MACHINERY REGULATION
Machinery Regulation (EU) 2023/1230: Requirements, Conformity and Safety of Machinery
Introduction to the Machinery Regulation (EU) 2023/1230
From the Machinery Directive to the Machinery Regulation – The Most Important Changes
The transition from the old Machinery Directive (Directive 2006/42/EC) to the new Machinery Regulation (EU) 2023/1230 marks a far-reaching milestone for European industry. While the previous directive always had to be transposed into national law by the individual Member States, the new regulation (often abbreviated as MVO) has direct legal validity that is uniform throughout the EU. This fundamental change brings about a noticeable harmonisation of the legal basis and eliminates country-specific scope for interpretation. For companies, this step means that existing processes for ensuring the safety of machinery and installations must be fundamentally reviewed and adapted to the new European legislation.
Objectives of the EU Machinery Regulation (MVO) for Safety, Protection and the Free Movement of Goods
The primary objectives of the new EU Machinery Regulation are to adapt the legal framework to advancing digitalisation and technological change in mechanical engineering. The MVO is intended to ensure that new technologies such as artificial intelligence, the Internet of Things (IoT) and autonomous systems do not compromise safety in the workplace. In addition, the Regulation strengthens the holistic protection of operators and third parties against accidents and technical risks. Another core objective is to increase legal certainty for every manufacturer by defining clear requirements for the legally compliant placing of modern products on the European single market, without slowing down the innovative strength of the industry.
Scope of the Regulation for Machinery, Products and Related Systems
The territorial and material scope of the Regulation extends across the entire European Economic Area. Every company that makes machinery, related products, interchangeable equipment or partly completed machinery available in the EU is directly affected by the new regulations. It is irrelevant whether the manufacturer is based inside or outside the European Union. The relevance of the legislation therefore concerns not only classic mechanical engineering, but the entire value chain, including importers and distributors who wish to establish products on the European market.
Scope and Affected Products
Which Machinery and Products Fall Under the Machinery Regulation
The scope of the Machinery Regulation covers a wide range of technical goods. In addition to classic complete installations and interlinked machinery, these include interchangeable equipment, safety components, lifting accessories, chains, ropes, webbing and removable mechanical transmission devices. Partly completed machinery, which only forms a functioning unit once assembled with other parts, is also a particular focus. The MVO specifies the technical requirements and makes clear that software that performs a safety function and is placed on the market separately can also fall under the Regulation as a safety component in its own right.
Distinction from Other EU Regulations and Directives
A precise distinction from other EU legislation is essential in order to avoid overlaps and double regulation. The Machinery Regulation is systematically distinguished from other directives, such as the Low Voltage Directive or the Radio Equipment Directive (RED). As soon as the hazards posed by a machine are covered more specifically by other harmonised Union legislation, the MVO does not apply with regard to these aspects. For the manufacturer, this means carrying out a detailed analysis to check exactly which European regulations apply cumulatively or exclusively to its specific products.
Exceptions and Special Use Cases According to the Annex
As under the old EC rules, the new Regulation also contains specific exceptions from the obligation to apply it. Excluded from the scope of the MVO are, among others, certain means of transport by road, air, rail or water, special equipment for nuclear power plants and devices intended primarily for military or police purposes. A special use case exists where machinery is designed purely for private use, for which in some cases different or less strict rules apply compared with the industrial sector. Nevertheless, the essential criteria for consumer protection must also be met in full here.
Obligations of Manufacturers and Economic Operators
Manufacturer Obligations Before Placing Machinery on the Market
Responsibilities of Importers, Distributors and Parties Placing Products on the Market
The Machinery Regulation places significantly more responsibility on importers and distributors than the previous legislation. An importer may only place products on the market in the EU that comply with the requirements of the MVO. It must verify in advance that the manufacturer has carried out the correct conformity assessment procedure and has properly drawn up the technical documentation. Distributors, in turn, must check with due care whether the machine bears the required CE marking and whether all documents are available in a language that can be easily understood by users.
Technical Documentation and Obligations to Provide Evidence
The obligations of economic operators to provide evidence have been tightened and clarified in the course of the new legislation. The technical documentation must contain all relevant details on the design, construction and operation of the machinery. The documents must clearly show which requirements of the Regulation have been applied and how the risks have been minimised. These documents must be kept available to the market surveillance authorities for at least ten years from the date of placing on the market. A significant innovation of the MVO is the general permission to provide these documents in digital form.
Health and Safety Requirements
Essential Safety Requirements According to Annex III
Annex III of the new Machinery Regulation sets out the essential health and safety requirements in detail. This annex forms the core of the MVO and defines the binding protection objectives for the design and construction of machinery. A manufacturer must comply with the requirements set out therein in order to guarantee the highest level of safety. The requirements range from mechanical strength and protection against ergonomic strain to specific requirements for control systems, in order to effectively rule out hazards throughout the entire life cycle of the machine.
Health Protection Requirements for Machinery and Installations
For certain product groups, the Regulation provides for extended and specific health protection requirements. This applies in particular to machinery used in the food sector, the pharmaceutical industry or cosmetics production, where hygiene aspects play a decisive role. Portable or hand-guided machinery is also subject to stricter criteria in order to minimise harmful exposure to vibration, noise or emissions. Protecting the health of operators is the focus of the regulatory provisions for these specialised health protection requirements.
Protection of Operators and Third Parties Through Design Measures
The best possible protection of persons against the hazards of technical installations must primarily be achieved through design measures. Only when an inherently safe design cannot completely eliminate the risk may technical protective measures such as guards, light barriers or interlocks be used. The Machinery Regulation requires that people are always optimally protected when interacting with the machine. Designers must anticipate incorrect behaviour or reasonably foreseeable misuse as early as the development phase in order to effectively prevent accidents for operators and third parties.
Risk Assessment and Safety Concept
Risk Assessment as the Basis for Machinery Conformity
Carrying out a systematic risk assessment is the fundamental basis for every conformity assessment procedure under the MVO. The manufacturer is legally obliged to carry out an iterative analysis in order to systematically identify all hazards associated with its machine. On the basis of this assessment, the necessary safety requirements must be defined and implemented in the design. Without a well-founded, documented risk assessment, no legally compliant declaration of conformity can be issued, as it represents the fundamental link between theory and practical safety.
Identification of Hazards and Protective Measures
The risk analysis process requires precise identification of all potential hazards that a machine may pose in all phases of its life. These include mechanical, electrical, thermal or noise-induced risks. However, the new Regulation significantly extends this classic approach: hazards arising from the integration of software, autonomous controls or the networking of systems must also be recorded. Only through this holistic analysis can tailored safety concepts be developed that meet current requirements for the protection of people and the environment.
Demonstration of Safety Throughout the Entire Life Cycle
Modern proof of safety must not be limited to the time of delivery. The Machinery Regulation implicitly requires that the safety of a technical installation is ensured throughout its entire life cycle, from assembly and commissioning through regular operation and maintenance to dismantling and disposal. Modifications or subsequent changes to a machine already in operation may make a new risk assessment necessary. The SAS hagmann team supports you in integrating this continuous verification process into your day-to-day operations completely and with legal certainty.
Digitalisation, Software and Corruption
Requirements for Digital Systems and Safety-Relevant Software
With the entry into force of the MVO, the legislator is responding directly to increasing digitalisation in industry. The requirements for digital systems have been tightened considerably. Software that performs safety-relevant tasks is now explicitly classified as a component in terms of safety. This means that programming, updates and digital control architectures are subject to the same strict validation processes as physical safety components. Manufacturers must ensure that software errors or unexpected system states can never lead to a hazard to people or machinery.
Protection Against Corruption and Unauthorised Changes
A completely new and critical aspect of the Machinery Regulation is the required protection against corruption. Machinery and its control systems must be designed in such a way that protection against intentional or unintentional corruption through unauthorised external access is ensured. Malicious interference or incorrect operation via digital interfaces must not override the safety functions of the machine. Proof of effective protection against manipulation and cyber risks is henceforth a mandatory element in meeting the Union’s essential safety requirements.
Cybersecurity Aspects in the Machinery Regulation
The link between operational safety and IT security is one of the central innovations of the current legislation. The MVO requires manufacturers to take cybersecurity aspects into account as early as the development process in accordance with the “secure by design” principle. Connecting a machine to the internet or internal networks must not provide a gateway for malware that manipulates the control system. Robust encryption, logging of access and clear authorisation concepts are minimum technical standards for documenting the required protection against cyber risks in a verifiable way.
Conformity Assessment Procedures Under the Machinery Regulation
Selecting the Right Conformity Assessment Procedure
The selection of the correct path for the conformity assessment procedure depends largely on the classification of the machine. The Regulation distinguishes between standard machinery and products with a potentially higher level of risk. As part of this risk assessment, all hazards posed by the machine must be identified. These explicitly include hazards from processed substances, released gases/vapours and operating materials used, such as hydraulic oils, coolants and lubricants, cleaning agents or other hazardous chemical substances. For ordinary machinery, the manufacturer can generally declare conformity on its own responsibility through internal production control, provided that it applies all harmonised standards in full. Precise evaluation of the appropriate procedure is of central importance in order to avoid delays in market access and to meet the legal requirements exactly.
Special Procedures for Machinery with Increased Risk
Stricter rules apply to product groups classified as high-risk in the Regulation (specifically in former Annex IV of the Directive, now Annex I of the MVO). These include, for example, certain woodworking machinery, presses or machinery with embedded AI that controls safety functions. In these cases, a mere self-declaration by the manufacturer is often not sufficient. An EU type-examination or a comprehensive quality assurance procedure involving a notified body must be carried out in order to complete the conformity assessment procedure in a legally valid manner.
Role of Harmonised Standards in Conformity Assessment
Harmonised standards play a key role in the practical implementation of the legal requirements. If a manufacturer applies a harmonised standard listed in the Official Journal of the European Union, the so-called presumption of conformity applies. It is then legally presumed that the machine meets those essential safety requirements that are covered by this specific standard. Although the application of these technical rules is voluntary in principle, in practice it is the safest and most efficient way to demonstrate conformity with the overarching Regulation beyond doubt.
Technical Documentation and Declaration of Conformity
Contents of the Technical Documentation
The new Machinery Regulation defines precisely which minimum contents the technical documentation must contain. In addition to design drawings, circuit diagrams and calculations, it must include complete documentation of the risk assessment. Evidence of tests carried out, software validations and the conformity of purchased components must also be an integral part. The experts at SAS hagmann provide structured support in preparing these extensive documents exactly in accordance with the requirements of the MVO, so that you are perfectly prepared for audits or market surveillance.
Preparation of the EU Declaration of Conformity
By issuing the declaration of conformity, the manufacturer confirms in a binding manner that its product meets all relevant requirements of the Regulation. This document must accompany every product when it is placed on the market, and from now on this can also be done with legal certainty in digital form via a QR code or download link directly on the machine. The declaration must clearly identify the manufacturer, the machine and its characteristics as well as all applied European directives, laws and harmonised standards. It forms the legal conclusion of the conformity process and permits the CE mark to be affixed.
Documentation Obligations for Manufacturers and Operators
Under the new legislation, strict archiving and provision obligations apply to both the original producer and the importer. The technical documentation and the declaration of conformity must be kept securely for a period of ten years after the last model has been placed on the market. If a significant change in the legal framework occurs during this period or the authorities request access, it must be possible to present the documents immediately and in digital form. This requires professional data and compliance management within the company.
Harmonisierte Normen und rechtliche Anforderungen
Significance of Standards for the Presumption of Conformity
In the European system of technical harmonisation, type A, type B and type C standards play a fundamental role. They translate the abstract legal protection objectives of the Regulation into specific, measurable technical criteria. By making use of the presumption of conformity of harmonised standards, manufacturers significantly reduce their liability risk in the event of damage. Since in an emergency the courts examine compliance with the current state of the art, following the standards listed in the Official Journal is the most effective protection against legal consequences for management.
Interplay Between the Regulation, Legal Requirements and Technical Standards
The structure of machinery safety is based on a closely interlinked interplay of different legal levels. At the top is the European Machinery Regulation, which sets the framework as directly applicable EU law. At national level, it is accompanied by country-specific laws, such as the Product Safety Act (ProdSG) in Germany, which regulate, among other things, the responsibilities of market surveillance. The harmonised standards form the technological basis. Only those who understand this complex interplay of European regulation, national laws and technical rules can place their products on the market with lasting legal certainty.
Publications in the Official Journal of the European Union
For a technical standard to obtain the status of a harmonised standard with presumption of conformity, its official listing in the Official Journal of the European Union is mandatory. Only with this publication is it formally recognised under the MVO. Since the list in the Official Journal is continuously updated, extended or replaced by new versions, companies must establish systematic standards monitoring. SAS hagmann takes over this monitoring for you so that you can react to revisions at an early stage and adapt your designs in good time.
Changes Compared with the Machinery Directive 2006/42/EC
Key Changes in the Machinery Regulation
The most serious change compared with the old Machinery Directive (Directive 2006/42/EC) concerns the legal form: direct applicability as a regulation eliminates national differences. In terms of content, the definitions of safety components have also been extended and market surveillance has been significantly strengthened. The obligations in the event that a substantial modification is made to a used machine, which can legally make the operator the manufacturer, have also been formulated much more clearly and restrictively in the new legal text in order to close safety gaps in the life cycle.
New Requirements for Safety, Digitalisation and Documentation
The MVO brings fundamental innovations for design practice. The safety requirements have been specifically extended to include cyber aspects, protection against manipulation and the functional safety of AI systems. In the area of documentation, the EU is taking a major step towards sustainability: instructions for use and declarations of conformity may now be provided digitally as standard. However, the customer has the right to request a free paper version from the manufacturer within one month of purchase, which requires logistical flexibility.
Impact on Manufacturers and Existing Machinery
For every manufacturer, the entry into force of the new rules means an urgent need for action. Existing templates for the declaration of conformity must be converted to the new Regulation (EU) 2023/1230; reference to the old directive is no longer permitted after the deadline. Since existing certificates and risk assessments must be checked for conformity with the new provisions, the internal adaptation process should be started at an early stage. Products that do not meet the new criteria may no longer be placed on the market in the EU after the transition period.
Implementation of the Machinery Regulation in Companies
Roadmap for the Legally Compliant Implementation of the Requirements
A successful and efficient transition to the new Machinery Regulation requires a structured approach. The roadmap recommended by SAS hagmann starts with a comprehensive inventory and a gap analysis of existing machinery concepts. In the next step, the risk assessments must be methodically adapted to the new cyber and software requirements of the MVO. This is followed by updating the technical documents and the digital instructions for use. The final step is training the design and compliance teams in order to firmly embed the new processes in the company in the long term.
Typical Challenges in Introducing the Machinery Regulation
In practice, companies face multi-layered challenges when applying the new Regulation. In particular, the required protection of digital interfaces against corruption and unauthorised access represents new technical territory for classic machine builders. The distinction as to when a modification to an existing machine constitutes a “substantial modification” and therefore entails a completely new conformity assessment procedure also frequently causes legal uncertainty in practice. Precise, technically sound risk management is essential to overcome these hurdles safely.
Compliance Management and Internal Processes
In order to meet the requirements of the new legislation on a lasting basis, the implementation of robust compliance management is essential. Internal processes, from the initial product idea through the purchasing of components to after-sales service, must be fully aligned with the requirements of the Machinery Regulation. Clear responsibilities and standardised checklists make it possible to effectively minimise the liability risk of management. As an experienced partner, SAS hagmann supports you in optimising your internal processes for complete CE compliance.
Testing and Verification Reference (Our Services)
Safety Testing and Conformity Assessments for Machinery
As a manufacturer-independent expert, SAS hagmann carries out chemical analyses on behalf of clients. Using the data collected in this way, the party placing the product on the market can evaluate risks that may arise from exposure to potentially hazardous substances or dangerous materials. This concerns the carry-over of process chemicals from manufacturing, auxiliary substances for the intended use of the product, cleaning agent residues and much more.
Support with Risk Assessments and Technical Documentation
Preparing a risk assessment that complies with standards requires in-depth expertise and detailed knowledge of the legal framework. SAS hagmann provides methodical support in identifying hazards arising from exposure to hazardous chemical substances and in carrying out the risk analysis in accordance with the stricter criteria of the MVO. We help you to systematically evaluate the new requirements for protection against corruption, the integration of software and the classic mechanical risks. Together, we develop effective safety concepts that maximise the protection of operators while maintaining the cost-effectiveness of your installations.
