Search Results for: medical device

Which Countries Accept CE Marked Products?

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CE mark Accepted

The European Union mandates the use of the CE marking for many product categories such as electronics, toys, medical devices, and personal protective equipment. That being said, some countries outside the EU, including Turkey and the United Kingdom, can accept the CE marking for certain products.

Other countries recognise certain aspects of the CE marking process – such as EN standards.

In this guide, we explain what you need to know about the acceptance concerning CE-marked products and EN standards in the United Kingdom, Turkey, Israel, Switzerland, Singapore, and other countries.
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List of European Authorised Representative Companies 2024

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Request a free EU Authorised Representative Quotation Here

The Market Surveillance Regulation (EU) 2019/1020 states that sellers based outside the EU selling certain products to consumers in the European Union must have an authorised representative. This authorised representative must based in the EU, and manage certain tasks within the market.

In this guide, we list companies offering authorised representative services for products covered by the Market Surveillance Regulation (EU) 2019/1020.

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List of CE Marking Service Companies: Our Top 16 Picks

Posted on by Yvette Shen — 8 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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Classification, Labelling and Packaging (CLP) Regulation: An Overview

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CLP Regulation
The Classification, Labelling and Packaging (CLP) Regulation classifies and regulates substances, mixtures and some articles in order to protect people and the environment.

The scope of the regulation also includes consumer products mainly composed of substances, such as candles, or finger paints.

In this guide, we explain how the CLP Regulation applies to those substances and products, including requirements regarding labelling, packaging, and lab testing.
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PFAS Regulations in the European Union: An Essential Guide

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Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) are a group of chemicals that have been used in certain consumer products for their ability to resist water and stains.

Such products include cookware, clothing, furniture, and building materials. In recent years, PFAS has been restricted by various regulations in the European Union because of their toxicity to humans and the environment.

In this article, we list examples of products that might contain PFAS, as well as regulations that restrict them, including REACH, the POPs Regulation, and the Cosmetic Products Regulation.
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CE Certificate of Conformity: A Complete Guide

Posted on by Fredrik Gronkvist — 29 Comments

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 suppliers.

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.

Alternative terms

Certificate of Conformity documents can have the following titles:

  • CE Certificate
  • Attestation of Conformity
  • Verification of Conformity
  • Certificate of Compliance

Some service providers also refer to these as voluntary certificates.

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What is the difference between REACH and RoHS?

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difference between REACH and RoHS

The REACH Regulation and RoHS Directive restrict the usage of various substances. There is also some overlap in terms of the substances covered by RoHS and REACH, which can create some confusion. However, they differ in terms of product scope, substance restrictions, and labelling requirements.

In this guide, we explain and summarise what some of those differences are. We also include examples of restricted substances for both regulation, and the respective limits.
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Amazon Product Compliance Document Requests and Removals

Posted on by Fredrik Gronkvist — 2 Comments

Amazon sometimes contacts sellers to request test reports, label photocopies, and product certificates, for the sake of verifying that the product is safe and fully compliant with the national regulations in the concerned marketplace. Such a review can be trigged when listing a new product, consumer complaints, or by Amazon’s own internal compliance review team.

In this guide, you will learn why Amazon requests compliance documents from sellers, and what they normally expect. We also cover real-life case studies, to demonstrate how products are subject to different types of compliance document requests. Continue reading Amazon Product Compliance Document Requests and Removals

Reese’s Law – Guide to Button Cell Battery Safety Requirements

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Reese's Law
Reese’s Law, enacted in honor of a toddler who lost her life due to the ingestion of a button cell battery, intends to protect users from similar tragedies. It mandates the establishment of a safety standard, which in turn sets requirements for button cell and coin batteries, and products that might contain such batteries.

This guide explains the background and purpose of Reese’s Law. It also covers 16 CFR Part 1263, the safety standard proposed by the CPSC as a result of the law. This guide also covers the standard’s product scope, as well as requirements regarding performance, labeling, testing, and certification.
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