The machine manufacturer must prepare technical documentation for its products.
The technical documentation required for a machine or similar product, in accordance with Regulation 2023/1230, is set out in Annex IV. Its purpose is to set out the measures taken to ensure compliance with the EHSR and the requirements, and it contains, in summary form, the following information:
• A description of the machinery and its intended use
• A list of EHSR, a description of safety measures and residual risks
• Design and manufacturing drawings and diagrams with the necessary explanations
• Information on the standards or general specifications used, or an indication of which of these have been applied
• A description of other specifications applied
• Calculations, tests, inspections and reports relating to compliance with EHSR
• Operating instructions and information
• For partly completed machinery — the EU Declaration of Conformity and assembly instructions
• Other EU declarations of conformity applied
• Confirmation of conformity of series production
• Upon request by the competent authority — the source code or programming logic of safety-related software
• Information on sensors, where these are used for safety purposes in remotely controlled or autonomous machinery
• Test results relating to safe assembly or commissioning
Machinery and equipment must be designed and manufactured in such a way as to ensure safe operation for the user by eliminating or minimising potential risks under the intended conditions.
The manufacturer must also take into account reasonably foreseeable cases of misuse. If risks cannot be sufficiently reduced by other means, they may be mitigated by means of a safety function. As a new requirement, safety functions must be implemented in such a way that, where necessary, the user can verify the operability of the safety function; furthermore, all necessary equipment and documentation must be provided to ensure safe operation, maintenance and adjustment.