Getting a certified product or safe product is a right and wish of every customer around the world. CE is kind of certification mark on the products that are related to health, safety, and environment. It is originated in Europe. In Europe, there is a regulating authority called the EEA that means the European Economic Area. The EEA authenticates the quality of their listed products. Products located within the European Economic Area have to mandatorily obtain CE marking certification. Importers, as well as the manufacturer of the goods, need to ascertain that EC marked goods are up to the standards. Today, in this article we will tell you about the basic of CE Marking Certification, How to get CE marking Certification, and the kinds of the CE Marking Certification. The EEA is bundled with European Countries like Iceland, Liechtenstein, and Norway. It is also considered as the EEA single market. CE stands for the “Conformite Europeenne.” The literal meaning of the CE is the European Conformity but later it changed it to CE mark in 1993. The products which are exported to EEA by the other countries can also have the CE marking as the EEA standards is a sign of guarantee.
The Logo has a substantial value of a standard on which people trusts and to make that trust more strong the CE technical experts is matching step by step with the changing trends of different products and making it more competitive to pass the level. They also act as an advisory to the manufacturers. CE is a standard of the international standard because many products are sold outside the EEA.
The CE Marking is one of the finest and most acknowledged standards that is brought forth by EEA and permits the manufacturer to use the mark to lighten the standard. Now, ISO Certification is an International non- government organization that independently controls or manages the quality management system with some standard. The ISO mark silently changes the mind of the customer from not trusting a product to trust the product after the ISO mark. It also increases the value and trust in the product. There is no mandatory or necessary rope attached to the product to get this certification but it just makes a product of minimum standard to a high standard after theISO mark
The European Commission lifts the curtain from the harmonized conformity with the EU EMC that puts all their attention in checking the quality, safety and non- health hazardous substance in the products. The EC made CE marking mandatory stamp for the production of electronic and electrical equipment that is sold in EEA. This made a particular standard of the above equipment safe and ready to use and make the product less harmful to the mankind of the users.
Well, the procedure involves a series of steps that are outlined below. The procedure may get different depending on the product and the nature of the risks it presents
Check what kinds of directives are applied to your product first. If in case you have more than one directive then you have to apply for all of them. Following are some of the examples- Electrical equipment Machinery Toys Medical devices Lifts Personal Protective Equipment
Determine the extent to which your product complies with the essentials requirements for design and manufacturing in the applicable directives.
Select the conformity assessment procedures from the options that are available by the directive for your product. The Directives often use a series of questions about the nature of the product to classifies the level of the risk and refer to a chart called “Conformity Assessment Procedure”. Not only this, the chart includes all the acceptable options available to a manufacturer to certify their product and affix the CE marking.
Collection of documents from Indian importer.
Select the applicable products standards and test method for your product standards as per the notified body. Establish an Authorized Representatives in the European Union for your product
The technical dossier should include all the required documents that will help to prove that the product has compiled all the technical requirements.
The following are the necessary areas of the conformity assessment which includes as described-
As CDSCO registration consultants, our job is to ensure that the tiring procedures that we have listed above become a cake-walk for you. Right from the beginning i.e. from the stage of collection of documents from the foreign manufacturers or preparation of documents for the Indian manufacturer and following up with the department for grant of license is under our scope.
We are one of the most experienced CDSCO consultants in the field of medical products,we provide apex quality of services possible to all our national and international clients.