CE Certification

CE Certification

CE mark is required for all products that are exported to European Union. The products which are manufactured within the EU would also require this form of conformity. Hence, if you want to export your products to the EU then you would require this form of conformity to maintain specific standards. CE certification is crucial for products which are exported to the EU.

Package inclusions:
  • Procedure for Applying for CE Certification
  • Liaising with the Regulatory Authorities for CE Certification
  • End-to- End Documentation for this form of certification
  • Approval for CE Certification
CE Certification

CE Certification- An Overview

CE Certification is also known as CE mark. CE is an abbreviation for Conformitè Europëenne (European Conformity) which is one of the mandatory requirements for products to have some form of standards related to conformity. This mark was introduced in 1985. Hence such certification would be applicable to products which are manufactured and distributed within the European Union. This would also be applicable to products which are manufactured within the European Economic Area (EEA).

Such requirement for CE Certification ensures that the products which are manufactured would comply with the requirements of specific conformity directives as required in the European Union. This directive is known as the New Approach Directive which was introduced throughout the EU by the European Commission.

This certification would not only be for products which are sold within the EU but also applicable to products which are sold in the EEA. In order to ensure specific standards related to quality, the European Commission has introduced this form of CE Certification, which would represent specific form of conformity with respect to the product.

Regulatory Authority/ Body for CE Certification (CE Mark)

The primary regulatory body or authority for CE Certification is the European Commission. The Commission has made different form of directives to apply to all EU member states. Currently there are 27 member states within the EU. Due to Brexit, the UK is no longer a member of the EU. Hence, if any product is made within the EU, then such products would have to confirm with the requirements of CE Certification. Such certification would be applicable to manufacturers, importers and exporters of products.

Who would require CE Certification?

The following would require CE Certification:

Who would require CE-Certification
  • Manufacturers

    A manufacturer within the EU would have to take this form of certification if the products are manufactured within the EU. This would also be required if the products are manufactured within the EU and sent to the EEA.

  • Importers

    Importers have to ensure that there is effective compliance with respect to the CE certification before importing any products to the EU. This would also be applicable to importers within the EEA. For example, if a medical device is imported to the EU, then such medical device would require this form of CE Mark or CE Certification. By carrying out this, the importers would ensure that they are compliant with relevant EU legislation.

  • Exporters

    Any exporter that sends products to the EU or the EEA requires to ensure that this mark is present in their product. For example an exporter of toys from India would require the CE mark to be present on the product.

What are the steps required to carry out before placing the CE mark or CE Certification on the Product?

The following steps are required to be taken before placing a CE mark on the product:

  • Manufacturers or importers have to check the relevance with respect to the particular legislation.
  • The requirements related to conformity assessment must be carried out by the manufacturer.
  • The dossier of items must be separately prepared by the manufacturer for securing the CE mark.
  • After this step is carried out the products which are within the standards related to conformity have to be declared.
  • Distributors would have to check if the products have this form of conformity or mark. Then only the products would be distributed.
  • The manufacturer or the importer has to check, if the product first falls under the category of the new approach directives. If the product or categories of products fall within the category of the new approach directives, then the manufacturer would require considering the protocols related to conformity.
  • Hence in order to consider a product for the respective CE mark there is a requirement for the product to be under the category of the New Approach Directives.

What are the types of New Approach Directives?

The following products are included in the New Approach Directives:

  • Radio equipment directive (RED) = 2014 / 53 / EU
  • Low voltage directive (LVD) = 2014 / 35 / EU
  • Electromagnetic compatibility directive (EMC) = 2014 / 30 / EU
  • Medical devices directive (MDD) = 2007 / 47 / EC
  • Directive on active implantable devices (AIMD) = 90 / 385 / EEC
  • In vitro diagnostic medical devices directive (INVMD) = 98 / 79 / EC
  • Machine directive (MD) = 2006 / 42 / EC
  • Directive on the restriction of the use of certain hazardous substances (RoHS) = 2006 / 42 / EC
  • Waste electrical and electronic equipment directive (WEEE) = 2012 / 19 / EU
  • Batteries directive (BATTERY) = 2006 / 66 / EC
  • Equipment directive for potentially explosive atmospheres (ATEX) = 2014 / 34 / EU
  • EcoDesign requirements directive for energy-related products (ECODESIGN) = 2009 / 125 / EC
  • Directive on the labelling of energy-related products (LERP) = 2010 / 30 / EU
  • Directive on packaging and packaging waste (WASTE) = 2015 / 720
  • General product safety directive (GPSD) = 2001 / 95 / EC
  • Personal protective equipment directive (PPE) = 2016 / 425 / EU
  • Toy safety directive (TOY) = 2009 / 48 / EC
  • Directive on explosives for civil use (ECU) = 2014 / 28 / EU
  • Pyrotechnic substances directive (PTA) = 2013 / 29 / EU
  • Measuring instruments directive (MID) = 2014 / 32 / EU
  • Non-automatic weighing instruments directive (NAWI) = 2014 / 31 / EU
  • Ropeway installation directive (CWI) = 2016 / 424
  • Safety components for lifts and elevators (LIFTS) = 2014 / 33 / EU
  • Directive for simple pressure vessels (SPVD) = 2014 / 29 / EU

Hence if the product comes under the above directive then the CE Certification would be required to be present on the product.

Procedure for Securing the CE Certification

There is a prescribed procedure for securing the CE certification:

Procedure for Securing the CE Certification
  • Apply for General Information
  • Identify Directive
  • Check Requirements related to product
  • Check if Independent Conformity Assessment is Required
  • Test Product
  • Keep Documentation
  • Place the CE Mark
  • Apply for General Information

    If the applicant wants to inquire about the certification process then go to the following website https://www.ceisaret.com/en/ce-belgesi-basvuru and provide details of the firm and which category of CE would the applicant be applying for.

    If the applicant wants to inquire about the certification process then go to the following website https://www.ceisaret.com/en/ce-belgesi-basvuru and provide details of the firm and which category of CE would the applicant be applying for.

  • Identify Directive

    In the next step, the applicant would have to check if there is any form of particular directive related to the CE Certification. Therefore the applicant has to first check, if the criterion meets the products. The applicant also has to make sure that the directive would be applicable to the product. If there is no form of directive applicable for the product then there is no need for the product to have a CE certification.

  • Check Requirements related to product

    Similar to the first step, the applicant would have to check the requirements related to the product.

  • Check if Independent Conformity Assessment is required

    If there is any form of independent conformity assessment, then the same has to be checked by the applicant. There has to be a separate authority for checking the requirement of independent conformity assessment as not all products require it.

  • Test Product

    This step is carried out in order to ensure that the product confirms with the requirements related to conformity. For this a risk assessment method has to be carried out to be compliant with the respective regulations.

  • Keep Documentation

    If required based on the technical requirements related to the products, specific products would have to ensure that technical evaluation or technical documentation is submitted to ensure conformity. Such documents have to be considered when putting an application.

  • Place the CE Mark

    In the last step, the CE mark or CE Certification must be placed by the manufacturer. However, in some parts it can be placed by the authorised representative.

Note: CE Certification/ CE Mark Image rules- There are specific rules related to the requirement of CE. These rules have to be followed by the manufacturer or authorised representative:

  • The initials which are CE must be clear and legible to the reader.
  • The CE must be as per the requirements in order to comply with the standards.
  • Marking must be at least 5 millimetres.
  • CE must be placed on the product or packaging and other accompanying documents.
  • The CE mark has to be legible.

Documents for CE Certification

The following documents have to be submitted for this form of certification:

  • Directive Documents
  • Product Specifications
  • Importer Identity
  • If the Manufacturer is outside the EU, then compliance must be maintained as per the rules for identification.
  • Design and Manufacturing Details of the Product
  • Address of the Manufacturing Entity and the Registered Office
  • European Community Type Examination Certificates
  • Test Report of the Product
  • Copy of the Risk Assessment
  • Declaration from the Manufacturer

How to reach Enterslice for CE Certification

Fill The Form

Get a Callback

Submit Document

Track Progress

Get Deliverables

Frequently Asked Questions

CE Certification is an abbreviation of Conformitè Europëenne. This is a French word for European Conformity. This confirmation would ensure that the standards related to products are maintained for any products which are manufactured and distributed across the European Union.

Yes this form of certification would also be applicable to the European Economic Area. Hence products which come under the conformity have to ensure that standards are maintained.

There are particular products which require this form of certification. Some of the products are:

• Medical devices

• Toys

• Radio Instruments

• Measuring Instrument

There are more than 20 directives for products which require this form of certification. Hence the manufacturer has to ensure to check the specifications then applying.

No all products which are exported to the EU do not require this form of certification. Only there are specific products which require this form of certification. Such products have to check if they come under the provisions of the new approach directives.

New approach directives are specific directives which are introduced by the EU commission in order to ensure that there is harmonisation with standards related to conformity.

Risk assessment is a process in which an assessment is carried out by the manufacturer if the product requires a form of certification. This assessment is required to be carried out by a manufacturer or importer.

The penalty for not securing this form of certification is penalties as levied by the commission.

Related Articles

Related Articles
05 Feb, 2019
CE Certification

6 Simple steps to get CE Marking Certification in India

Introduction to CE Marking Certification Getting a certified product or safe product is a right and desire of every customer around the world. CE is kind o...

Read More

Why Enterslice?

Top 100 Most Innovative Companies in Asia

Top 100 Most Innovative Companies in Asia - Red Herring

Forbes 30 Under 30 in American business

Forbes 30 Under 30 in American business and industry figures Lists.

Services delivered by 300+ Qualified CA and CS

Services delivered by 300+ Qualified CA and CS

Top 100 Most Innovative Companies in Asia - Red Herring

Top 100 Most Innovative Companies in Asia - Red Herring

Trusted Partner

Hey I'm Suman. Let's Talk!