Tag: compliance eu

Market Surveillance Regulation: An Essential Guide

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Market Surveillance Regulation
The Market Surveillance Regulation aims at ensuring that products sold to consumers are safe and prevents general non-compliance.

For some categories of products, toys and electronics for example, it sets certain tasks that must be performed by manufacturers – or their authorised representative, in the case of non-EU manufacturers that sell to consumers in the EU, – and other economic operators.

In this guide, we explain what the requirements of the Market Surveillance Regulation are, what products it covers, and elaborate on its impact on manufacturers, importers, and other economic operators from both EU and non-EU countries. This includes businesses based in the United Kingdom.
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EU Medical Device Classes Guide – Class I, IIa, IIb, and III

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EU Medical Device Classes Guide - I, IIa, IIb, and IIIThe Medical Devices Regulation sets requirements according to device class. More specifically, medical devices are defined as class I, IIa, IIb, or III. In turn, this determines certain requirements, and which conformity assessment procedure the manufacturer must follow.

In this guide, we present the different classes for medical devices, explain how medical devices must be classified, delve into the classification rules, and explore the implications of each classification.

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Medical Devices Regulation: An Essential Guide

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Medical Devices Regulation: An Essential Guide
The Medical Devices Regulation (MDR) regulates medical devices and their accessories manufactured or imported for the European Union market.

This guide provides examples of products covered by the Medical Devices Regulation, explains which medical devices require a notified body, and elaborates on various requirements for such products including documentation, labelling, and testing.
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Products covered by the Medical Devices Regulation: An Overview

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Products covered by the Medical Devices Regulation: An Overview

The Medical Devices Regulation covers both products that have a medical purpose, and products without an intended medical purpose – for example coloured non-corrective contact lenses. Additionally, medical devices are divided into different classes, according the risk level. Hence, the requirements vary depending on the class of the device.

It is therefore important to understand if your product is covered by the Medical Devices Regulation and, if so, under which class it belongs.

In this guide, we list examples of products covered by regulation, ordering them by type (e.g. invasive devices), and class (e.g. Class I).

Product List Creation Methodology

1. The product examples listed in this guide are taken from section “4.2 General explanation of rules/practical issues/examples” of the “Guidance on classification of medical devices” that is available on this Guidance page.

a. The product categories listed in this guide (e.g. Non-invasive devices) are taken from the headlines and sub-headlines available in section 4.2.

b. The product examples (e.g. wheelchair) are taken from the tables available in section 4.2.

c. We have sorted the products by class of medical devices (I, IIa, IIb, III), according to the information that is provided in the tables available in section 4.2.

2. The last section of this guide (Groups of products without an intended medical purpose) is an exception.

In this case, we have taken the product examples (e.g. Short-term use coloured non-corrective contact lenses) from section “4 Classification” of the “Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies” that is available on the Guidance page linked above.In

this case, the products are sorted by class, according to the information available in section 4 of the document.

3. Note that the list below is not exhaustive and only provides examples. You can consult the guidance documents for more information.
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Skincare Regulations in the European Union: A Summary

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Skincare Regulations in the European Union

This guide covers requirements for skincare products, such as body lotion and soap. While we mainly focus on the Cosmetic Products Regulation and how the regulation relates to skin care products, we also cover the REACH Regulation, POPs Regulation, and Commission Decision (EU) 2021/1870.

Methodology: We list examples of skincare products provided in Annexes II to V of the Cosmetic Products Regulation. Also, we list examples of restricted substances from the following sources:

a. Annex II of the Cosmetic Products Regulation

b. Annex III to V of the Cosmetic Products Regulation (only substances for which skincare products are specifically mentioned)

c. Commission Decision (EU) 2021/1870 establishing the EU Ecolabel criteria for cosmetic products and animal care products (only substances for skincare care products are specifically mentioned)

d. REACH Regulation

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Hair Care Regulations in the European Union: A Summary

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Hair Care Regulations in the European Union
This guide covers requirements for hair care products, such as hair sprays and hair lotions. We primarily explain the Cosmetic Products Regulation regulates substances in hair care products. We also explain the relevance of other regulations such as REACH, and the POPs Regulation in the context of hair care products.

Methodology: We provide examples of hair care products mentioned in Annexes II to V of the Cosmetic Products Regulation. Additionally, we list examples of banned and restricted substances from the following sources:

a. Annex II to V of the Cosmetic Products Regulation (only substances for which hair care products are mentioned)

b. Commission Decision (EU) 2021/1870 establishing the EU Ecolabel criteria for cosmetic products and animal care products (only substances for which hair care products are mentioned)

c. REACH Regulation

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Cosmetic Substance Restrictions in the European Union

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Cosmetic Substance Restrictions in the European Union

Cosmetics made for the EU market must comply with certain substance restrictions. Some substances are prohibited, while limits apply to others. In some cases, there are also positive substance restrictions, in the sense that only certain substances can be used.

In short, understanding the status of the substances used in your cosmetic products is essential when selling in the EU. This guide takes a closer look at these restrictions in the Cosmetic Products Regulation, REACH, and the POPs regulation.

Methodology: In this guide we provide examples of restricted substances that are relevant to cosmetics, taken from the following sources:

a. Annex II to VI and Articles 15 to 17 of the Cosmetic Products Regulation

b. REACH Regulation

c. POPs Regulation

d. Toy Safety Directive

e. Commission Decision (EU) 2021/1870 establishing the EU Ecolabel criteria for cosmetic products and animal care products

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EU Cosmetic Products Regulation: An Essential Guide

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The Cosmetic Products Regulation establishes requirements for cosmetic products in the European Union, such as makeup, hair care products, skin care products, and more. In this guide we break down the requirements of the Cosmetic Products Regulation, including substance restrictions, safety assessment, labelling, and documentation.

In addition, we also list other regulations that are relevant to cosmetics, such as the REACH regulation and CLP regulation.

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Baby Pacifier Regulations & Standards in the European Union: An Overview

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Baby pacifier

Baby pacifiers, teats, and similar products are subject to strict safety standards and substance restrictions. In this guide, we explain the main requirements of relevant regulations such as the Teats and Soothers Directive, the General Product Safety Regulation, REACH, and more.

We also explain why you should not assume that pacifiers manufactured outside the EU are designed to comply with European Union safety requirements.
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General Product Safety Regulation (GPSR): An Essential Guide

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The General Product Safety Regulation (GPSR) is a new regulation that will replace the General Product Safety Directive (GPSD). Its purpose is to set safety and other requirements for all consumer products, regardless of whether product-specific regulations, directives, or standards exist.

This is already the case with the GPSD, but the GPSR goes beyond the GPSD in some aspects. The GPSR also provides more detailed requirements, for example, in terms of product and packaging labelling.

In this guide, we help you better understand the new GPSR and the steps you must take before it finally replaces the GPSD.
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