In the previous issue (Vol. 3), we organized the impact of the transition to machine regulations on the practical aspects of instruction manual creation. This time, we will take a further step and focus on the practical aspects of the design process regarding "when, who, and how should instruction manuals be created." In response to the question of "when should we start writing the instruction manual," the standard provides a clear answer. ISO 12100 requires that the results of risk assessment be reflected in three stages: design, protective measures, and information provision, positioning the instruction manual as the final output of the design process under "information provision." Practically speaking, it is ideal to start creating the instruction manual simultaneously from the stage of defining requirements and initiating the initial risk assessment. In this issue, we will clarify the relationship between the ISO 12100 three-step method and instruction manuals, outline specific instruction manual tasks and internal role distribution for each design phase, and present four checkpoints that should be incorporated into the design review.

In the previous issue (Vol. 2), we organized the common deficiencies pointed out in the instruction manuals. In this article, as a continuation, we will specifically explain the changes in the instruction manuals resulting from the transition from the Machinery Directive to the Machinery Regulation. As of January 20, 2027, the regulations applicable to machinery exports to the EU market will switch from "Machinery Directive 2006/42/EC" to "Machinery Regulation EU 2023/1230." The change from "Directive" to "Regulation" is not just a matter of terminology. There are several changes that require direct attention from those responsible for technical documentation and instruction manuals. In this issue, we will outline the impact of the transition to the Machinery Regulation on practical instruction manual work and highlight the points that should be addressed starting now.

CRA: The reporting obligations under the European Cyber Resilience Act will begin in September 2026. In preparation for Article 14, which mandates the reporting of vulnerabilities and significant incidents, companies such as industrial machinery manufacturers and electronics manufacturers are working to establish internal systems. Did you know that "Our products do not connect to the internet" and "We have previously declared CE marking for products, but we are not currently selling them" could also fall under the scope of the CRA? In this "free assessment," you can clarify what you should do first under the CRA by simply answering five questions.

In the previous issue (Vol. 1), we organized the reasons why the instruction manual is pointed out during the review process. In this article, as a continuation, we will specifically explain the common "deficiency patterns." To those in charge of companies aiming for CE certification or who have just completed it: "We have arranged the design and safety measures. Yet, we were pointed out for deficiencies in the instruction manual during the review." Such voices are repeatedly heard in the field of CE compliance. Annex I §1.7.4 of the Machinery Directive/Machinery Regulations establishes the content requirements for the instruction manual as an independent chapter, and the certification body clearly checks that section. Deficiencies in the instruction manual are returned not as design issues but as "document issues." This time, we will organize five recurring deficiency patterns that arise in the review process, along with the relevant standard clauses. Please check this to prevent rework in CE compliance.

This column is a special series consisting of 12 installments themed around user manuals. In the first installment, we will focus on the often-overlooked "risks of postponing the user manual" in relation to CE marking compliance. In the process of obtaining CE marking, attention is often concentrated on design and safety measures, leading to cases where the preparation of the user manual is delayed. However, in practice, deficiencies in the user manual can lead to the following issues: - Rejection just before the review - Increased costs due to design revisions - Schedule delays - Product liability (PL liability) risks after shipment Even if CE marking is obtained, it is important to be aware that insufficient information provision can leave risks associated with the product.