its intended use;
2. the risk assessment documents showing the procedure followed, with (i) the list of applicable essential requirements and (ii) the description of the protective measures and, where relevant, the residual risks;
3. the design and manufacturing drawings and diagrams of the machine, its components, subassemblies and circuits;
4. the descriptions and explanations needed to understand those drawings and the operation;
5. the references of the harmonised standards (Art. 20(1)) or common specifications (Art. 20(3)); where partially applied, the applied parts are indicated;
6. where standards or specifications were not applied or only partly: the description of the other technical specifications used to meet the requirements;
7. the reports and results of the design calculations, tests, inspections and examinations;
8. the description of the means by which the manufacturer ensures, during manufacture, conformity with the design specifications;
9. a copy of the instructions for use and of the information referred to in Annex III point 1.7.4;
10. where applicable, the EU declaration of incorporation (Annex V Part B) and the assembly instructions of the incorporated partly completed machinery;
11. where applicable, copies of the EU declaration of conformity for the machine and for incorporated products covered by other Union harmonisation legislation;
12. for series production, the list of the internal measures taken;
13. the source code or programming logic of the safety software — on the reasoned request of a competent national authority and only to the extent needed to check the Annex III requirements;
14. for sensor-based, remotely controlled or autonomous machines whose safety-relevant operation is controlled by sensor data: the description of the features, capabilities and limits of the system, of the data and of the development, testing and validation procedures;
15. the results of the tests on components and accessories needed to determine whether the machine can be safely assembled and put into service.