How can legal requirements for machinery be implemented and maintained throughout its entire lifecycle? Machine manufacturers and operators must now address this question, as the EU Machinery Directive 2023/1230 will take effect on January 20, 2027. This also brings industrial security and digitalization to the forefront. Both aspects will require a structured approach and comprehensive documentation in the future.

Manufacturers and operators are affected by the changes and new provisions of the Machinery Regulation in different ways. Manufacturers focus on developing compliant and safe machines. They integrate safety aspects from the very beginning, both technically and in their documentation. Operators, on the other hand, are responsible for safe operation—they must use systems correctly, train employees, and adhere to processes. The manufacturer lays the foundation, and the operator maintains it throughout the machine’s entire lifecycle.

Closer Collaboration for Greater Security

Regulators require operators and manufacturers to demonstrate controlled management of the entire lifecycle—from design, operation, and maintenance through decommissioning—including the handling of software and updates. Consequently, the focus is shifting from one-time certification to continuous compliance. Appropriate safety measures are identified and implemented at the start of the lifecycle through a risk assessment. In addition, a security assessment now identifies which measures are necessary to achieve the operator’s security objectives. In the future, closer collaboration between machine manufacturers and operators will be required to bring technical documentation, safety and security mechanisms, update processes, and risk assessments up to a level compliant with the Machinery Directive.

Maintaining an Overview During Operation

With their many years of expertise in all aspects of CE marking, the safety experts at PILZ support both manufacturers and operators in implementing safety and security requirements right from the start. To ensure that all supporting documentation can be quickly accessed centrally, this entire conformity process and the associated documentation are thoroughly recorded. The manufacturer can decide to what extent it shares its technical documentation with the operator.

But how can the required continuous compliance be achieved after successful commissioning? Production managers, safety officers, or management—those responsible for production and safety face the daily challenge of keeping track of machines and personnel.

Digital Documentation with Added Value

The need to manage documents and authorizations in a structured manner is growing. This applies equally to organization, processes, qualifications, and IT security. Without integrated asset management that takes legal and regulatory aspects into account, “Secure by Design” and verifiable safety compliance are virtually impossible to achieve in day-to-day operations. Those in charge must comprehensively document qualifications, inspections, maintenance intervals, change statuses, evidence, and access rights—across all locations and systems. Excel spreadsheets and paper files are no longer up to the task; they are error-prone, pose audit risks, and slow down response times in the event of an incident.

A platform that connects people and machines

The automation company PILZ addresses these increased requirements with the MYZEL Lifecycle Platform—a Software-as-a-Service solution for people and machines. MYZEL consolidates personnel and machine data into a single system and assigns relevant artifacts (instructions, assessments, validations, declarations of conformity, maintenance plans, training records). This provides real-time visibility into compliance status. At the heart of the platform is myCore. Here, users create entries for their machines and centrally store all relevant information. Deviations, missing documentation, or expiring deadlines related to assets (machines, data, people) are immediately visible on a dashboard. The platform thus offers a clear overview of safety-critical aspects and highlights areas requiring action. An audit log also records every action in the system in a traceable manner.

To meet the requirements of the Machinery Regulation, manufacturers and operators can use MYZEL as a shared platform: The manufacturer or a consulting firm such as Pilz can use it to transfer a machine’s documentation to the operator. As a complete package, Pilz offers the right combination of services and complementary software to support manufacturers and operators on their path to continuous compliance. An import function allows information to be easily transferred into MYZEL, enabling centralized documentation that begins at the start of the machine’s lifecycle and can be seamlessly continued.

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