テンダーラビングケアサービス List of Products and Services

On August 28, 2024, a notice was issued regarding the "Safety Regulations for Equipment and Electrical Appliances (Comprehensive Technical Regulations) 2024," announcing a revision notice "OTR Revision 2025" that postpones the enforcement start date from the previously scheduled August 28, 2025, to September 1, 2026, for approximately one year. For the regulated items, the application start date for equipment and electrical appliances will begin on the aforementioned September 1, 2026, while the application start dates for the following will be announced separately: - Assembly items - Sub-assembly items - Components Additionally, details regarding the treatment of components and other items are expected to be announced in the future. OTR mandates the acquisition of certification from BIS (Bureau of Indian Standards) for a wide range of equipment and electrical appliances distributed domestically, or the acquisition of a Certificate of Conformity (CoC) in accordance with "Scheme X," and compliance with the safety standards specified by OTR.

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To export products such as industrial machinery and electronic devices to EU member states, understanding regulations, including CE marking, is essential. Without sufficient knowledge, there is a risk of being stopped at customs, and in the worst case, it could lead to removal from the European market or a sales halt. Therefore, it is important to grasp the relevant basic knowledge. Our company, which has 15 years of experience in supporting CE mark conformity declarations, Tender Loving Care Services, is currently offering a technical document titled "Basic Knowledge of CE Marking - Easy CE Marking" for export and technical personnel in their first to fifth years of employment. This document clearly explains CE-marked products, a list of directives and regulations, and the concept of risk assessment. It is available for anyone to download, so please take this opportunity to check it out. [Contents] - What is CE marking? - European legal system - What are the applicable directives and regulations? - What is the conformity assessment module? - Let's think together about risk assessment - Legal obligations of manufacturers - Penalties for violations - Summary *Please view the technical document via PDF download or contact us for more information.

• Technical and Reference Books

The technical document "Basic Knowledge of CE Marking: Easy CE Marking 2025" provides a simple explanation for those in their first to fifth year of employment at industrial machinery and electronic equipment manufacturers in Japan, serving as an introductory guide for exporting to Europe. It also introduces the various international safety standards and types of regulations required for overseas exports, as well as the penalties for violating European regulations, making it a useful reference. [Contents] ■ What is CE Marking ■ European Legal System ■ Relevant Directives and Regulations ■ What is the Conformity Assessment Module ■ Let's Consider Risk Assessment Together ■ Legal Obligations of Manufacturers ■ Penalties for Violations *For more details, please download the PDF or feel free to contact us.

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In today's digital society, as the risk of cyber attacks on internet-connected devices increases, security is becoming increasingly important. To address this cyber risk, the European standard EN 18031 has been released. EN 18031 was officially announced on August 30, 2024, approved by the European Commission on January 28, 2025, and published in the Official Journal of the European Union on January 30. The delegated regulation (EU) 2022/30 referring to this standard for the Radio Equipment Directive (RED) is scheduled to become mandatory on August 1, 2025. At Overseas Certification PRO, we conduct individual study sessions primarily for industrial machinery manufacturers and electronics manufacturers. We will tailor our proposals to fit your company's situation and the level of the participants. Please feel free to contact us.

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The content amends Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repeals Directive 94/62/EC. It will come into effect on February 11, 2025, and will be applicable from August 12, 2026. This signifies a significant change in the approach to product compliance related to packaging and waste management, with the PPWR mandating a conformity assessment of packaging that culminates in an EU declaration of conformity. Notably, Article 12 outlines a blueprint for future packaging labeling requirements. The European Commission is tasked with presenting implementing acts by August 12, 2026, to establish a harmonized labeling system. These requirements extend to the specifications and formats of packaging labels, including those created through digital means, and must utilize standardized open digital labeling technologies to display any substances of concern (SoC) defined in the Eco-design Framework Regulation (EU) 2023/1542 if they are included in the packaging, as defined by future legislation. This regulation will be directly applicable in all Member States from August 12, 2026. For more details, please refer to the related links or feel free to contact us.

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The technical document "Basic Knowledge of CE Marking: From Machinery Directive to Machinery Regulation" provides a simple explanation as an introductory guide, focusing on the conformity procedures when CE marking under the Machinery Regulation (MR). It covers topics such as "Changes from the Machinery Directive to the Machinery Regulation (8 Key Points)," "Scope of Application of the Machinery Regulation," and "Order of Conformity." It also introduces "Frequently Asked Questions about the Machinery Regulation," making it a handy reference. **Contents:** - The Machinery Directive has been upgraded to the Machinery Regulation. - Changes from the Machinery Directive to the Machinery Regulation. - What is the Machinery Regulation (2023/1230/EU)? - Scope of Application of the Machinery Regulation. - Order of Conformity to the Machinery Regulation. - Conformity to the Machinery Regulation and Document Compilation. - Frequently Asked Questions about the Machinery Regulation. - For those considering reviewing the DoC (Declaration of Conformity) and TCF (Technical Documentation). *Please view the technical document via PDF download or contact us for more information.*

• Technical and Reference Books

On November 30, 2023, the International Organization for Standardization (ISO) issued the revised version 4 of ISO 13849-1. As one of the most important standards in the group of international standards for machine safety (Type B standards), "ISO 13849-1" specifies the design principles for safety-related parts of control systems. This standard evaluates the safety performance of control systems in terms of Performance Level (PL) as a condition to determine whether it is appropriate to implement risk reduction using control systems after conducting a risk assessment of the machinery. It stipulates that the PL must be at least the required PLr to reduce risks. When placing machinery on the market in Europe (EU), it is necessary to comply with the Machinery Directive (which will become the Machinery Regulation in 2027), and the harmonized standard EN ISO 12100 outlines the procedures that must be considered when conducting risk assessments and risk reduction for machinery. Recently, there has been an increase in inquiries, and it has been decided to hold a seminar on April 18 (Thursday) in Otemachi, Tokyo, inviting experts to discuss the overview and changes of this standard, as well as risk assessment for machinery.

• Business Skills Seminar

This seminar has been closed as it has reached its capacity. ▶ Click here for the event report https://tenderlove-pcb.biz/news/thanks20240220/ 【Recommended for】 - Companies in industrial machinery / industrial electronic devices - Quality assurance practitioners - Overseas sales / promotion personnel - Beginners to intermediate in CE marking 【Course Highlights】 To launch industrial machinery in Europe, understanding CE marking, machine safety, and EMC is essential. By taking this course, you will gain a comprehensive understanding of CE marking and be able to smoothly advance CE marking within your company. 【Agenda】 - Basic knowledge of CE marking - From machinery directive to machinery regulation - Break time - Overview of cyber resilience

• Technical Seminar

Original text: Machinery Regulation (2023/1230/EU) A significant change is that the current Machinery Directive (2006/42/EC) has been updated to address many issues related to recent technologies (such as AI (Artificial Intelligence), cybersecurity (cyber resilience), and online sales) that it does not fully cover. This includes the addition of requirements and changes in the chapter structure to align with other CE marking directives. Furthermore, the purpose of transitioning to the Machinery Regulation (2023/1230/EU) is to address the technological advancements since the Machinery Directive (2006/42/EC) was amended on December 29, 2009. The current Machinery Directive (2006/42/EC) has not kept pace with recent technologies (such as AI, cybersecurity, and online sales), leading to inconsistencies (inappropriateness, inconveniences, ambiguities) and issues such as inconsistent market surveillance. Improving these various problems is a major objective. *The original text is available on our website. https://tenderlove-pcb.biz/column/kikaikisoku2023/

• Business Skills Seminar

*This seminar is fully booked and has been closed for registration.* Recently, there has been an increase in companies trying to expand their markets overseas due to the impact of the weak yen. Global product safety is defined by various countries in accordance with ISO and IEC standards set by the WTO, including Japan (JIS), Europe (CE), the UK (UKCA), Canada (CSA), North America (NRTL, FieldLabel), China (CCC), and South Korea (KC, KCs). Not understanding these regulations can lead to various problems. "Overseas Certification PRO" assists with the declaration and acquisition of product safety certifications aimed at Europe and North America. We have received many inquiries from both domestic and overseas (Japanese companies) businesses, and we have discussed and resolved issues such as: (1) Stopped at customs (2) Requested by end users in business negotiations (3) Wanting to reduce costs for declarations and certifications (4) Seeking information about the regulations, etc. In this seminar, we will particularly explain about Europe, the UK, and North America, which have received many inquiries. We will discuss what the first steps are towards the declarations and certifications required when expanding overseas, as well as the key points of the regulations.

• Technical Seminar

As globalization progresses, opportunities to export products not only domestically but also overseas are increasing. One important point to keep in mind during this process is to strictly comply with the standards and regulations of each country. When exporting to European countries, the "CE mark" is essential. Even if you are aware of the existence of the CE mark, many may not fully understand the difference between products that are subject to it and those that are not. This article will explain the products subject to CE marking and those that are exempt, along with the handling of components and embedded products. *For detailed content of the column, please refer to the related links. For more information, feel free to contact us.

• Technical and Reference Books

CE marking is not something to be done on your own; there are specific procedures established. There are six steps prepared, such as testing the product to confirm whether it complies with the "directive," affixing the CE mark, and creating an EC declaration of conformity. There are many cases where failing to comply with CE marking can lead to legal violations and penalties, so be sure to consult with a consultant or expert for confirmation. 【Steps (partial)】 1. Test the product to confirm whether it complies with the "directive." 2. Check the "product-specific requirements" and select "harmonized standards" or "other technical means" used to demonstrate compliance with the "essential requirements" of the directive. 3. Confirm the necessity of third-party evaluation by a "Notified Body" designated by the national authorities of EEA member countries and Turkey. *For more details, please refer to the related links or feel free to contact us.

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Importers and distributors of products have the obligation to verify that the products comply with the law as declared by the manufacturer and that the CE marking is affixed. Importers must always be in a position to inquire with the manufacturer regarding the CE marking. Distributors need to have basic knowledge about whether the products they handle require CE marking accompanied by a "technical file." [Reasons for the obligations] - To protect the health, safety, and environment of product users and consumers. - To ensure that market participants can engage in "fair competition." *For more details, please refer to the related links or feel free to contact us.

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The CE marking is a label that indicates that a product has undergone an evaluation procedure to ensure compliance with all applicable EU harmonization legislation (laws) before being placed on the EU market or affixed to the product before it is used. To achieve this, manufacturers must conduct an assessment in advance to ensure that the product meets the essential requirements of all applicable directives before affixing the CE marking to the product. Manufacturers are required to evaluate and confirm that their products comply with EU laws and provide evidence of this compliance. [Methods of Certification] ■ CE marking ■ EC Declaration of Conformity ■ Technical file (technical documentation) *For more details, please refer to the related links or feel free to contact us.

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If the affixing of the CE mark is stipulated by the New Approach Directive, it is mandatory to affix the CE mark before distributing or selling the product. Manufacturers must ensure in advance whether the product they intend to distribute or sell falls under the New Approach Directive. Even if a product falls under multiple New Approach Directives, it is indicated that it complies with all regulations with a single CE mark. 【Target】 ■ Products manufactured in EU member states, candidate countries, and EFTA member countries ■ Products exported to EU member states, candidate countries, and EFTA member countries ■ Used goods exported to EU member states, candidate countries, and EFTA member countries, etc. *For more details, please refer to the related links or feel free to contact us.

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Countries and regions that require CE marking include the 27 member states of the EU (European Union), as well as Iceland, Norway, and Liechtenstein, which make up the European Economic Area, and Turkey, which is a candidate for EU membership, totaling 31 countries. Among the EFTA member states, only Switzerland has mutual recognition agreements (MRAs) that mutually approve safety and quality standards. 【Countries that require CE marking (partial list)】 ■ France ■ Italy ■ Cyprus ■ Slovenia ■ Finland ■ Portugal *For more details, please refer to the related links or feel free to contact us.

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The "CE mark" is a mark that certifies that products being considered for export comply with the laws of EU member countries (European Union). Despite the obligation to affix the CE mark, it is not permitted to market or distribute products without it. There are a total of 24 types of directives and regulations for the CE mark, and rather than matching one directive to one product, some products must comply with multiple directives. 【Directive Names (Excerpt)】 ■ Low Voltage Directive (LVD) ■ Machinery Directive (MD) ■ Electromagnetic Compatibility Directive (EMC Directive) ■ Explosive Atmospheres Directive (A-TEX Directive) ■ Pressure Equipment Directive (PED) *For more details, please refer to the related links or feel free to contact us.

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*This seminar is fully booked and has been closed for registration.* We would like to inform you that we will be holding a CE marking and CE mark seminar in Osaka on December 16th (Friday). This will be a face-to-face lecture for the first time in a while. Customers near the venue are encouraged to consider attending. Theme: CE marking and risk assessment for machinery for industrial machinery manufacturers.

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*This seminar is fully booked and has been closed for registration.* Theme: Two-week event - Let's deepen our understanding! CE marking for machinery, Part 1 & Part 2 Date and Time: [Part 1] June 23 (Thursday) 13:00 - 15:00 (2 hours) [Part 2] June 28 (Tuesday) 13:00 - 16:00 (3 hours) Venue: Online via Zoom Participation Fee: Free (You can attend both parts or just Part 1 or Part 2) Instructors: Yasushi Yoshikawa (Representative Director of Face Co., Ltd. / Specialist Consultant at MTEP (Tokyo Metropolitan Industrial Technology Research Institute) / Part-time Lecturer at Nagaoka University of Technology) Takashi Kairishi (Director of Tokyo Lab at Face Co., Ltd. / Certified EMC Engineer by iNARTE, USA) <Face Co., Ltd.> Support for safety design, risk assessment, European CE marking, safety verification, and EMC testing for industrial machinery in North America and South Korea. Experts in machine safety and EMC.

• Technical Seminar

Our company provides support for CE marking compliance as a coordinator, including research on relevant directives and harmonized standards, arranging testing laboratories, assistance with corrective actions in case of non-compliance, support for risk assessments and technical document preparation, and ultimately affixing the CE mark. We assist at each step of the CE marking compliance process. Rather than simply aiming for CE marking compliance for the relevant products, we contribute to reducing costs and time associated with CE marking compliance and improving productivity through our support that enables companies to handle their own compliance. 【Main Contents Leading to CE Compliance Support】 ■ Gap Analysis: Evaluation of the differences between the actual product and the relevant standards ■ Plan Creation: Development of a testing plan ■ Testing Implementation: Conducting tests at accredited laboratories and on-site ■ Report Issuance: Creation of evaluation reports that demonstrate compliance with the standards ■ Seminars: Hosting seminars (standards interpretation seminars and customized sessions) ■ Regular Support: On-site support assistance (typically in 3-month to 1-year intervals) *For more details, please refer to the PDF document or feel free to contact us.

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