The technical documentation provides information on the design, the manufacture and the functioning of a product, and must include all the data necessary to demonstrate that the product meets the applicable requirements.
Machinery manufacturers should carry out a risk analysis of their machines and ensure that they meet specific standards before introducing them to the EU market.
Manufacturers must follow certain rules to place a product on the market.
Therefore, the manufacturer must:
- Prepare technical documentation before placing the product on the market
- Make sure to make the technical documentation available to market surveillance authorities
- Keep the technical documentation for 10 years from the date the product is placed on the market (unless otherwise expressly stated).
The technical documentation is necessary to demonstrate that the product meets the essential requirements and therefore justifies and supports the EU declaration of conformity.
This documentation is necessary to place the CE marking on the product.
In this article you will find a description of all the technical documentation needed to comply with the new European Parliament and Council Regulation on machinery PE-6-2023-INIT).
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What technical documentation is required for machinery and related products?
The technical documentation shall specify the means used by the manufacturer to comply with the requirements established to protect essential health and safety.
The technical documentation shall include at least the following elements:
Full description of the machine or related product and its intended use;
Documentation on the risk assessment demonstrating the procedure carried out, including:
List of essential health and safety requirements applicable to machinery or related product;
Description of the protective measures applied to meet each of the essential health and safety requirements and, where appropriate, the indication of residual risks associated with the machine or related product
Drawings and diagrams for the design and manufacture of the machinery or related product and its components, sub-assemblies and circuits;
Descriptions and explanations necessary for the understanding of the plans and systems mentioned in point (3) and the operation of the machine;
Depending on whether harmonised standards are applied or not, only one of the following points (5 or 6) is required.
Harmonised standards are those which have been adopted by a European standardisation body, on the basis of a request submitted by the Commission and published in the Official Journal of the European Union.
The list of harmonised standards referenced to each of the Union Regulations and Directives can be found on the following page: No
Harmonised standards are those which have been adopted by a European standardisation body, on the basis of a request submitted by the Commission and published in the Official Journal of the European Union. The list of harmonised standards referenced to each of the Union Regulations and Directives can be found on the following page: Harmonised Internal Market Standards, Industry, Entrepreneurship and SMEs (europa.eu).
References of harmonised standards, where the product conforms to harmonised standards or parts thereof, or common technical specifications adopted by the Commission and applied for the design and manufacture of the machine or related product. In case of partial application of harmonised standards or common specifications, the documentation shall specify the parts that have been applied.
Where harmonised standards or common technical specifications have not been applied or have been only partially applied, descriptions of other technical specifications applied to meet each of the essential health and safety requirements applicable shall be included in the technical documentation;
reports and/or results of design calculations, tests, inspections and examinations carried out to verify the conformity of the machinery or product related to the applicable essential health and safety requirements;
Description of the means used by the manufacturer during the production of the machine or related product to ensure the conformity of the machine produced with the design specifications
Harmonised standards are those which have been adopted by a European standardisation body, on the basis of a request submitted by the Commission and published in the Official Journal of the European Union. The list of harmonised standards referenced to each of the Union Regulations and Directives can be found on the following page:Harmonised Internal Market Standards, Industry, Entrepreneurship and SMEs (europa.eu).
References of harmonised standards, where the product conforms to harmonised standards or parts thereof, or common technical specifications adopted by the Commission and applied for the design and manufacture of the machine or related product. In case of partial application of harmonised standards or common specifications, the documentation shall specify the parts that have been applied.
Where harmonised standards or common technical specifications have not been applied or have been only partially applied, descriptions of other technical specifications applied to meet each of the essential health and safety requirements applicable shall be included in the technical documentation;
Reports and/or results of design calculations, tests, inspections and examinations carried out to verify the conformity of the machinery or product related to the applicable essential health and safety requirements;
Description of the means used by the manufacturer during the production of the machine or related product to ensure the conformity of the machine produced with the design specifications
Copy of instructions for use and instructions for maintenance.
Basic principles for writing instructions for use: instructions for use should explain how to use machinery or product correctly, and also take into account possible incorrect forms of use. If the machinery or product is intended to be used by non-professionals, the instructions should be easy to understand and adapted to the educational level and general skills of those persons.
When necessary, the EU declaration of incorporation of the partially finished machine, and the assembly instructions
Where necessary, copies of the EU declarations of conformity of the machinery or related products, as well as of any product covered by other Union harmonisation legislation incorporated in the machine or related product;
For machines or related products produced in series, the internal measures to be applied to ensure that the machine or related product remains compliant with this Regulation;
The source code or programming logic of the safety-related software to demonstrate the conformity of the machine or product related to this Regulation at the reasoned request of a competent national authority; where necessary to enable those authorities to verify compliance with the essential health and safety requirements.
in the case of sensors-powered, remotely operated or self-contained machines or related products, if safety-related operations are controlled by sensor data, a description, where applicable, of the general characteristics, capabilities and limitations of the system, data processes, development, testing and validation used;
the results of the investigations and tests carried out by the manufacturer on the components, accessories or the machine or related products to determine whether, by design or construction, it can be safely assembled and put into service.
How should information be presented?
All relevant documentation, such as instructions for use, even if it contains precise and understandable information, should be written in a easily understandable form and be available in a language that users can easily understand, as determined by the Member State concerned, takes account of technological developments and changes in user behaviour and is as up to date as possible.
Where products falling within the scope of this Regulation are placed on the market in packages containing several units, instructions and information shall accompany the smallest commercial unit available.
Instructions and other relevant documentation can be provided in a digital printable format.
However, the manufacturer must ensure that distributors can provide, at the request of the user at the time of purchase, instructions for use in paper format free of charge. The manufacturer should also consider providing contact details where the user can request instructions to be mailed.
