Machinery Regulation
The technical file of machinery in the new Regulation
The technical file for a machine is the set of all the documentation required for the design that attests that the machine meets the applicable health and safety requirements through drawings, diagrams, written descriptions and test reports.
The new Machinery Regulations will pose some major challenges to manufacturers, one of the main ones being the preparation of the technical file, which will require many new documents and information.
Like all challenges, it is always good to be prepared early on to understand how best to deal with them; in this article we discuss the technical file under the new Machinery Regulation, comparing it with what is required under the current Directive.
The general requirements of the new Regulation
The publication of the new Regulations is now imminent: there is talk of the first half of 2023, likely in April or May. The current available text is in English and will be quoted within this article as is in order not to run into problems with interpretation of the terms used.
The technical file for machinery is a document that must accompany the product and undergoes many changes within the new Regulation.
All manufacturers will have to adapt the current technical file of their products within three and a half years after the new Regulation comes into force (20 days after publication in the Official Journal of the European Union).
The minimum contents of the technical file are described in Annex VII of the current Machinery Directive while in the new Regulation they will be moved to Annex IV.
So let’s see together, point by point, the differences between the two texts.
General information
Let’s start by pointing out that the new Regulation specifies that the technical dossier must be prepared both for the machine and the products related to it, such as interchangeable equipment; in fact, they too will have to comply with all applicable health and safety requirements (ESHR).
(a) a general description of the machinery
(a) a complete description of the machinery or related product and of its intended use
The first point stipulates that the technical dossier should start with a “detailed” description of the product; previously it was referred to as a general description.
The description of the machine must highlight all its technical specifications that characterize it at the pre-design stage. It is no longer a simple description but a true technical specification in which the intended use is also indicated.
Usually, it is possible to define reasonably foreseeable misuses, already at this level. This content will help in the drafting of the operating manual.
(b) the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery
(d) design and manufacturing drawings and schemes of the machinery or related product and of its components, sub-assemblies and circuits
In the second point, there are no major changes: it is still necessary to attach to the technical dossier all the drawings and diagrams that are used to describe the product.
The risk analysis and compliance with standards
(c) full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements, the documentation on risk assessment demonstrating the procedure followed, including:
(i) a list of the essential health and safety requirements which apply to the machinery;
(ii) the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery
(b) the documentation on risk assessment demonstrating the procedure carried out,
including:
(i) a list of the essential health and safety requirements that are applicable to the machinery or related product;
(ii) the description of the protective measures implemented to meet each applicable essential health and safety requirement and, when appropriate, the indication of
the residual risks associated with the machinery or related product;
The machine’s hazard analysis will remain the heart of the technical file. A document in which the manufacturer describes the hazards present in the product and the measures by which he has assessed and lowered the risks.
An assessment of the essential health and safety requirements (EHSR) must also always be provided.
This point is not changed, but it will be necessary to conduct an analysis adapted to the new requirements in the regulation.
(e) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (d) and of the operation of the machinery or related product
Item (e) introduces a new feature.
It will be necessary to provide a clear explanation on how to interpret machine drawings and schematics.
Using universal drawing methodologies (e.g., for electrical diagrams) will make it very easy to respond to this new point.
(d) the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards.
(f) the references of the harmonised standards referred to in Article 17(1) or common
specifications adopted by the Commission in accordance with Article 17(3) that have been
applied for the design and manufacture of the machinery or related product. In the event of partial application of harmonised standards or common specifications, the documentation shall specify the parts, which have been applied;
Item (f) requires the standards used for its design to be indicated. Unlike the current Directive, common specifications (technical specifications provided directly by the European Commission on particular issues) are introduced and are equated with harmonized standards.
It will also be necessary to indicate which parts of the standards were used and for which aspects of the design.
(g) where harmonised standards or common specifications have not been applied or have been
only partially applied, descriptions of the other technical specifications that have been applied in order to meet each applicable essential health and safety requirements;
If solutions other than those contained in harmonized standards or common specifications are used to meet the requirements, it is necessary for the manufacturer to indicate which technical solutions were applied in order to specifically meet the essential health and safety requirements.
Testing and verification of machines
(e) any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative
(h) reports and/or results of the design calculations, tests, inspections and examinations
carried out to verify the conformity of the machinery or related product with the
applicable essential health and safety requirements;
Item (h) requires all reports of tests, calculations and inspections conducted by the manufacturer or a third party in order to prove compliance with the specific requirements to be provided.
It is important that it is clear to which essential health and safety requirement each test or inspection conducted refers.
(j) a description of the means used by the manufacturer during the production of the machinery or related product to ensure the conformity of the machinery or related product produced with the design specifications;
Item (j) is new.
The manufacturer will have to describe what methods he uses to ensure that his product meets the technical specifications provided within the technical file.
ISO 9001-certified companies will be able to prove this point very easily, the others will have to draw up a special document demonstrating the quality of production.
Here it will also be necessary to distinguish between mass production of machines and project production.
The instruction manual
f) a copy of the instructions for the machinery
(k) a copy of the manufacturer’s instructions for use and the information set out in section 1.7.4 of Annex III;
Here it is required to attach to the technical dossier, in addition to the instruction manual, all the documents required by requirement 1.7.4 of the regulation such as the EU Declaration of Conformity. Please keep in mind that the machine’s instruction manual contains several changes from what is required by the current Machinery Directive (see also article dedicated to the instruction manual for the new regulation).
Integrated machinery, partially-completed machinery and components
g) where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly Instructions for such machinery
(l) where appropriate, the declaration of incorporation for partly completed machinery set out in Annex V and the relevant assembly instructions for such machinery
As it is required in the current Directive, it will be necessary to integrate within the technical dossier the declaration of incorporation for partly completed machineries that were integrated within the product.
h) where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery
(la) where appropriate, copies of the EU declaration of conformity of machinery or related
products as well as any product covered by other EU harmonisation legislations
incorporated into the machinery or related product;
All declarations of conformity of machines or products integrated into the product must also be attached.
The safety software
(n) the source code or programming logic of the safety related software to demonstrate the conformity of the machinery or related product with this Regulation further to a reasoned
request from a competent national authority provided that is necessary in order for those
authorities to be able to check compliance with the essential health and safety requirements set out in Annex III;
Item (h) is a new element.
The source code of the machine’s safety software is required to demonstrate the machine’s compliance with the requirements of the Regulations in case of inspection by the authorities.
(o) for sensor-fed, remotely-driven, or autonomous machinery or related product, if the safety related operations are controlled by sensor data, a description, where appropriate, of the general characteristics, capabilities and limitations of the system, data, development, testing and validation processes used
Item (o) is new.
For machines with autonomous operation, controlled by sensors, it is necessary to provide general information, describe the limitations and the validation process of the system.
Tests and research
(p) the results of research and tests on components, fittings or the machinery or related product carried out by the manufacturer to determine whether by its design or construction it is capable of being assembled and put into service safely.
Item (p) is new.
The result of tests on machine-related components and products that have been carried out to determine its safety must be provided.
Usually the tests that are carried out on the machine are at least the following:
• Test for noise assessment – requirements 1.5.8 and 1.7.4.2 letter u;
• Test for electromagnetic compatibility – requirements 1.5.10 and 1.5.11;
• Electrical testing – requirement 1.5.1.
The manufacturer may perform as many tests on the product as deemed necessary. Even if they are not required by a standard, however, it is important that the test reports are collected within the technical dossier.
i) a copy of the EC declaration of conformity product carried out by the manufacturer to determine whether by its design or construction it is capable of being assembled and put into service safely.
Point (i) of the current Directive is included within point (k) of the new regulation.
l) for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive. The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.
(m) for machinery or related products produced in series, the internal measures that will be implemented to ensure that the machinery or related product remains in conformity with this Regulation;
For serial produced machines, it is necessary to describe the internal measures that ensure the quality of production against the Machinery Regulations.
The regulation then goes on to list under B the requirements for the relevant technical documentation of partly completed machinery.
The technical dossier or relevant technical documentation must be kept by the manufacturer for 10 years after the product is placed on the market.
Conclusion
In the new Regulation the technical file for machinery will contain much additional information than what is required by the current text of the directive.
The Machinery Regulation will be published in the Official Journal of the European Union probably in the first half of 2023, will become valid 20 days after its publication, and will have to be applied for the duration of three and a half years after its entry into force. The current text is probably 90% final so it is a good idea to study the new features now, stay up-to-date and correctly implement the new changes in our documentation.
How can we help you?
WAVES ENGINEERING is by your side in the transition to the new Machinery Regulations.
We are already adjusting all documents to the new settings so that we can best help you right away.
If you would like to know what we can do for you, want to learn more about these topics, or simply want to get to know us, please contact us by visiting the dedicated section!
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