Certification Mark

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Certification Mark


The certification mark is a specialized type of trademark that is used for indicating that certain goods or services have met certain prescribed standards. A certification mark can be represented by names, symbols, marks, etc for goods and services, and it does not differ between either of them.

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C E Certification mark:

  • Conformite Europeenne (CE) which means “European conformity” is a European Union (EU) conformity that is marked on the products, which complies with the requirements of European health, safety, and environmental protection standards, which are also called product directives.
  • The CE certification should be mentioned on the goods or products sold within the European Economic Area (EEA), as it represents the manufacturer’s declaration on the products, which comply with the EU directives.
  • The directives mandated are not only applied to products within the EU but also for the products manufactured or sold in the EEA.
  • The CE mark imprinted on products indicates that appropriate technical documentation will be provided by the manufacturer or importer for supporting the use of marks.
  • Importantly, the CE marking on products does not enclose any specific information to the consumer, and similarly, the marking is not a quality assurance declaration as there is no evidence of third-party testing.
  • But certain directives have provided the organization to declare the conformity stating that if challenges arise over products, supporting evidence should be given to counteract the claim.
  • The directives concerning the products related to health or safety will require an appropriate certificate, from the recognized body to support the self-declaration claim.
  • The products which do not comply with the provision mandated by the product directives are barred to enter or circulate inside the EU zone, i.e member states.
  • If any products are sold against the principle of the directives, appropriate action will be taken to curb products from being sold and used.

CE certification for medical devices:

  • CE certification of medical devices is mandatory if they are to be commercialized in the EU. The CE marking indicates that the medical device complies with the requirements of the Medical Device Regulation (MDR), which was introduced in May 2017, by replacing previous Medical Device Directives (MDD) and integrating Active Implantable Medical Devices (AIMD). The CE certification can only be used if the medical devices have passed the conformity assessment test.
  • The essential requirements for CE certification for medical devices are
    • It should be appropriate for the intended use.
    • Safety elements.
    • Methods of transportation and storage.
    • Risks and benefits.
    • Labeling and specification.
  • The CE certificate should be obtained based on various classes for medical devices, like the class I ( non-sterile, non-measuring), class II ( sterile, measuring), class II(a), class II(b), class III.

Procedure to obtain CE certification in medical devices:

The new MDR 2017/745 will come into effect in May 2020, by which all manufacturers who have been following MDD and AIMD should switch to this new regulation. The procedure to obtain the CE certification under new MDR are as follows;

Classify the medical device:

Initially, the manufacturer should classify the medical device by determining the set of regulation that applies to the device subject to Medical Device Regulation ( MDR 2017 / 745) or In Vitro Diagnostics Regulation (IVD 2017 / 746). Annexure VIII of the MDR will classify the medical device depending upon the risk factor. Here the classification pertains to the time scale of contact with patients, a degree of the meddling of the device, and its effect on different parts of the human body, by use of this device.

Organize a Quality Management System (QMS) to govern the medical device:

The QMS is an essential and global requirement to enter into the medical device sector. The European Commission has sorted out the QMS for medical devices, which is required to enter into the EU market. The quality management system will consist of the procedure and policies that should be carried out by the workers daily to ensure the manufacturing processes are safe and reliable.

Conformity requirements:

Once the classification of the medical device and enforcing the QMS at the organization is over, the next best thing is for the device to meet the conformity requirements of the MDR. Depending on medical device classes like the class I, class IIa, class IIb, class III, the technical file should be produced concerning the conformity of the medical device. This technical file includes;

  • Description of the product.
  • Manufacturing unit.
  • Documents regarding risk management.
  • Approved design and validation test reports.
  • Labeling.
  • clinical assessment.

The class III device should enclose the illustration about the design of the product along with this technical file.

Conduct an audit by the notified body:

Once the above procedure has been accomplished, the QMS and documentation of the organization will be audited by the notified body. The notified body is a third party body, which conducts the audit of medical device manufacturing companies and certifies that the medical device produced by them meets the standards required by the MDR/ IVDR.

Declaration of conformity:

After the medical device has passed the audit, the CE certification will be issued to the product along with the ISO 13485 certification, which confirms that the QMS complies with the European standards. Finally, the declaration of conformity, which is a legal document proclaims that the medical device meets all the required standards by the MDR/ IVDR and that the CE certification can be affixed to the medical device.

Benefits of CE certification


Business advantage:

As the CE certification is a well-known certification mark among the public, the organization, which mentions the CE certification mark on products, will have an additional advantage to conduct business without facing any restrictions on the European Economic Area (EEA).

Reliable products:

The CE certification will ensure consumers that the products are tested, and are reliable, concerning manufacturing, customer safety, quality, etc.

Hassle-free regulations:

The manufacturers need not worry about too many restrictions, such as the CE certification mark, is the only standard requirement. By following the product directives, it is easy to apply and achieve conformity.

Option for self-assessment:

Apart from the standards required by the product directives of the EU, some appropriate directives can be self-declared by the manufacturer for conformity, which should not contradict with the EU directives.

Decreased damages in the products:

By carrying out the regulations prescribed by the EU, there will be very reduced damages and errors in the product thereby the liability of the manufacturer will be decreased in the European market.

Easy market access:

Any manufacturer from the world can make or sell his/her products inside the European Economic Area (EEA) after meeting the prescribed standards of the EU product directives. As the CE mark is the only certification required by the European market, the manufacturer will not face any hurdles in obtaining the certification. The certification mark imprinted on products ensures consumers that the respected goods fulfill the standards required by certifying authority or organization.

The factors indicated by a certification mark are as follows;

  • The geographical indication of goods or services, i.e the place of origin of the commodity. Eg: If the product is a bag of potato chips, then the certification mark will show that the potato was grown in the respective place, providing authenticity and uniqueness to the product or service.
  • Similarly, the CE mark will specify the characteristics of goods or services concerning quality, safety, morality, manufacturing unit, materials engaged with the products, etc. For example An agmark certification indicates that various products like milk, wheat, vegetable oils have been tested, thus providing quality assurance.
  • It explains the working conditions under which the goods have been produced.
  • It shows the labor, who has engaged with the production of goods or services, has met certain quality or skill standards and whether it belongs to any labor union organization.
  • By acquiring the certification mark, the product can show its uniqueness in the market, and it promotes the reputation of the brand.
  • The certifying organization determines who should use the certification mark. The owner of the certifying organization cannot use his/her certification mark on goods or services, rather it is used by the service provider, who had attained the standards of the certifying organization.
  • Ex: Energy star is a certification mark used to mark the efficiency of the products concerning its performance, like energy consumption, greenhouse gas emissions, etc. Energy star is governed by the Environmental Protection Agency (EPA), which sets the standards for awarding the energy star certification. Based on that, the energy star made a score of at least 75, which should be secured by-products to obtain this certification. Now, the brand Life's Good (LG), which produces a lot of electronic equipment like TV, refrigerator, etc. has acquired the energy star rating for their various products by meeting the standards required by EPA. Here, the EPA is not supplying any of these products, it is just a certifying authority that certifies LG products have been tested and it has met the standard requirements of the EPA.
  • LG products will represent its trademark logo and the certification mark of the Energy Star. These two marks will provide different information with a different perspective on the consumer, who purchases these LG products. So it’s clear that the EPA owns the energy star certification and LG company uses this energy star certification in their products, if it meets the EPA standards.
  • Initially, the request should be made by the LG to test their product, to ensure that it has attained the prescribed standard of the EPA. If LG has scored the required level of certification, then the certification mark will be stamped on that product, thereby acknowledging to the consumer that the required level of efficiency has been met by the product.

Checklist requirements of a CE certification mark

As the CE marking is proof that the product meets the high safety, health, and environmental protection standards set by the EU. The importer should ensure that the product has the correct CE certification mark or not. It is irrespective that the product was manufactured inside or outside the EEA, if the wrong or fake CE certification has been imprinted on the product then it is considered as an offense and subject to punishment. Hence, a checklist will help in sorting out the most important things.


Analyze the EU directives and the standards apply:

According to the EU legislation, the EU directives have separate directives for each product group and various classes, more than one directives can be placed for the same product group. For instance, electrical products fall under the EMC, and RoHS directives.

Check the conformity of the product:

The manufacturer is accountable for testing the products and checking the essential requirements of the directives that should be met. Most importantly, the risk assessment should be executed in the above procedure.

Produce proper technical documentation:

The technical documentation will be scrutinized by the market authority if required. Here, the technical documentation includes specification, inspection certificates, drawings, test reports, manuals and the declaration of conformity. If products are imported from outside the EEA, then the importer should make sure that the foreign manufacturer must produce the technical documentation of the product, if requested, by market authorities. Similarly, the manuals should be written in the language where the product is sold.

Enclose the declaration of conformity:

The manufacturer should ensure that the CE mark is mentioned on the products after the assessment process is over. If the notified body has conducted the production phase, then the corresponding body’s identification number should be mentioned on the products. Finally, the declaration of conformity should be signed thereby taking the responsibility for the conformity of the products and should be included in the technical documentation. For some product groups, this proof of declaration should be enclosed while supplying the products to customers.

Famous Certification marks

AGMARK:

The AGMARK is a quality certification mark and it ensures the quality and purity of agricultural products. The directorate of marketing and inspection impose the agricultural produce act, 1937, which prescribes the standards met by the agricultural products to obtain the AGMARK certification. These standards are harmonized with international standards by interpreting WTO requirements. Products which comes under the AGMARK certification are;

  • Vegetable oils.
  • pulses.
  • Spices.
  • Wheat products.
  • Cereals.
  • Honey, rice, etc

ISI Mark:

ISI stands for the Indian Standards Institute, which was established to create a standard and to maintain the quality of the industrial product production. This certification mark ensures that the products have met the standards determined by the ISI. Nowadays, this certification is issued by the Bureau of Indian Standards (BIS) concerning the legislation of 1986. The ISI mark can be obtained mandatorily and voluntarily. However, certain products are mandatory to obtain the ISI mark! They are LPG cylinder, fertilizers, packaged drinking water, electrical appliances, steel products, cement, batteries, etc.

BIS Hallmark:

The BIS Hallmark certification denotes the purity of the gold and silver in India. This mark was introduced in the year 2000 for gold and 2005 for silver. Recently in January 2020, the ministry of consumer affairs mandated that all jewelry makers are to acquire the BIS hallmark certification on gold jewelry, within a year’s time i.e by 2021. The objective of mandatory hallmarking is to protect the consumer from being cheated by the manufacturer and obligating the manufacturer to maintain the standards of purity.

CE marked products:

The CE certification should be marked on the following products

  • Medical devices
  • Measuring instruments
  • Machinery
  • Pressure equipment
  • Lifts
  • Safety of toys
  • Construction products
  • Electromagnetic compatibility.
  • Gaseous fuels
  • Pressure vessels.
  • In vitro diagnostic medical devices.
  • Pyrotechnics.
  • Electrical appliances.
  • Recreational crafts.
  • Hot water boilers.
  • Mobile chargers.
  • Household refrigerator, etc.

Procedure for obtaining the CE mark:


Identify the applicable directives:

The first and foremost step is to identify whether a product is eligible to obtain the CE certification or not. The reason is not all products are obliged to receive the CE mark. Certain selected products fall under the scope of any EU product directives and hence required to affix the CE mark.

Point out the requirements of the directives:

Each directive has a unique essential requirement that has to be met by the product and it depends upon the classification of the products. These essential requirements are in par with the Harmonised European Norms (HENs).

Conformity assessment procedure:

There are different conformity assessment modules sorted out by the directives for each product. The various modules available are

  • Module A: Internal production control.
  • Module B: EC type-examination.
  • Module C: Conformity.
  • Module D: Quality assurance on production.
  • Module E: Quality assurance on the product.
  • Module F: Verification of quality.
  • Module G: Unit verification.

Self- certification and notified body certification:

The products having minimal risk can be self-certified by the manufacturer by enclosing the declaration of conformity. But the products with greater risks are to be independently certified by the notified body, which may be a private sector organization or government body nominated by the member government.

The notified body follows the procedure laid down by the product directives and performs all tests on independent labs. The manufacturer can choose a notified body, which is enlisted in the official journal published by the European Commission.

The notified body performs the following functions:

  • Testing the products.
  • Technical document and design dossier evaluation.
  • Issuing the type-examination certificate
  • Monitoring the quality of the product.
  • Standards identification.

Similarly, a certain set of directives require the manufacturer to assign the authorized representative in the European Union to produce the technical documentation.

Prepare the Technical Construction File (TCF):

The product directives mandate the manufacturer to prepare the technical documentation of the products. This document contains information related to test reports and compliance standards of the products.

Prepare the declaration of conformity and affix the CE marking:

The manufacturer, importer, and authorized representative should enclose the declaration of conformity of the products once they are satisfied that their products comply with the standards of the directives. Some products are required to be registered in the EU ex: class I medical devices. Without this registration, these products are not allowed to affix the CE mark. After the aforementioned process is over, affix the CE mark on the product and provide them in the market for sale.

Documents required for obtaining the CE certification

The documents required for obtaining CE certification mostly include the technical documentation and declaration of conformity of the manufacturer.


Technical Construction File (TCF):

  • A basic elucidation of the product.
  • The visionary design, drawing, and schemes of the components, circuits, etc.
  • Proper representation and interpretation should be present for understanding these designs and drawings.
  • A report of risk assessment, which shows the steps to be taken for mitigating those risks.
  • A copy of conformity documentation for critical components of products.
  • Test reports
  • The instructions and manual for safe use of the products.
  • Results regarding the examination carried out by the notified body.

Declaration of conformity:

  • The Name and address of the manufacturer
  • Description of the product concerning the model, serial number, etc.
  • A set of product directives and standards applied.
  • The declaration statement on the products, which comply with the requirements of directives.
  • Details of the authorized representative of the EU.
  • A name, signature, and position of the executive person.
  • The appropriate date of the declaration, which was signed.
  • Additional directives added by the manufacturer.

Frequently asked questions

These are bodies approved by the member state of the EU to conduct third-party conformity assessment. The notified body assessment procedure is not required for all products, only certain directives mandate that the products are to have an independent audit. The set of notified bodies can be found out in the New Approach Notified and Designated Organization (NANDO) website.
The cost for CE certification will vary depending on the products, which fall under different directives. The cost includes the cost for testing, notified body fees, consultant fees for preparing the technical documentation, an annual audit conducted by third-parties.

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