Machine regulation
The instruction manual: what changes in the new Machinery Regulation
As is now well known, the new Machinery Regulations will bring major changes to the instruction manual, not only in content but also in form.
In this article we address the key changes brought by the Machinery Regulations and what will be the necessary information that the instruction manual must contain, as required by article 1.7.4.2.
We will also see the guidelines that will enable us to properly design the instruction manual for our products.
truzioni per i nostri prodotti.
The key changes in the new Machinery Regulations
The new Regulation and the instruction manual
The new Machinery Regulation defines the operating instructions as the set of information needed by the user; they describe the intended use for the machine, the precautions to be taken, its installation and maintenance as well as all that is related to safety information.
“Instructions and other relevant documentation may be provided in a digital printable
format. However, the manufacturer should ensure that distributors can provide, at the
request of the user at the time of the purchase, the instructions for use in a paper format
free of charge. The manufacturer should also consider providing the contact details where the user can request the instructions to be dispatched by mail.”
Recital 40 introduces for the first time the possibility of providing instructions in “digital format.”
If the manual is supplied in digital format, it must always be possible to print it out and supply it in hard copy at the Customer’s request, without any extra price.
The request for printed instructions can be made either when buying and selling the machine or at any other time; therefore, the Customer must have an email address to which the request can be forwarded.
Specific requirements for the digital instruction manual
Item 7 of Article 10 regarding the obligations of economic operators lists other requirements for those who choose to provide the instruction manual in digital form:
(a) It must be specified on the product or its packaging how the instruction manual can be accessed;
(b) The instruction manual must be stored in such a way that it is always downloadable and printable, even in case of machine breakdown;
(c) The instruction manual must always be accessible to the operator throughout the life of the machine, and always for at least 10 years after the last product to which it relates was placed on the market.
The solution that WAVES ENGINEERING considers most efficient to be compliant with the requirements of the new Machinery Regulation is to print a QR code on the CE marking plate of the machine.
The instruction manual can be be uploaded to a server that is always accessible and possibly never only within the machine software or to the operation of a device such as a tablet or e-reader.
The instruction manual can be uploaded within servers controlled by the manufacturer and kept for the lifetime of the machine.
When the machine is used by non-professional operators (or use by non-professional personnel is reasonably foreseeable), at least the part related to safety instructions of the product must always be provided in hard copy.
The instruction manual shall be provided in a language that is easily understood by the user; this language shall be defined by the member state in which the machine is sold.
How to write correctly the instruction manual
The language used within the instruction manual must be clear, understandable, all information must be recognizable and readable.
It is very useful to read and apply the harmonized standard EN ISO 20607:2019, which provides a presumption of conformity to 1.7.4.2 requirement, covering the contents of the instruction manual in both the current Machinery Directive and the new Machinery Regulation.
For more information on how to write the instruction manual and for advice on how to apply the standard and be compliant with the Machinery Directive and the New Regulations please contact us!.
The contents of the instruction manual in the new Machinery Regulation
The new Machinery Regulation lists in requirement 1.7.4.2 the minimum contents of a machine’s instruction manual. Below we will look at all the points:
(a) The manufacturer’s data, company name, full address and data on its legal representative;
(b) The designation of the machine, and the main data. The serial number of the product can be omitted if the manual refers to one model or family of machines.
(c) The original EU Declaration of Conformity, or a link address or QR code by which the EU Declaration of Conformity can be accessed. Unlike the current Machinery Directive, it is no longer permitted to include a copy of the document but the original product declaration must always be accessible;
(d) The general description of the machine;
(e) The drawings, diagrams relating to the use, maintenance and repair of the machine as well as the descriptions necessary to understand them;
(f) The description of the operator’s station;
(g) The description of the intended use;
(h) The description of misuse based on the manufacturer’s experience;
(i) All instructions for assembly, protection by guards, installation, and connection of the machine to power sources, as well as the drawings and diagrams necessary to enable the operator to perform these operations safely.
(j) The necessary instructions for installing and assembling the machine to reduce noise and vibration levels;
(k) The instructions for commissioning, operating the machine, and training operators;
(l) The information regarding the inherent safety of the machine, the safety measures taken and the additional measures required (e.g. PPE or specific safety procedures). When present, all residual hazards of the machine must be described in detail.
(m) All safety measures to be taken by the operator, as well as the required personal protective equipment, must be described;
- n) The characteristics of the tools that can be mounted on the machine must be given;
- o) It is necessary to describe the conditions that guarantee the stability of the machine at all stages of its life: transport, installation, operation, maintenance, disassembly, considering also the foreseeable cases of failure.
- p) Instructions for safely conducting the lifting and transport operations of the machine such as the weight and positioning of lifting points of the machine and components that must be transported independently must be given;
- q) A description of the methods that can be used to reset the machine in case of lockout or failure and instructions for conducting these operations safely;
(r) All operations necessary in order to maintain the machine in optimum condition must be specified, as well as a description of the operations and their frequencies;
(s) Instructions for safely conducting maintenance operations;
(t) The specifications of components and spare parts.
u) The noise emission levels of the machine must be declared (see also the article on noise emission of machines to better understand this point);
ua) The necessary instructions for rescuing people must be provided;
(v) When the machines present a hazard related to non-ionizing radiation emissions, particularly to people wearing active or inactive implantable medical devices, all necessary information must be provided;
(w) When the machine presents hazards related to the emission of hazardous substances, instructions for the collection, filtration and discharge of such substances must be provided;
If the discharge devices are not supplied with the machine, the discharge flow of such substances, the concentration of hazardous substances and the characteristics of the filtration system as well as how to keep the filtration system efficient over time must also be provided.
Other key points for the instruction manual
Part 1 of the requirements specifies the general requirements that all machine instruction manuals must follow while the parts related to specific machine categories (e.g., Part 2 for food and pharmaceutical machines) contain additional requirements that must be followed.
If a harmonized standard is applied, it is always mandatory to check the additional requirements for the instruction manual that it includes, according to the new Machinery Regulation.
Conclusions
The new Machinery Regulation introduces many new features for the instruction manual of our products. The Regulation will enter into force on 20.01.2027, by that date we will have to be ready and updated.
It is therefore good to start now and understand what are the presentation methods we want to adopt and what are the contents we need to add.
What can we do for you?
Waves Engineering has already started the process of adapting our documents to comply with the new Machinery Regulation.
Our technical staff can help you produce instruction manuals for your products in a very short time for both the current machinery Directive and the new Regulation.
If you want to learn more, need additional information, or simply want to get to know us, visit our contact section.
WAVES Engineering S.r.l.