Safe machinery is the result of thoughtful design, sound risk assessment and clear legal requirements. From 2027, a new regulatory framework for machinery safety will apply in Europe: the Machinery Regulation (EU) 2023/1230. For the first time, these new provisions cover digital risks and set higher requirements for cybersecurity, software and self-learning systems. Companies should prepare for these changes now.
The currently applicable Machinery Directive 2006/42/EC has for many years formed the central European legal framework for machinery safety. Its scope extends not only to classic machinery, but also to partly completed machinery, interchangeable equipment, safety components as well as lifting accessories, chains, ropes, webbing and universal joints. The Directive thus regulates a broad spectrum of safety-relevant products. In Germany, its implementation is effected via the 9th Ordinance to the Product Safety Act. Standards play a crucial role in practical application, assisting manufacturers in systematically implementing requirements and demonstrating the state of the art.
Transition phase until 2027
The transition from the Machinery Directive to the new Machinery Regulation presents many companies with organisational and technical challenges. Until 19 January 2027, machinery will continue to be placed on the market under the Machinery Directive. From 20 January 2027, however, only the new Machinery Regulation must be applied. For manufacturers, this means a phase in which both sets of rules play a role in parallel – particularly in ongoing product developments or in series production. To facilitate the transition, the European Commission has introduced a combined EC/EU declaration of conformity. This makes it possible to draw up a single declaration that confirms conformity with both the Machinery Directive and – provided all requirements are met – the Machinery Regulation.
Importance of the conformity assessment procedure
The conformity assessment procedure is the primary proof that a machine has been safely designed and meets all legal requirements. It is a multi-stage process that begins during the design phase and takes into account the entire life cycle of a machine. The resulting technical documentation often comprises several hundred pages. Only a small portion of this is later passed on to the operator – such as the operating instructions, the EC/EU declaration of conformity, and additional safety information. The vast majority of the documentation remains with the manufacturer as internal evidence. A particular challenge is that not only the intended use, but also „reasonably foreseeable misuse“ must be taken into account.
Especially with regard to the extended requirements of the new Machinery Regulation, it will make sense for many companies to handle these tasks in an interdisciplinary team or to involve specialised service providers. „Even if the actual content of the conformity assessment does not change, the transition to the new structure of the MR leads to a considerable administrative burden,“ says Jens Müller, CMSE Managing Director of Müller und Partner Sachverständige and ISO/IEC 17024 certified expert for robotics and machine safety. „Article numbers, section references and annexes have been completely reorganised. Therefore, technical documentation, declarations of conformity and internal processes must be adapted – even for existing products.“
What changes with the new Machinery Regulation
With the new Machinery Regulation, two key aspects are clearly regulated for the first time: the concept of a „substantial modification“ and an expanded concept of risk that explicitly takes modern technologies into account. A modification is considered substantial if it is not foreseen by the manufacturer and causes new or increased risks. In this case, the machine must be treated like a new product and a full conformity assessment procedure must be carried out again. At the same time, the regulation introduces an expanded view of risks. For machines with autonomous, learning or evolving functions – for example in AI-supported control systems – risks arising after placing on the market will also have to be taken into account in future.
The Machinery Regulation thus creates greater clarity, but also increases the demands on design, documentation and risk assessment – especially in the case of modern, software-driven systems. With the right planning, however, safety requirements can be implemented in a standard-compliant, modular and understandable way. „Companies should plan the transition early on and examine processes closely,“ emphasises Jens Müller. „This ensures that the new Machinery Regulation is implemented efficiently. Specialised service providers can offer optimal support during this process.“
Further information, such as concrete examples on the secure design of applications with Item, can be found in the complete White paper to find.
Source: Item Industrietechnik
