Category: European Union

Labelling Requirements for CE Marked Products

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Labelling Requirements for CE Marked Products

CE marking must be affixed correctly, in terms of the symbol used, but also placement and size. Further, products subject to CE marking requirements must generally also meet additional labelling requirements concerning traceability, instructions, and warnings.

In this guide, we take a closer look at how CE marks must be affixed and other labelling requirements that often come together with CE marking requirements.

Note: This article uses the PPE Regulation and the Council Directive 93/68/EEC as the reference points. That said, the same principles can be found in most other regulations and directives mandating CE marking for toys, electronics, batteries, medical devices, and other requirements.

CE Mark Sample: You can find CE marking label samples at the end of this guide. These samples are based on specific articles from EMC Directive.
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Which Products Should Not be CE Marked?

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Which Products Should Not be CE Marked?
Not sure if your product requires CE marking? In this guide, I explain how you can determine if CE marking is not required for your product. I also list product categories that are generally not subject to CE marking requirements, while also explaining edge cases when CE marking is still applicable.
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Which Products Require an EU Notified Body?

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Which Products Require an EU Notified Body?

Certain products require the involvement of a notified body before they can be sold in the European Union. Whether that is the case depends on the applicable EU regulations and directives, and whether the product belongs to a certain category.

In this guide, we provide examples of product types that require the use of a notified body, while also explaining the basis.
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How to Create an EU Declaration of Conformity for Personal Protective Equipment (PPE)

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How to create an EU Declaration of Conformity for PPE

This guide explains how to create an EU Declaration of Conformity for PPE based on the model structure in Annex IX of the Personal Protective Equipment (PPE) Regulation. You will learn what to include under each of the 8 points, while I also address common questions.
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EUDR Due Diligence Statements: An Essential Guide

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EUDR Due Diligence Statement

The Deforestation Regulation (EUDR) contains due diligence requirements to ensure products contributing to deforestation are not imported, sold within the EU or exported. The regulation mandates the submission of a due diligence statement, which is a document used to indicate that companies have complied with the applicable EUDR requirements.

This guide covers frequently asked questions about EUDR due diligence statements, including which types of operators are required to submit one and which are exempt.
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EU Conformity Assessment Procedures: A Complete Guide

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EU Conformity Assessment Procedures

A conformity assessment procedure provides a pathway to compliance for certain EU regulations or directives that require CE marking. In practice, conformity assessment procedures set a list of tasks that must be completed to demonstrate compliance. This generally involves compliance with standards, documentation, labelling, and testing.

In this guide, we explain how you can determine which conformity assessment procedure to follow for your products, and the steps you must take to successfully complete the procedure.
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Notified Bodies in the European Union: An Overview

Posted on by Ivan Malloci — 6 Comments

Notified bodies are organisations designated by EU member countries that perform conformity assessments on products before they are sold.

The role of a notified body is to assess whether a product is technically safe and compliant. In a way, the notified body acts as a gatekeeper to the EU market for more ‘high-risk’ and ‘sensitive’ products that cannot be ‘self-assessed’.

That said, notified bodies are not government organisations. Instead, companies like Intertek and TÜV Rheinland are appointed to act as notified bodies for certain product categories.

In this guide, we explain what manufacturers and importers must know about notified bodies and how they operate.
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European Union Authorised Representatives: A Complete Guide

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Request a free EU Authorised Representative Quotation Here

Article 4 of the Market Surveillance Regulation (EU) 2019/1020 states that products can only be sold in the European Union if there is an economic operator established there. This can, for example, be an EU manufacturer or importer.

However, non-EU companies cannot function as economic operators, and therefore need an authorised representative (EU AR) that is established in the EU.

In this guide, we explain how this works in practice and what the consequences can be if you don’t have an authorised representative.

Related Articles

1. Authorised Representatives under the General Product Safety Regulation

2. List of European Authorised Representative Companies 2025

3. Responsible Persons under the General Product Safety Regulation

Note 1: This guide does not cover authorised representative requirements concerning medical devices. We have a separate article on this topic here.

Note 2: This article was updated to reflect the fact that the GPSR now extends the EU Authorised Representative requirements to other consumer products. When this guide was initially published, this was only the case for products that required CE marking.

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Packaging and Packaging Waste Regulation (PPWR): An Overview

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Packaging and Packaging Waste Regulation

The Packaging and Packaging Waste Regulation (EU) 2025/40 establishes requirements for packaging and packaging waste sold in the European Union.

This guide explains what manufacturers and importers need to know about the scope and the requirements of the regulation. This includes, substance restrictions, EPR, labelling, documentation, and more. You will also find a comparison with the requirements of the old Packaging and Packaging Waste Directive.
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Food Contact Materials Regulations in the European Union: An Overview

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Food contact materials and articles imported or manufactured in the European Union are subject to various regulations. These regulations, wihch are often collectively referred to as Food Contact Materials (FCM) regulations, cover substance restrictions, documntation, labelling, testing and other requirements.

In this guide, we list many of the key EU FCM regulations and explain when these are relevant, and break down many of their respective requirements.
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