CE CERTIFICATION

INTRODUCTION

CE Certification: The CE stands for Conformite Europeenne, which means European Conformity. The CE mark aims to ensure that only safe, faultless, and high-quality goods are offered in the European market. CE marking is required for many products sold in the EEA (EU plus Iceland, Lichtenstein, and Norway). CE marking verifies that your product has been tested and fulfills EU safety, health, and environmental protection standards. It applies to products manufactured both inside and outside the EEA and then sold within the EEA.
To receive the CE certification on your product, you'll need to put up a technical dossier demonstrating that it meets all of the EU's regulations. As the manufacturer of the goods, you are solely responsible for declaring compliance with all standards. Once your product has received the CE mark, you may be required to give all CE-related documents to your distributors and/or importers.

CE Certification or Marking is only required for products that meet EU criteria and are marked with the CE symbol. The initials CE on commercial products indicate that the maker or importer certifies that the product complies with European wellbeing, protection, and ecological protection regulations. It is not a certification and it does not indicate the quality of the product. Its main purpose is just to sell the products in European Economic Area (EEA) freely.

Documents Required for CE Certification

How to obtain CE Marking?

1. Identify EU Requirement - The first step to get CE Mark is to decide which product and model are certified with a CE mark. And also identify the European requirements, does product meet EU requirements or not.


2. The product meets Specific Requirements - After identifying the EU Requirements, the next step is to check whether products meet specific requirements or not, which are mandatory for the CE Mark, and also identify the directives applicable and harmonic standards applicable for the product. Some of the directives are a medical device, machinery device, toy, low voltage, LVD, etc.


3. Product Test - Once the product fulfills all the requirements, the product needs to be tested (in-house/outside) according to the directive and standard requirement.


4. Compile the technical dossier - Prepare the Technical construction file of the product, which is to be CE marked, and forward it to the certification agency involved in CE Registration/certification.

At last, affix the CE marking and draft a declaration of conformity.

Note: Self-certification allows some products to be CE marked. This isn't the case with every product, either. Some products require the involvement of a CE mark notification agency/competent entity to be marked. When self-declaration is not an option, CE marking certification/registration organizations must be consulted from the beginning of the product design process.

MINIMAL RISK

Options for products with minimal risk include self certification where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product.

Many directives require products/systems with greater risks to be independently certified; this must be done by a "Notified Body". This is an organization that has been nominated by a Member Government and has been notified by the European Commission. Notified bodies serve as independent test labs and perform the steps called out by directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. Notified bodies may be a private sector organization or a government agency. Manufacturers may choose a notified body in any member state of the European Union.