CE mark- Conformity Europeene | Procedure | Unilex
What is CE marking?
The term CE stands for Conformity Europeene. If a product contains this mark it implies that it is meeting with all appropriate provisions of the relevant legislation implementing certain Europeans Directives. CE marking gives companies easier access to the European market to sell their products without adaptation or rechecking. A manufacturer who has gone through the conformity assessment process, mat affix the CE marking to the product. With the CE marking, the product may be marketed in European market. You can also understand about the CE marking this way, it is a deceleration by manufacturers that the products they are selling in EEA are meeting the requirements of the EC Directives. The benefits of the CE certification is that is a legal requirement to trade your device in the European market.
The CE mark, which affixed to a product or its packaging, is considered proof that a product has met the requirements of the European market. It is not a quality mark for consumers, intended for members state authorities. It is a visible sign on a product indicates the method of conformity assessment to bring the product into compliance. It is a conformity mark which all medical devices must have before they can be marketed. It is seen as deceleration by the manufacture that the product meets all the provisions of the relevant
Unilex Business Consultant will assist you regarding CE marking registration process. Our consultants have years of experience in generating request for CE certifications on behalf of the clients. So, if you want to export to your product in the Europen market and facing trouble due to not having CE marking on the product, then without thinking much, feel free to contact us. We are one of the leading CE marking consultant companies, whose sole objective to support clients with respect to quality standard certifications.
Documents are required for CE marking:
- A general description of the product.
- Overall drawing of the product.
- Copy of the risk assessment.
- A list of standards and other technical documentation that have been applied of the confrimity process.
- Copies of technical reports detailing any assessments carried out.
- A copy of instructions for the safe to use the product.
- A copy of the manufacturer's declaration.
Process for CE Marking Certification:
Contact consultant: Feel free to contact to CE marking consultant, Unilex Business Consultant will help you regarding CE marking certification process.
Choose a plan: Choose the plan that perfectly matches your requirements. Usually, all our prices are transparent. Our consultants are readily available to assist you regarding CE marking registration process.
Get a list of the documents: Unilex Business Consultant will be emailing you all the mandatory documents and procedures to get the CE marking certification. You are required to send you documents at the same email.
Process: As soon as Unilex Business Consultant receives documents they will send the same to the assessment of the product.
Payment: Once we receive your documents. Complete the relevant process as required and payment as well as so that we can proceed your application right away after that.
Get the CE mark: You will get the CE mark certification and other relevant things at your email. Now you can export your product in the Europe market effortlessly.
Advantages of CE Marking:
The great benefit for manufacturers is that there is now only one set of the requirements and procedure to comply with in designing and manufacturing a product for the entire EEA.
The various conflicting and regulation has been eliminated after CE marking.
The product is no longer needs to be adapted to the specific requirements of the different members state of EEA.
The product which contain CE mark is seems to be safer for the consumers and highly reputable in the market.
Now manufactures easily export their products without facing any quality standard issues.
The business growth can be easily expanded after getting CE marking certification.
Boost your sales in the Europe market and gives you returns of investment.
Frequently asked questions:
Q1 What are the general principle of the CE marking?
Only manufacturer or authorized representative shall affix the CE marking.
The CE marking shall be affixed only to products to which its affixing is provided by the specific community harmonization legislation, and shall not affixed to any other products.
The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant community harmonization legislation providing for its affixing.
The CE mark, which is affixed in the product packaging, is considered proof that a product has met the requirements of the EU market.
The affixing to a product markings, sign, or inspections which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking can be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby imparid.
Q2 What happens if a product fails to comply with all the CE marking requirements?
The manufacturer uses the CE marking to indicate that a device complies with the essential requirements established in the applicable community derivatives. Therefore, if the product is not a complaint, they cannot be put on the market. For control purposes, the Government sets annual inspection plan, aimed at establishing fines, removing from the market, or blocking the circulation that endanger the safety or health of the people, good or environment, but in all Spain and other EU member states.
Q3 Which countries requires CE marking?
The countries that require CE marking are the 31 countries in the European Economic Area. This include- All of the 28 member states: Australia, Belgium, Bulgaria, Croatia, Cyprus, Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and Uk.
Three members of the European Free Trade Association: iceland, Liechtenstein, Norway.
Q4 What are the products covered by the CE marking requirements?
CE marking is not required for all the products. However, it does apply to a large number of goods, such as electronics, toys, machinery, medical devices, and vehicles as well as all contruction goods.