Focus on the new Machinery Regulation and Functional Safety

Guidance from the new EU Machinery Regulation

TÜV SÜD is preparing companies for the upcoming introduction of the new European Machinery Regulation, which will apply exclusively in the EU from July 2023 and after a transition period from January 2027. This regulation will replace the existing Machinery Directive 2006/42/EC and introduce important changes regarding machinery safety. The Machinery Regulation became valid in all EU member states immediately after its adoption and must be applied mandatorily 42 months after its entry into force, with the transition period ending on 20.01.2027. This means that manufacturers and operators in the EU must prepare for extensive changes in the area of machine safety. TÜV SÜD will provide information on the details at the SPS.

In particular, increasing digitalisation and networking in industry have given rise to new safety risks that were not or insufficiently addressed in the previous Machinery Directive. The Machinery Regulation will therefore introduce specific requirements for the cybersecurity of safety control systems and conformity-related software, the use of artificial intelligence in safety functions, and for autonomous and remote-controlled machines and collaborative robots (cobots).

The Machinery Regulation also introduces mandatory conformity assessment for six product categories by a Notified Body. This concerns specifically listed machinery and related products where there is a particularly high risk, such as vehicle lifts or self-learning machines. This conformity assessment also includes a type examination and concerns products listed in Annex I, Part A of the Machinery Regulation.

In addition, the scope of the Machinery Regulation will be extended so that the entire supply chain, including dealers of machinery and second-hand machinery, will have concrete obligations in relation to the new regulation. At the same time, the Machinery Regulation also brings simplifications as it enables the digitalisation of assembly and operating instructions as well as the EU declaration of conformity, which should reduce the administrative burden and costs for machinery manufacturers.

“Manufacturers should definitely start preparing for the new regulations now, as implementation is expected to take some time. This step is crucial to ensure compliance with the new regulations and to guarantee the safety of machinery and products throughout the EU,” emphasises Christian Moschner, Head of Sales at TÜV SÜD Product Service.

Functional safety: TÜV SÜD services for functional safety services

With increasing digitalisation and automation in all industrial sectors, the highest standards for the functional safety of products and systems have become essential. Whether it is “classic” plant safety in mechanical engineering, products or the growing threat of cybersecurity in the software and mechatronics industry, TÜV SÜD ensures the functionality and safety of electrical, electronic or programmable electronic systems through a wide range of tests based on industry-specific guidelines.

TÜV SÜD provides support from planning and market launch to proper disposal. The services include both the testing itself and support with design and installation, safety software, preliminary acceptance and modernisation advice. This comprehensive testing not only increases product quality, but also production efficiency and occupational safety, giving plant engineers and manufacturers a decisive competitive advantage.

Cybersecurity: Securing progress – compliance in the digital age

“More and more attackers are turning their attention to the IT security of automation technology,” explains Christian Moschner. “More needs to be done to ensure that processes are functionally safe and efficient at the same time.” With the help of cyber-physical systems (CPS) and networked components, modular plants can be built that make this possible. The international series of standards IEC 62443 entitled “Industrial Automation and Control Systems” provides the framework for IT security of cyber-physical systems in industry. Manufacturers, integrators and service providers benefit from the corresponding TÜV SÜD certification, both for the life cycle of secure product development and for the associated security programmes.

In addition to certifications, TÜV SÜD offers training and workshops, gap analyses, security risk assessments and threat modelling, as well as comprehensive testing and product assessments. Manufacturers of autonomous mobile robots (AMR), automated guided vehicles (AGVs) and electronic drive systems receive expert support from development to global market access. Other core topics are risk assessments and functional safety.

RED: Breaking down barriers – wireless innovation and compliance with RED guidelines

Delegated Regulation (EU) 2022/30 supplementing the Radio Equipment Directive (RED) 2014/53/EU will apply mandatorily from 1 August 2024, from which date many electronic products will have to undergo a conformity assessment with regard to the essential cybersecurity requirements set out in the RED before they can be placed on the EU market. TÜV SÜD supports manufacturers of wireless devices in meeting these requirements.

TÜV SÜD is approved as a Notified Body in the EU and authorised to assess products with regard to their conformity with the requirements of the RED. The scope of the RED includes electrical or electronic products that emit or receive radio waves for radio communication or radio location as intended. “TÜV SÜD has accredited test laboratories and highly qualified experts who are very familiar with the regulatory requirements. This means we are ideally placed to support customers around the world,” explains Christian Moschner.

About SPS

SPS is the flagship exhibition of the automation industry, showcasing the full range of smart and digital automation – from simple sensors to intelligent solutions, from what is feasible today to the vision of an extensively digitised industrial world. Under the motto “Bringing Automation to Life”, SPS acts as an idea generator and innovation platform for industrial communication, sensors and control systems. sps.mesago.com.

Further information about TÜV SÜD’s services for the manufacturing industry can be found at https://www.tuvsud.com/en/industries/manufacturing