テンダーラビングケアサービス Company Overview

"There is already a manual compliant with CE standards. For the North American market, it should be fine to use the English version as it is." This way of thinking has a significant pitfall. In the North American market, the safety information in manuals is governed by ANSI Z535.6, and electrical safety is covered by NFPA 79, which are different regulatory frameworks from those in the EU. Additionally, a unique aspect of the United States is that deficiencies in manuals manifest not as administrative guidance but as product liability (PL) lawsuits. "Failure to Warn" is a typical point of contention in U.S. PL lawsuits. In this issue, we will explain why simply translating the EU manual into English does not comply with North American standards from three perspectives: the safety message format of ANSI Z535.6, the electrical safety requirements of NFPA 79, and the alignment with OSHA's lockout/tagout (LOTO) regulations.

To those responsible for exporting machines equipped with PLCs, touch panels, and network connections to the EU, which may also include CE-marked products: "We are already compliant with CE marking and are progressing towards compliance with the Machinery Directive." — However, after December 2027, there may be another regulatory compliance requirement. The EU Cyber Resilience Act (CRA: Regulation (EU) 2024/2847) is the EU's first horizontal cybersecurity regulation that applies to all products capable of processing and exchanging digital data. The CRA is a regulation that applies separately from the Machinery Directive and Machinery Regulations. In this issue, we will organize the requirements for documentation that the CRA mandates, based on the text of the regulation, and inform you of the differences from existing documentation and the preparations that should be undertaken now.

When companies start considering overseas expansion, many feel, "I don't know where to begin." Not only do they need to develop sales channels and conduct market research, but they also have to obtain certifications and comply with regulations, which can be a significant burden if they try to proceed on their own. However, by utilizing the programs offered by public institutions and local governments that support overseas expansion, they may be able to reduce the burden of information gathering and costs.