How Manufacturing Units in India can obtain CE Approval to sell in the Europe?

The regulating authority which is responsible for authenticating the quality of every listed product in Europe is the EEA which stands for t

Introduction:

The regulating authority which is responsible for authenticating the quality of every listed product in Europe is the EEA which stands for the European Economic Area. The products produced in the European Economic Area must mandatorily acquire the CE mark certification to ascertain its authenticity Importers as well as manufacturers of goods must be able to ascertain the quality and standard of the CE marked product through this means. CE stands for Conformitè Europëenne (CE) which is a mark Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. This marking is basically a manufacturer’s declaration that the products manufactured by him comply with the EU’s New Approach Directives. These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold within the EEA. This ensures that the CE marking is recognized all over the world.

A CE Mark is a symbol which must be affixed to most of the products prior to being sold in the European market. The mark indicates that the product accomplishes the following:-

  • Complies with the requirements of the relevant European product directives.
  • Meets every requirement of the recognized European harmonized performance and safety standards.
  • Is fit for the purpose it states and shall not endanger any lives or property through its usage.

The CE marking further indicates that several appropriate technical documentation supporting the use of the mark is available and therefore can be provided by the manufacturer, importer, or the person responsible for placing the product on the EU market.
 
Steps required to register products with the CE marking in India:

The following steps are necessary for any manufacturer in India seeking the CE certification for the products manufactured:-
  • When applying for the CE mark, the first step is to decide firmly upon a product or a model which needs to be certified with the CE mark. This is because the process of acquiring a CE marking is specific to each product or model respectively. Meaning, the marking process of CE varies with the variation in design of the product.
  • Once the product has been decided over by the manufacturer, the second step is to identify which CE marking directives will be applicable to that specific product. Various directive names include the machinery directive, low voltage directive LVD, PED pressure equipment directive, construction machinery directive, Electromagnetic compatibility directive EMC, lift directive, toys directive and medical devices directive. The manufacturer must ascertain which one of these would be applicable to his product and design.
  • After this step, the manufacturer must ascertain which harmonic standards will be applicable to the product which requires the CE marking.
  • Thereafter, the manufacturer is required to conduct a basic risk analysis of the requirements of the directives/standards as well as the products which require the CE certification in order to comply with the requirements of the directives and standards.
  • The next step would be to simply get the product which requires the CE marking, tested whether in-house or outside as per the directions given under the Directives or the Harmonic Standards.
  • There are certain products which can be marked with the CE marking via self-certification. However, since this is not the case with every product, most products are marked with the involvement of a CE mark notification agency or a competent agency or body which provides authorised CE certification. Some products can be CE marked through self-certification.
  • For those products which cannot be marked through self-certification, the CE marking and registration agencies are required to be involved from the very beginning when the designing of the product in itself begins. Hence, it is important to check whether the products must be tested by Notified Body. If so, the next step is to 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”.
  • Thereafter, post the preparation of the TFT (Technical Construction File) for the product which is thereby being marked with the CE marking, it is further forwarded to the certification agency which is involved in the acquisition of the CE certification and registration. This is done so for the final review prior to being marked with the CE marking.

Affixing of the CE Marking

After the manufacturer has complied with the respective EU legislation, the next step involves affixing the CE marking on the product itself. Certain rules which need to be complied with for affixing this mark, are given below:-
  • The CE mark must be affixed prior to product placement i.e, before the product is placed in the markets for sale.
  • The CE mark must be easily accessible for all parties. 
  • The CE mark can be affixed on the back or the underside of the product but with a minimum height of 5mm in order to ensure that the mark is legible and readable.
  • For small devices and components, the minimum dimension of the CE mark may be waived if found necessary.
  • The organizations responsible for affixing this mark must ensure that the CE mark cannot be removed under normal circumstances without leaving any noticeable mark or any proof of being tampered with. The mark should be placed in a strong enough manner to make it impossible for a normal person to remove it through normal means.

Agencies which grant CE certification in India:

There are several agencies which can provide a CE certification. However one of the most trusted sources is TUV India Partners.

TUV India Partners’ product certifications facilitate further strategic positioning of the intended product within the European market and is a trusted agency which complies with all the directives for providing manufacturers with the required CE marking.

Moreover, TÜV India has a lot of experience and knowledge with regards to international networking. This agency has partnered with TÜV NORD in order to provide the certification of a CE mark required for sale of products within the European Union.

CE is the basic standard required for French Conformité Européenne and is primarily an entry ticket for products which are intended to be sold within the European market. The mark signifies a trustworthy certification of safety and compliance with standards and thus attracts greater sales for the product as well.

TUV India, being a notified body of the European Union, assists manufacturers in acquiring compliance testing requirements within a domain regulated by EC. This agency is a one stop destination for all services pertaining to sale of a product within the European Union after acquiring the CE certification. The important aspects of assessment for acquiring this marking are provided below:-
  • Type approval testing
  • Compatibility tests such as electromagnetic, biological compatibility etc.
  • Safety tests within TUV India’s testing laboratories
  • Examination of product design by experts within the agency.
  • Preparation of expert appraisal reports by experts within the agency.
  • Certification of quality systems by the agency.

This agency is responsible for single handedly assisting organizations from as early as the developmental stage of the product. It accomplishes this by answering every doubt or question in relation to application of the regulations, occupational safety as well as health provisions in connection with the equipment’s safety.

The Agency is located at 801, Raheja Plaza-1, L.B.S Marg, Ghatkopar (W), Mumbai, 400 086, India.
It can also be accessed through the number: +91(0)22 66477000.

Requirement of fees or other obligations:

In case the manufacturer of the product carries out the necessary conformity assessment by himself, then there is no requirement of any fees to be paid. However, if the manufacturer has undertaken the assistance or services of any notified body for acquiring the CE marking or if the rules under the EU directives require the product to be independently assessed by a notified body, then the manufacturer of the product is required to pay the requisite fee as charged by the notified body. The notified body which is authorised to provide the marking always charges a fee depending upon their policy. The cost of this service depends entirely upon the certification procedure which is applicable to the manufacturer’s product as well as the complexity of the product in itself.
 
Benefits of acquiring a CE certification:

The benefits of acquiring a CE marking can be summaries within the following points:-
  • There are numerous benefits associated with a CE marking upon a product since this marking is also a trade passport of sorts for the European marketplace overall. This mark allows the manufacturer to circulate their products freely throughout all the thirty countries within the EEA (European Economic Area).
  • One of the primary benefits at present, available to manufacturers is that currently there exists only one set of procedures and requirements in order to comply with the design and manufacture directives within the whole of EEA.
  • The several conflicting rules and national regulations pertaining to each member state have now been removes. The product thus no longer needs to be adapted to the specific requirements of the different member states making it way less cumbersome and much more simplified.
  • Furthermore, it can be stated that it is always a benefit for any product to acquire a legitimate marking like that of the CE as it renders the product trustworthy in the eyes of the target customers and in the long run it may also imply lower damage and liability claims over any issues which may arise.