CE Certification

CE Certification -The Ultimate Guide

Before you import from China to Eurozone or any global market, your products should have CE certification.

So, if you want to know what CE is, benefits, why you need it, validity period or any other information concerning this certification, you will find it right here.

Keep reading to learn.

What is CE Certification?

CE Certification

CE Certification

CE certification is a self-accreditation scheme to demonstrate the products comply with the respective European directives.

These directives revolve around health, safety, and environmental protection legislation.

The letters are an acronym for Conformité Européene, which merely means European Conformity.

Essentially, CE certification is proof that the product meets minimum legal requirements of the relevant directive.

Conformity to such directives allows the product to be placed legally on the market of a European member state.

Commodities meeting the minimum CE certification requirements are marked with a logo showing their compliance.

Consequently, such products enjoy free movement across the EU trading member states.

In that regard, the European Commission often refers to CE certification as the “European Passport” for goods.

Importance of CE Certification

CE certification is fundamental to both manufacturers and end-users in the European market.

Some of the reasons why this marking is important are as follows;

1) Renders Assurance Regarding Safety and Protection

Several products, especially electronics, tend to have unseen hazards likely to become prominent as days go by.

It means the end-users are more likely to get affected by exposure to such products when frequently used.

However, CE certification assures unparalleled safety and protection to end-users.

The product remains authentic and hazardless as long as the consumer uses it under stipulated operating conditions.

2) Global Recognition

CE is a globally recognized certification standard for product safety and protection.

Most commodities with CE marking can be sold in different parts of the world without any legal barrier.

Additionally, the CE marking allows a manufacturer to declare the commodity meets European standards of safety legislation.

3) Standardized Marking

Under EU directives, manufacturer hardly needs to serve different regulations when producing their products.

In essence, it helps the manufacturers and traders to overcome unnecessary inter-state conflicts over regulations.

Technically, manufacturers do not need to adopt distinctive bylaws to produce commodities for the respective markets.

4) Seamless Trading of Commodities

The essence of CE certification is to boost trading of different commodities between EU countries.

CE marking emerges as a global accreditation of safety and protection.

It is necessary since it enables the end-users to overcome skepticism regarding product vulnerability.

Ordinarily, this certification helps manufacturers in gaining credibility for their product line over time and to confront competition easily.

Moreover, CE certification gives your business relatively easy access into the European market to sell your commodities without adaptation or rechecking.

How to Check if a Product is CE Certified

Ideally, the easiest way to determine whether a product is CE certified is by checking the symbol.

The CE certification symbol should be on specific products, packaging, or information it came with.

If you’re suspicious, the manufacturer could be misusing the CE certification symbol;you can request certificate conformity or performance declaration.

This provides test results and other details about how the commodity meets the relevant requirements.

Types of Products that need CE Certification

Ideally, not all products sold in the European Union need to bear the CE certification symbol.

This marking is only mandatory for commodities falling under the scope of one or more European Commission product directives.

Often, this is referred to as New Approach Directives.

Here are some of the product groups, which CE marking applies;

  • Active implantable medical equipment
  • Devices burning gaseous fuels
  • Construction products and appliances
  • Hot water boilers
  • Lifts
  • Machinery
  • Measuring instruments
  • Recreational craft
  • Toys
  • Eco-design of energy-related commodities
  • Radio equipment
  • Household refrigerators and freezers
  • Diagnostic medical devices
  • Basic pressure vessels
  • Pressure equipment
  • Explosive for civil uses
  • Cableway installations to carry persons
  • Measuring devices
  • Non-automatic weighing devices
  • Electromagnetic compatibility
  • Telecommunications terminal equipment
  • Personal protective equipment
  • Pyrotechnics

Who issues CE Certification for Importing from China

CE certification is issued by the respective Notified Body in China when importing from the same country.

Essentially, a notified body refers to a conformity assessment agency, which has been notified by a member state of European Commission.

The role of the notified body, in this case, is to conduct conformity assessment activities for a given directive.

This body is evaluated by the competent state authority in the particular directive for which it is notified.

As a buyer, it is your responsibility to obtain the CE certification when importing from China.

Technically, you have to ensure you obtain a Technical File and Declaration of Conformity documents to validate the certification.

Countries that Require CE Certification

There are about 31 countries within the European Economic Area that require CE certification, which include the following;

  • Three-member states of the European Free Trade Association, i.e., Norway, Iceland, and Liechtenstein.
  • All the 28 European Union member states i.e.
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom

Difference between CE and EC Certification

Certificate of conformity

Certificate of conformity

Ideally, there is a thin line between CE and EC certification.

CE is a conformity mark symbolizing the compliance of the commodity with all the necessary applicable European Community directives.

The specific directives and technical standards in CE often vary depending on the product type.

On the other hand, EC certification is a Declaration of Conformity in form of a written statement drawn up by the manufacturer.

It demonstrates the fulfillment of EU requirements in relation to a product bearing CE marking.

This declaration must be in respect of all community acts applicable.

That is, to the product containing all information necessary for identification of Community harmonization legislation relating to the declaration.

How to get CE Certification

When seeking CE certification, it is vital first to establish the particular directives that apply to the particular commodity.

It is relatively impossible to draw up hard-and-first-rules and also fundamental to seek independent advice if in doubt.

Importantly, you need to understand that not all CE directives relate to products.

For instance, General Product Safety Directive requires CE marking, nor a particular Directive applies to all products described by the title.

Again, Machinery Directive hardly applies to every conceivable product, which might necessarily be termed as a machine.

Therefore, there is a need to study the specific regulations implementing the Directives.

Is CE Certification Mandatory when Importing from China

Not really.

CE certification is only mandatory if you are importing goods from China to the European Union market.

For other countries such as Australia, the USA, or any other market, this particular certification is not mandatory.

You may consider it since it places high standards on safety, environment, and health protection on the commodities.

And this gives it an upper hand when it gets to other non-European markets.

However, it is not mandatory in any other market apart from the European Union member states.

CE certification on charger

CE certification on charger

CE Certification Process

CE certification process is relatively meticulous and involves a number of fundamental elements.

There are  different steps involved in getting CE certification, and they include the following;

1. Finding CE Directives Applicable to your Product

This first step entails determining if your product is covered under one or more of the available CE directives.

A directive essentially is a legislative act of the European Union.

It requires member states to adapt their national goals to harmonize the EU rules in the area.

2. Understand the Essential Requirements of your Product

Each directive details the specifics the EU legally needs for the commodity to be compliant, also known as essential requirements in the directive.

These requirements are somewhat general and hardly details how to design a product to meet the essential requirements.

3. Figure-out of you need Third Party Assessment

Some directives demand that products must be tested and accredited by third party organization.

In essence, this helps in ensuring their conformity with applicable essential requirements.

There are directives, which indicate the manufacturer must use a Notified Body for particular products.

4. Assessing Product Conformity

This step involves testing and documenting how your product performs.

Every directive outlines the specific conformity assessment procedures a manufacturer can undertake.

Conformity assessment modules are classified into eight categories.

5. Creating and Maintaining Technical Documentation

All CE certification directives impose an obligation to the manufacturer to design and make available technical documentation.

This documentation should contain information demonstrating the product conforming to the respective requirements of the directive.

6. Declaration of Conformity

This is about certification of products compliance with CE marking directives.

Essentially, it is an acknowledgment by the manufacturer that they are responsible for compliance of its commodities with applicable directives.

7. Counter-check with other National Requirements

The essence here is to ensure there are no other purely national requirements existing in the particular country where the commodity is to be sold.

8. Arrange for Product Testing

At this point, all you need is to make sure the products are ready to undertake the respective testing process.

9. Affixing CE Mark

CE symbol must be affixed to all new products regardless of the country of manufacturing, used, and second hands or modified.

However, directions may exclude the application of CE symbol on particular products, but these often vary from one product to another.

Validity Period of CE Certification

It is contingent on some specific factors surrounding the product directive.

For instance, under the current systems, CE certification issued by Notified Bodies tend to be valid for three years.

The validity period for some high-risk devices may be one year only.

Nonetheless, the status of CE certification is largely dependent on maintaining the quality of your system.

On the other hand, the EC Declaration of Conformity is valid for an indefinite period.

It stays valid for the commodity for as long as there are no major changes made on the product, such as;

  • Change of original operation
  • Change of type
  • Change of original intended use
  • Use of new suppliers
  • Use of other components

Under such circumstances, the product is regarded as a new product, thus the need for a re-evaluation certification process.

A proposal for a new EC Declaration of Conformity based on new guidelines needs to be developed.

The EC Declaration of Conformity must thus be kept for at least ten years after the last date of product manufacturer.

An exception to this is only when the directive expressly indicates another term.

Why it is Important to Use a Notified Body for CE Certification

Technically, the major role of a Notified Body is to review the Declaration of Conformity, lab-test report, and technical file.

This body assesses whether your product conforms to the vital requirements listed in the relevant directive.

Some of these requirements include inspection, quality assurance, design examination, or a combination of these.

Subsequently, it issues an EC certificate once they approve the documents.

Furthermore, using a Notified body allows you to benefit from expert knowledge, experience, independence, and resources.

Is CE Certification Mandatory in the USA

No.

The US system does not use CE marking or any other general conformity marking.

Same federal agencies conduct both the design of safety requirements and inspection on compliance of products in the US.

Moreover, product requirements in the US are based on national laws as enacted by congress.

Therefore, CE is never considered as a compulsory certification marking for products in the USA.

Can all Chinese Manufacturers Produce CE Compliant Products

No.

Actually, it is rather the opposite because only a few about 5-10% of Chinese manufacturers can produce CE compliant goods.

Even so, it doesn’t imply that an entire factory can be CE compliant.

CE marking is based on a particular product.

Even manufacturers that demonstrate previous compliance such as past test reports do not always manufacture CE marked products by default.

Looking at previous CE compliance when selecting an ideal manufacturer is a way to determine a supplier’s ability to produce compliant products.

A manufacturer can hardly be CE compliant by default regardless.

Thus, before making an order, you need to ensure the supplier is aware of your compliance requirements.

It allows you to prevent severe compliance issues likely to arise from simply referring and considering a particular Chinese manufacturer as CE compliant.

Always confirm the exact CE directives your products need to comply with and communicate them to the manufacturer accordingly.

To verify compliance, you must implement the necessary testing and certification procedure.

You cannot rely on existing CE certification, but you must submit reference prototypes to a testing company before mass production.

Documentation of CE Certification

CE certification revolves around a number of documentation to facilitate the marking process of the product.

The documentation involves the following;

CE Certification

CE certification

a) Declaration of Conformity

Abbreviated as DoC, this document is issued either by the importer or manufacturer.

It is the primary document for demonstrating compliance to the respective government bodies, retailers, and end-users.

DoC contains the following details;

  • Product identification
  • Product features
  • Name and address of manufacturer/importer
  • List of EN standards or directives
  • Location
  • Responsible individual

b) Technical File

This is a document regarding the various technical aspects of a commodity combined with testing and quality protocols and documents.

As an importer, you are also required to set up a technical file in addition to the DoC document.

Technical file contains the following information at a minimum;

  • Items description
  • Concept prototype (drawings, designs, wiring, component scheme, part list, sub-assemblies, etc.)
  • List of standards applied partially or fully
  • Testing and quality control procedures
  • Test reports and quality control details
  • Marking and labeling copies
  • Risk assessment

Nevertheless, the specific details a technical file shall include are outlined in the applicable CE directive.

Technical file cannot be made public or shared with retailers and end-users, unlike DoC.

You must present it to the only upon request by the EU or local authorities.

As an importer, you thus need to obtain this document from your respective Chinese manufacturer.

Technical file contains detailed product information like product prototype; thus manufacturers are never willing to issue it before you place an order.

In the same regard, the best way to get a technical file is by creating it entirely on your own.

And this is never an issue, especially when creating custom-made products.

However, technical files for private label products need a particular extent of reverse engineering.

c) User Manual

A user manual is a mandatory document, which you must create and should capture the following details;

  • Product installation instructions
  • Safety details
  • Overview of relevant parts and respective names of the product
  • Instructions on how to use the product
  • Recharge/Refill instructions of the product
  • Product disposal in environmental-friendly instructions

d) Test Report

It is part of a technical file, but you can never rely entirely on the manufacturer’s test reports.

Customs officials and consumer market surveillance authorities usually request test reports to verify products’ compliance.

Technically, these authorities have a legal right to seize and order a recall for any commodity they deem unsafe.

Importantly, you need to be cautious of unscrupulous suppliers issuing fake CE documents in China and the EU.

Some documents such as CE certificate, CE compliance Assessment, and Attestation of conformity can be misleading.

They are issued based on technical and file test reports.

However, most of these documents are often issued without undertaking any of such reviews.

Even if such a review takes place, a third-party CE certificate can hardly be a replacement for DoC, technical file, and lab test report.

Manufacturer’s Responsibilities Regarding CE Certification

Ideally, a manufacturer refers to the party responsible for designing and producing the product.

The objective of the manufacturer is always to place the product either under their brand or buyers’ name.

In CE marking, it doesn’t matter whether the party involved designs, manufacturers, processes, labels, and packs the product.

It also never matters in CE certification whether the manufacturer subcontracts out full or part of their respective responsibilities.

Principally, the manufacturer’s responsibility herein is ensuring products are designed and created in compliance with relevant legislation.

Moreover, they should draw up the necessary technical documentation and ensure correct assessment procedures are undertaken.

Immediately the manufacturer demonstrates compliance, and they need to write up a performance declaration.

Alternatively, they can write up a certificate of conformity and affix a CE mark to the commodity.

Other responsibilities of the manufacturer regarding CE certification include the following;

  • Keeping records such as technical documentation and declarations of performance.
  • Making sure ideal procedures are in place to help in maintaining conformity consistency in series productions.
  • Ensuring all products bear a unique type, batch, or serial number vital for identification purposes. It may also be incorporated into the packaging or document accompanying the product.
  • Indicating the name, registered business name, and address. It should also be on the product, packaging, or document accompanying the commodity.
  • Ensuring the product contains instructions and safety details in a language the end-users can easily understand.
  • Taking appropriate measures in case the product is deemed non-compliance to respective regulations.

This may include correcting the fault, withdrawing, or recalling the product from the market.

  • Providing relevant authorities with information and documentation as necessary to exhibit conformity of the product.

Importer’s Responsibilities Regarding CE Certification

Technically, when you are importing products manufactured overseas, your main responsibility is ensuring compliance with applicable directives.

In these circumstances, the importer is considered the manufacturer.

There are numerous instances where importers have failed to produce requested documentation to demonstrate CE marking compliance.

Subsequently, customs authorities have blocked entry for such shipments into the respective country of destination.

Seller’s Responsibilities Regarding CE Certification

The legal responsibility of a seller in CE certification is to ensure all products they sell have correct CE marking.

In most European countries, the penalty for supplying non-compliant products is imprisonment or a hefty fine.

Regulations allow authorities to enter a premise, test the products and impound both the documentation and commodities.

The authorities also have the legal rights to force manufacturers to recall products or replace the faulty ones.

Relationship between CE Certification and Product Liability

European Product Liability Directive stipulates that consumers don’t have to prove a product has caused damage.

It is the manufacturer’s responsibility to demonstrate the product is not faulty since they are liable for damage caused by a defect.

CE certification often includes minimum safety requirements.

Therefore, manufacturers can use certificates of conformity test reports and other relevant documentation to prove compliance.

Even so, CE certification doesn’t indicate a product is approved to be safe by the EU or any other relevant authority.

How CE Marking is Enforced

Several agencies enforce CE certification with the aim of preventing misuse of the mark.

Ideally, enforcement of this certification varies depending on different directives.

Some are enforced by local Trading Standards Departments (TSD) and others by HSE among others.

It is necessary since it guarantees product safety is maintained.

In each member state within the European Union has nominated public authorities known as Market Surveillance Authorities.

These authorities are tasked with making sure that CE certification is enforced in various businesses and imports from the Non-EU region.

What happens if a Product Fails CE Certification Test

CE certification

CE certification

In case a product fails to meet the CE certification, it cannot legally be sold in any European Union member state.

And should the manufacturer falsely CE marks a product, the maximum penalty is three months imprisonment.

A fine of 5,000 Euros is also imposed on the director of the offending company.

These penalties are also imposed on a manufacturer who fails to CE mark a commodity for which it is required.

In other words, a product that does not meet CE certifications is unacceptable in the European Union market.

At BanSar, we ensure all your products have CE certification before shipping from China.

For any questions or inquiry about CE certification or any other certification, BanSar team is here to help – contact us.

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