The new EU Machinery Regulation is intended to finally provide more clarity on the subject of machinery safety within the EU. The regulation replaces Directive 2006/42/EC, which has been in force since 2009. We explain what will change with its publication.
FROM THE DIRECTIVE TO THE REGULATION
The EU Machinery Directive is the legal basis for the free trade of machinery. This is because it uniformly regulates the safety requirements for the manufacture, operation and placing on the market of machinery.
The aim was to create a set of rules for a single European market in which the same safety standards apply, thus making products freely marketable. In addition to the entire EU economic area, the directive also applied to Switzerland, Liechtenstein, Turkey, Norway and Iceland. Furthermore, many non-European countries have also aligned themselves with Directive 2006/42/EC.
Directive leaves room for interpretation
There are various reasons why the Machinery Directive will be replaced by the EU Machinery Regulation (MDR) from 2023 (with a transitional period). One of these is the greater binding nature of transposing the requirements into national law.
Different interpretations of the directive could cause legal uncertainties, even in detail, if manufacturers wanted to export their plant or machinery to another EU member state.
In order to minimize such obstacles and the associated administrative burden in future, a regulation is now being published instead of the directive: this has direct legal force and does not have to be transposed into national law first.
State-of-the-art regulations
With the “Regulation of the European Parliament and of the Council on machinery products”, the regulations are once again in line with the current state of the art. The directive has been continuously updated with harmonized standards. However, the new regulation makes sense due to the rapidly advancing technological developments.
This is particularly true in light of the growing importance of artificial intelligence and cyber security. The new regulation is also intended to ensure legal clarity across the EU in these areas.
In addition, the regulation was used to harmonize existing legislation (e.g. “Blue Guide”). This also reflects the desire to put the requirements for machinery safety in the EU as a whole on a modern footing.
After the transition period, the provisions of the ordinances will be binding from the end of 2026.
EU MACHINERY REGULATION APPLIES TO THE ENTIRE SUPPLY CHAIN
One of the most important changes under the MVO is the extension of the scope of validity. This means that the regulation affects all market participants.
This means that not only manufacturers and operators of machinery must know and comply with the applicable requirements for machinery safety, but also (online) dealers of machinery and used machinery, importers and authorized representatives. The extension of the regulations to the entire supply chain is intended to provide additional safety.
THIS IS NEW IN THE EU MACHINERY REGULATION
The MVO also addresses new topics (such as cyber security, as mentioned above), introduces new terms or clarifies certain issues in more detail. We explain the most important changes.
New term: “substantial modification”
The newly introduced term “substantial modification” is closely linked to the required conformity assessment procedure for CE marking. This refers to physical or digital changes to a machine product that
- have arisen after the product has been placed on the market or put into service,
- were not foreseeable for the manufacturer and
- which may lead to deviations of the product from the essential health and safety requirements.
A significant modification may therefore require a new procedure for labeling. For this reason, the MVO clarifies the conditions under which such a modification actually exists.
New term: “high-risk machines”
The term “high-risk machinery” and the associated classification rules are also new. In principle, this term covers all machinery that could pose a risk to health due to its design and/or intended use. Annex I to Article 5 of the Machinery Ordinance contains the corresponding list.
The list of potential high-risk machines also takes into account the ongoing digitalization of machines and machine control systems. For this reason, machines in which AI systems perform safety functions have been included. The same applies to software that is used for safety tasks. This also includes AI systems in general.
Classification as a high-risk machine is based on both the probability and the severity of the potential damage. Relevant criteria include, for example, the number of people potentially affected, the degree of damage, the potential reversibility of the damage caused and several others.
However, for all machines that do not fall under the high-risk classification, there is the possibility of an internal inspection by the manufacturer to determine conformity.
NEW: RISK ASSESSMENT & AUTONOMOUS MACHINE BEHAVIOR
The risk assessment for safety and health protection is extended by the MVO for machines that are capable of evolving and autonomous behavior.
This means that the test must also take into account risks that may only arise after the machinery concerned has been placed on the market as a result of its autonomous behavior.
In future, a separate EU regulation on artificial intelligence will form the basis for assessing AI risks.
Digital operating instructions and declarations of conformity
The MVO also explicitly states that operating instructions and declarations of conformity can be provided by manufacturers in digital form. The prerequisite for this is clear information about this,
- where the digital version of the operating instructions can be viewed or downloaded;
- which version of the instructions corresponds to the machine product model.
For the digital operating instructions and declarations of conformity, it must also be ensured that they can be opened and saved on any end device. However, there were no clear specifications on this in the draft MVO. The requirement to be able to provide a paper version on request remains in place, however.
BIG TOPIC: DIGITALIZATION AND CYBER SECURITY
As the expansion of the concept of high-risk machines to include AI elements has already shown, topics relating to digitalization and cybersecurity have a large place within the MVO. There will therefore be adjustments in many areas.
Additions and adjustments to previous regulations
This applies, for example, to health and safety requirements for ergonomics, which in future will also include human-machine interactions. Adaptation of interfaces, the machine’s reaction to the operator or the communication of planned actions of the machine to the operator are some of the points that fall under this.
The requirements are intended to help reduce discomfort, fatigue and physical or mental overload. These and other requirements also apply to machines and systems with learning AI. These requirements include
- Safety and reliability of control systems,
- potential risks from moving parts and
- Ergonomics.
Basic requirements for IT security
Digitalization, artificial intelligence, the Internet of Things: these topics also determine the production of machines and systems. Against this backdrop, the security aspect is all the more important, particularly with regard to possible manipulation by third parties.
Additional risks can arise through the connection with other hardware (for example in intelligently networked industrial plants) or through attacks on the software of the machines from outside. The MVO therefore contains various basic requirements to ensure safety and health even under such conditions.
Among other things, the regulation requires that
- the connection to or communication with another device must not lead to dangerous situations;
- the design of safety-relevant components does not permit (unintentional or intentional) falsification through the connection of other devices;
- machines for the hardware components and for the software, evidence of lawful and unlawful intervention is documented;
- Software and data relevant to conformity with the health and safety requirements of the MVO are identifiable and specially protected against possible falsification.
The new cybersecurity requirements are not entirely new. They can be found, for example, in the regulations of the EU Cybersecurity Act (CSA) and in various harmonized standards and other directives. This means that there are already various certification procedures for products, services and processes in the IT sector. The MDR will presumably establish similar framework conditions for manufacturers, dealers, importers and authorized representatives of machines and systems.
Independent draft legislation for handling data and artificial intelligence
Regulations on artificial intelligence and the secure handling of data are to be dealt with in separate laws to a much greater extent than in the GDPR. The EU Commission is working on two new laws for this purpose:
- The “Regulation of the European Parliament and of the Council laying down harmonized rules on Artificial Intelligence (Artificial Intelligence Act)” has been under negotiation since 2021. Among other things, it defines various areas of application and risk classes on the basis of which the placing on the market, commissioning and use of AI products are to be regulated.
Due to the strong overlap between machines and the use of AI, there is a possibility that market participants will have to take both regulations into account in the future.
- The European Data Act is intended to facilitate access to data on the one hand and create clear regulations with regard to usage rights on the other. The aim is to facilitate the wider use of industrial data. The Data Act lays the legal foundations to clearly define rights and obligations for users, producers and data owners.
It remains to be seen exactly how these laws will affect companies in practice. Similar to the EU Machinery Regulation, the final versions of the two EU laws are still pending.
PREPARE NOW FOR THE REQUIREMENTS OF TOMORROW
Greater legal binding force, more clarity and the incorporation of important technical developments: With the new EU Machinery Regulation, the EU is endeavoring to adapt the previously valid directives to current circumstances and create the legal basis for further technical development.
The increasing health and safety requirements – such as the new focus on cybersecurity or the extended scope of application – take into account the growing risks to people and machines in Industry 4.0. For the EU’s internal market, the MDR means a single legal basis that all market participants can use as a guide in the future.
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