Category: European Union

EU-type Examination Certificates for Importers: A Practical Guide

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EU Type Examination Certificate

Many products that require the CE mark can be ‘self-certified’ in the sense that you as an importer or manufacturer can arrange testing and prepare documentation (e.g. DoC and technical file) entirely on your own. However, when it comes to some product categories – an external review of the compliance procedure, including the DoC and technical file, is required.

In this guide, we explain how this works and why an EU-type examination certificate is a central component in this process.

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CE Marking Responsibilities for Importers: A Complete Guide

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CE Marking Responsibilities for Importers

Planning to import electronics, toys, protective equipment, or medical devices to the European Union? If yes, then you need to ensure that your imported products are correctly CE marked. However, CE marking is far more complex than simply affixing the compliance mark itself.

In this guide, I explain the CE marking process, including risks and common misconceptions, when importing products to the European Union. Continue reading CE Marking Responsibilities for Importers: A Complete Guide

EN 71 Toy Safety Lab Testing: A Complete Guide

Posted on by Fredrik Gronkvist — 10 Comments

EN-71 lab testing

EN 71 is harmonised in the European Union, under the Toy Safety Directive. This means that toys imported and manufactured in the EU must be fully tested and compliant with all applicable EN 71 standards.

In this guide, we explain what EN 71 is, how to assess which parts apply, whether testing is mandatory, costs, and much more.

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Button and Coin Battery Safety Standards and Regulations in the EU

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EU Button and Coin Battery Regulations

Button and coin batteries can be found in toys, remote controls, quartz watches, and various other products. Button and coin batteries are also potential safety hazards if swallowed. These batteries are therefore subject to safety standards and regulations in the European Union – which we cover in this guide. Continue reading Button and Coin Battery Safety Standards and Regulations in the EU

List of CE Marking Service Companies: Our Top 11 Picks

Posted on by Vincent Cheng — 7 Comments

Looking for a consultant or other service provider to help you understand CE marking? In this article, we list software tools, consulting companies, and testing and certification companies offering a wide range of CE mark-related compliance services.

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CE Certificate of Conformity: A Complete Guide

Posted on by Fredrik Gronkvist — 2 Comments

CE Certificate Conformity

A CE Certificate of Conformity (CoC) essentially states that a certain product is compliant with one or more regulations, directives or standards. It also includes information about the conformity assessment performed, the issuing company, product information, and supplier.

In theory, this certificate is issued based on the issuing company reviewing or creating certain documents. This includes test reports and technical files.

However, as I will explain in this guide, far from all documents titled ‘Certificate of Conformity’ are valid and based on an actual conformity assessment. In short, many of these documents are invalid and can result in your products being subject to a recall, fines, or other penalties. Continue reading CE Certificate of Conformity: A Complete Guide

Packaging Recycling and Sustainability Symbols in the EU: An Overview

Posted on by Chuiyan Mo — 3 Comments

EU recycling Packaging Symbols

Packaging symbols are used to indicate whether it is recyclable, made using sustainable materials, or requires separate collection.  In this guide, we explain what importers and manufacturers in the European Union must know about packaging recycling and sustainability symbols such as the Mobius loop, Green Dot, WEEE symbol, OK Compost Label, and the FSC Recycled symbol.

Even though using some of these schemes and symbols are voluntary, companies that use recyclable and sustainable packaging materials might still get a competitive advantage due to the fact that more customers prefer buying sustainable products. Also, some retailers might refuse to purchase your products, if your product or packaging is not recyclable or is made using sustainable materials.

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Which Countries Accept CE Marked Products?

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CE mark Accepted

CE marking is mandatory for electronics, toys, medical devices, PPE, and many other products in the European Union. That being said, the CE mark is sometimes compulsory for certain products in countries outside the EU – including Turkey. In other countries, certain aspects of the CE mark process – such as EN standards – are recognized.

In this guide, we explain what you need to know about the status of CE-marked products and EN standards in the United Kingdom, Turkey, Israel, Switzerland, Singapore, Australia, the United States, and elsewhere.

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Product Risk and Safety Assessment in the European Union: An Overview

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EU Risk Assessment

A Risk and Safety Assessment can be described as a document that lists potential safety hazards, and how you as an importer or manufacturer will act in case any of these risks become reality. Creating a risk and safety assessment document is mandatory when importing and manufacturing a range of products in the European Union, and that is what we cover in this guide.

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Magnet Safety Standards & Regulations in the European Union: An Overview

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Magnet Regulations EU

Magnets and products that contain magnets carry ingestion and other types of hazards, especially for young children. In this article, we cover EU regulations and EN standards that manufacturers, brands, and importers of magnets or magnetic materials need to comply with before selling in the EU. Continue reading Magnet Safety Standards & Regulations in the European Union: An Overview