The machinery sector is the heart of the mechanical industry and one of the driving industrial pillars of the EU economy.
In January and February 2022, the European Parliament proposed several amendments to the proposal for a regulation on machinery products which was implemented in the version published on 31 March 2022. The new regulation aims – due to its general scope and its direct applicability – to ensure greater legal certainty and a high degree of harmonization of health and safety requirements in design , construction and trade of machinery throughout the EU.
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Machine regulation, the regulatory context
It must be remembered that the legislation expressed in the previous Machinery Directive (Directive 2006/42 / EC) was subject to revision from 2016 to ensure that new technologies – ie. the Internet of Things (IoT), artificial intelligence (AI)) and the new generation of autonomous robots – were properly considered. With that in mind, on April 21, 2021The European Commission has replaced the Machinery Directive with the proposed Regulation on Machinery Products (i.e. Machinery Regulation – MR) together with the publication of the proposed regulation on artificial intelligence (ie AI Regulation).
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It changed Machine Rules and that it will be finally approved by the end of April 2022aims to achieve an effective and timely overcoming of the essential constraints of Directive 2006/42 / EC in such a way as to adapt, on the one hand, the previous regulatory framework to the new technological and market context and, on the other hand, to implement simplification and digitization of administrative obligations.
Hardware control, what changes
The version of the Regulation of 31. March 2022 is characterized by having made several changes, and precisely with regard to.
- Distinctions between machines, related products (ie interchangeable equipment, safety components, chains, ropes and straps, detachable mechanical transmission devices) and partially finished machines.
- The nature of “Safety component”- It has been clarified that it can be physical, digital or mixed.
- Introduction of the definition of “security function” It aims to provide a safeguard measure to eliminate risks – where possible – or to reduce them.
- Definition of “significant change” – It is defined as the modification of a machine or related product – by physical or digital means – after the machine or related product has been marketed or put into service. The definition indicates that this change – not anticipated by the manufacturer – affects the specific original use and intended use of the machine or a related product to endanger its safety, create a new hazard or increase an existing risk. It follows that this modification requires “remedies” or additional protective devices, the control of which modifies the control system associated with the existing safety, or requires additional protective measures to guarantee the stability or resistance of the machine.
- Impact on the safety of a part of a whole in the light of a “significant change” It should be noted that the person making the change is only considered to be the manufacturer of the interested part of this set.
- Obligations in connection with the instructions in digital format – They involve:
- indicate on the machine, as well as in an accompanying document, how to access the digital instructions;
- indicate which version of the instructions corresponds to the model of the machine;
- prepare the instructions in a format that can be downloaded and saved by the end user on an electronic device that is available at all times, and remember that this format must be guaranteed, even if the machine’s instruction manual is built into the machine’s software itself;
- make the instructions available online for the entire life cycle of the machine or related product (ie for at least 10 years after the product has been placed on the market);
- provide the buyer with instructions in paper format upon request and free of charge.
- Conformity assessment procedure for partially completed machinery – It requires that:
- the partially completed machines are designed and built in accordance with the essential health and safety requirements;
- The procedures for ensuring the conformity of the semi-finished machine produced in series have been duly implemented taking into account the changes in terms of: production process, characteristics of the finished machine, harmonized standards or common specifications;
- the information provided makes it possible to identify the half-machine uniquely and the name and address of the manufacturer can be traced;
- the installation instructions and the EU declaration of incorporation – designed in such a way that they can be easily understood by the buyer, as determined by the Member State concerned – are provided in digital format and, if necessary, at the request of the buyer, free of charge in printed format.
- Obligations of importers and distributors of machinery or related products and sub-machinery.
- Common (technical) specifications – They may be adopted by the Commission in the absence of harmonized standards and clarifications of the role of stakeholders in the process of drafting them. In the case of publication of a harmonized standard – which covers the same aspects as a common specification – the harmonized standard replaces the common specification.
- EU declaration of incorporation referring to partially completed machinery – It must contain:
- certification of compliance with the applicable essential health and safety requirements;
- the translation into the language or languages required by the Member State in which the partially completed machinery is placed on the market;
- the notification if a partially completed machine is subject to several EU acts requiring an EU declaration of conformity and, where applicable, a declaration of conformity with those EU acts;
- the subdivision of the list of products in Annex I (formerly Annex IV to Directive 2006/42 / EC) into Parts A and Part B, including the two different conformity assessment procedures described in Article 21;
- partial amendment of some essential health and safety requirements in Annex III;
- the addition of “paragraph / letter C” respectively to:
- Appendix IV – ref. relevant technical documentation for substantially modified machinery;
- Appendix V – ref. EU declaration of conformity for substantially modified machinery
- the addition of “section / letter B” to Annex VI – ref. internal production control for partially finished machines;
- the addition of Annex IXa ref. conformity assessment procedure based on device verification;
- the assembly instructions for partially completed machinery in Annex X.
The importance of risk management
It follows that compliance with the Regulation implies that all actors involved dshould apply risk management to ensure greater compliance with the EU Regulation on machinery. It must be remembered that compliance with legislation should not be the primary driving force for the implementation of risk management.
Therefore, machine manufacturers should manage risks methodically during each step of the design and manufacturing process in a way that ensures risk reduction and better execution of projects. That is, it is about:
• carry out the preparation of a risk plan;
• analyze the risks;
• review and report on the results and risk mitigation measures;
• ensure a feedback loop of what is happening in the field.
MR places special emphasis on risk reduction “as far as possible”, ie. the risk management process must be started from the identification of activities and resources at the beginning of the project and as the project develops, until its production and application. market.
Therefore, companies need to understand the intent of the standard and how they can achieve value, as simply limiting the language of the standard does not translate the risk management system into the specific needs of the manufacturer; it is a matter of involving all actors / persons in the risk management process as a strategic lever to make the work easier and the product better.
Effects of the Regulation
We hope that new obligations under the Regulation will lead to a stricter range of machinery to be marketed, to the benefit of those who are able to pass all the control phases and who meet the many safety and efficiency requirements required by European rules, in favor of the end user.
It is important to remember that it is very necessary to check for any interaction or interference with other equipment or with other risks present in the system where the machine is installed. In fact, it is not enough to have safe machines: it is also necessary that the whole organization of work allows them to function properly and be used consciously by the employees, an awareness that can only be achieved with specific and adequate training.
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