From Cybersecurity to Risk Assessment: The Biggest Challenges in Implementing the Machinery Regulation

1.  Cybersecurity: To minimize security risks posed by cyberattacks, threats must be assessed accordingly. Software, firmware, and security-critical components of control systems must not be subject to modification or manipulation that could compromise the safe operation of the machines. The EN 50742 standard is intended to describe how protection against corruption should be implemented in practice. However, this standard is still in the draft phase.
2.  Risk Assessment: The MR requires the assessment of potential hazards and the documentation of protective measures. This applies not only to functional safety but also to cybersecurity. However, EN 12100, the most important standard for risk assessment, is currently being revised. To prepare for the risk assessment, companies should assess their current situation, taking into account new aspects such as cybersecurity, artificial intelligence, and digital operating instructions.
3.  Substantial modifications: The MR establishes the concept of a substantial modification in European law for the first time. Anyone who makes a substantial modification to a machine is legally considered the manufacturer and bears full responsibility. Substantial modifications can involve both hardware and software. As a result, operators will more frequently become manufacturers in the future, which entails significant effort and will be difficult for many operators to manage without support from suppliers. If a substantial modification is made, a new conformity assessment procedure is also required. Retrofitting which may be necessary, particularly for older machines will in many cases no longer be economically viable.
4.  Notified Bodies: For certain products and product groups, the MR requires the involvement of a Notified Body. For products and product groups listed in Annex I, Part A, a Notified Body must always be involved in the conformity assessment. Annex I, Part B lists machinery with a high risk potential for which a Notified Body must generally be involved if no harmonized standard exists, if a harmonized standard does not cover all health and safety requirements, or if there is a deviation from a harmonized standard. The contents of Annex I, Parts A and B, could still change, even though it does not currently appear likely that the European Commission will make any further amendments.
5.  Harmonized Standards: Until now, manufacturers have been able to place certain products on the market themselves in accordance with harmonized standards. Under the old Machinery Directive, there were approximately 800 such standards. For the new Machinery Regulation, all standards must be reharmonized, and significant delays are expected due to legal uncertainty. If no harmonized standards are available for certain products, a Notified Body must also be involved in the approval process for those products.

A fast and efficient way to demonstrate the CE conformity

TÜV SÜD Product Service GmbH is a Notified Body for most products and product groups listed in Annex I of the MR. “In addition, we have developed processes and testing procedures that allow us to assess and certify compliance with new requirements in areas such as cybersecurity and AI, even in the absence of harmonized standards,” says Benedikt Pulver, Head of the Machine Safety Department at TÜV SÜD Product Service. “This allows us to offer manufacturers a fast and efficient way to demonstrate the CE conformity of their machines and components based on the Machinery Regulation.”

TÜV SÜD is one of the leading testing and certification companies in the field of machine safety. Its experts are well-versed in national and international standards and support companies in implementing the MVO and in determining which conformity assessment procedure must be applied. “Based on our experience so far, the effort required for the transition is often underestimated,” reports Rudolf Bültermann, a machine safety expert at TÜV SÜD Industrie Service GmbH. His assessment: Anyone who has not yet addressed this issue and does not act quickly now will find themselves in serious trouble.

For more information about TÜV SÜD´s services in this area, visit tuvsud.com/en/machineryregulation.