CE Certification

CE stands for European Conformity. This certification works as a proof of mark affixed on the product which reflects health, safety, and climate protection standards of products sold within the European Economic Area (EEA).

There are specific procedures for the manufacturers of obtaining a CE Certificate. We must take note that CE Marking has been introduced for certain product groups, many products require a CE Certificate before being offered to consumers in European Union countries and European Economic Area countries.

The CE mark can also be developed on products that are sold outside the EEA that are produced in or designed to be sold in EEA. The CE marking signifies that the manufacturer has fulfilled all the details of the applicable EC directives. The manufacturers make sure that the EC marked goods comply with all the requisite standards.

CE Certification is only mandatory for products for which EU specifications exist and needs the affixing of CE marking. Some products are subject to several EU requirements at the same time. Also, before affixing the CE marking to it, make sure that your product complies with all the relevant requirements. It is impermissible to affix the CE marking to products for which-

  • EU specifications do not exist or,
  • The products do not require the affixing of CE marking.

What are the Benefits of CE Certification?

The benefits of getting CE Certification are given below, which are as follows:-

  • Helps in maximizing the trust and safety of the consumers
  • CE Certification is a kind of business transport for the European marketplace.
  • CE Certification allows the manufacturer to circulate their products throughout the countries of the EEA without any restrictions.
  • Prevention of imprudent accusations.
  • CE Certification acts as technical evidence in case of litigation.
  • CE signifies that the product sold in the EEA has been assessed to meet high safety, health, and environmental protection criteria.
  • The manufacturer has to comply with only one set of requirements and procedures within the designing and manufacturing process for the entire EEA.

What Documents are Required for CE Certification?

CE Certification requires technical documentation that should include at least the following detail, which are as follows:-

  • Name and address of the manufacturer, or the authorized representatives of the manufacturer.
  • Particulars of the product
  • Detailing of the product.
  • Particulars of the facilities involved in the design and manufacture of the product.
  • Particulars of the Notified body involved in evaluating the conformity of the product.
  • A statement of the Conformity assessment procedure that has been followed.
  • Particulars of Declaration of conformity
  • Label and directions of use.
  • Particulars of relevant regulations to which the product complies,
  • Identification of technical standards with which compliance is claimed,
  • Test outcomes

What is the Registration Procedure for getting CE Certification?

Getting CE Certification Involves Four Main Elements:

Step By Step Procedure To Get The CE Certification

  • 1

    Step-1

    The first step is to ascertain the requirements of the product in terms of European Union directives. The applicable directives set out the basic requirements that products must meet.

  • 2

    Step-2

    The next step is to determine whether the product meets specific requirements. This responsibility lies on the manufacturer to determine whether the products meet the requirements of the relevant European Union directive or not.

  • 3

    Step-3

    The third step is to have the product tested and approved by a notified body. However, it does not apply to all products. For some products, it is essential to verify that the product meets certain technical requirements from specific conformity assessment bodies.

  • 4

    Step-4

    Additionally, if the product does not need to be verified by an independent organization or laboratory, manufacturers may request testing from an unbiased and independent competent authority to check compliance.

  • 5

    Step-5

    Once the testing and verification is done, the next step is to prepare the technical file. The Technical file includes-

    • Technical documentation related to the product.
    • Guidance notes for manufacturers of Class I Medical Device.
    • Guidance on NB tasks of technical Documentation Assessment on a representative basis.
    • Summary of Technical Documentation for Demonstrating Conformity of the Essential Principals of Safety and Performance of product.
  • 6

    Step-6

    The last step is to prepare a Declaration of conformity and to place the CE Mark on the product. The declaration of conformity must be prepared by the manufacturer and must indicate that the product meets all relevant legal requirements.

  • 7

    Step-7

    Appoint a European Authorized Representative: - Brand owners who are sitting outside the border are obliged to appoint European Authorized Representatives. They ensure compliances before entry into the market. They also serve as an ongoing vigilance contact point to provide the manufacturer with the regulations updates as the law evolves for as long as the products remain available.

  • 8

    Step-8

    Affix the CE certification-Once the CE certification is your product gets affix, then you are free to circulate it throughout the world.

What are the Penalties in case of Non-compliance in Selling the Products in EEA?

There is no specific penalty, but in extreme, the Notified authority can cancel the manufacturer’s certificate, at the point where it would become illegal to sell CE-marked products.

What are the Types of CE Marking?

The Manufacturer or authorized representative of the product affixes CE marking to the product. CE marking is given when the product successfully meets all the CE requirements only.

Minimal Risks

A minimal risk product requires a self-declaration along with the Declaration of Conformity from the hand of the manufacturer for affixing CE marking to their product.

Greater Risks

Directives say that the products which revolve around a greater degree of risk should independently get their product certified through a notified body. European Commission notifies such a body that has all the necessary information to meet the requirements outlined in the directives.

Does a Manufacturer Need to Pay any Fees?

If a manufacturer carries out the Declaration of conformity assessment by himself, he will not have to pay any fees. However, if a manufacturer opts to use the services of a notified authority, or if the EU specifications applicable to their product that requires the independent assessment by a notified authority, then he must pay for the service,the authority provides.

The cost of CE Certification depends on the certification procedure that applies to your product and the complexity of the product etc