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CE-Marking

Ferry Vermeulen Law & Legislation

What is CE Marking (CE mark)?

CE marking is a marking on specific products indicating that the manufacturer declares compliance of that product with the relevant European product safety legislation.

What Does CE Marking Mean?

When a product is CE marked, it means that the manufacturer has verified compliance with the essential health and safety requirements as indicated in the applicable European Directives and Regulations.

By marking the product, the manufacturer takes full responsibility and liability over the product.

The CE Marking is found on many products that are traded within the European Economic Area (The EEA consists of all 28 EU countries and Iceland, Liechtenstein and Norway).

The letters CE stand for Conformité Européenne, meaning European Conformity.

CE mark

Is CE Marking Mandatory?

CE marking is mandatory for products that fall under one of the 25 CE Directives or Regulations. When a product is not covered by one of these Directives or Regulations, affixing the CE mark is forbidden. Often, more than one Directive or Regulation can be applicable to a product. 

To determine if a Directive or Regulation applies to a product, consult the Scope and the Definitions of the directive. Also, check the exceptions that are not covered by the directive to find out if your product is excluded. 

What Products Need CE Marking? 

Products that fall under the scope of the following Directives and Regulations require CE Marking:

  • Directive 2006/42/EC on Machinery
  • Directive 2000/14/EC on Noise Equipment for use outdoors
  • Directive 2000/9/EC on Cableway Installations
  • Directive 2009/125/EC on Energy-Related Products
  • Directive 2009/142/EC on Gas Appliances
  • Directive 2009/48/EC on Toy Safety
  • Directive 2011/65/EU on the restrictions of the use of certain hazardous substances in electrical equipment
  • Directive 2013/29/EU on Pyrotechnic Articles
  • Directive 92/42/EEC on Hot Water Boilers
  • Directive 2014/28/EU on Explosives for civil uses
  • Directive 2014/29/EU on Pressure Vessels
  • Directive 2014/30/EU relating to Electromagnetic Compatibility
  • Directive 2014/31/EU on Weighing Instruments
  • Directive 2014/32/EU on Measuring Instruments
  • Directive 2014/33/EU on Lifts
  • Directive 2014/34/EU relating to equipment and protective systems for use in potentially explosive atmospheres.
  • Directive 2014/35/EU  relating to the making available on the market of electrical equipment designed for use within certain voltage limits 
  • Directive 2014/53/EU relating to Radio Equipment
  • Directive 90/385/EEC on Active Implantable Medical Devices
  • Directive 2013/53/EU on Recreational Craft
  • Directive 2014/68/EU on Pressure Equipment
  • Directive 98/79/EC on in vitro diagnostic medical devices
  • Regulation (EU) No 305/2011 on Construction Products
  • Regulation (EU) 2017/745 on Medical Devices
  • Regulation (EU) 2016/425 on Personal Protective Equipment

The CE marking is not required for products such as pharmaceuticals, chemicals, cosmetics and food.

What are the benefits of CE Marking?

Products that comply with the CE Marking requirements, benefit from the following:

Free movement of goods

When your product complies with the CE Marking requirements, the product can move freely between the member states. The member states together, operate as an internal (or single) market. Withing the single market, compliant products can be traded without any restrictions. As such, the CE Marking can be seen as some kind of passport for the European marketplace. 

High level of health, safety and environmental protection 

Products that comply, have a high level of health, safety and environmental protection, as they meet the requirements of the European Directives. When the manufacturer applied harmonised standards to comply with the requirements of the directives, he or she has taken account of the current state-of-the-art with respect to health, safety and environmental protection. Consumers and users of CE marked products enjoy the same level of protection. 

Which countries accept the CE Mark? 

CE marking basically is a set of rules for certain products that are sold withing the European Economic Area (EEA). The EEA consists of all 28 EU countries and Iceland, Liechtenstein and Norway).

The EU countries are:

  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (until March 29th 2019)

The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EU’s single market.

All these countries operate as a single market which allows free movement of goods, capital, services and people between its member states.

Switzerland is neither an EU nor EEA member but is part of the single market. This means that CE products can be sold in Switzerland. 

Also Turkey is neither member of the EU, nor part of the EEA. However, as Turkey has fully implemented most of the European CE marking directives, this de facto means that a CE marked products can be sold freely in Turkey. 

countries that accept the CE mark

Countries that accept the CE mark (image from csiassoc.com)

 

What are the responsibilities of manufacturers, importers and distributors

It is the responsibility of the person that places a product on the European market that the product complies with the requirements of the CE marking directives and/or regulations.

So who is this person exactly?

This can be the manufacturer, the importer or the distributor. All three might have different responsibilities.

A manufacturer is any natural or legal person who places a product on the EU market under his own name or trademark, regardless of whether someone manufactures a product or has a product designed and/or manufactured.

All manufacturers are responsible for completing the CE marking process and thus making sure that the product complies with the relevant European legislation.

Manufacturers from outside the EU may appoint an authorised representative. This can be an importer or distributor.

And what are the importer’s responsibilities?

Importers that import a product from outside the EU are responsible for making sure that the product complies before placing it on the market.

They need to make sure that the manufacturer from outside the EU has fulfilled all obligations, such as completing the conformity assessment procedure, compiling the technical file and drafting the declaration of conformity.

As importers are considered to be producers under the Product Liability Directive, they are fully liable for the products that they place on the European market.

Let’s look at an example.

We hear quite often that an importer thinks that a product complies because the non-European manufacturer has sent him a declaration of conformity.

It is the responsibility of the importer to verify that the product complies by checking the completeness, compliance and authenticity of the FULL technical file.

When an importer thinks that the product which they have placed on the market does not conform to the European legislation, they must directly bring that product into conformity, withdraw it or recall it.

So what about distributors?

Distributors are any natural or legal persons in the supply chain, such as retailers and wholesalers, who make products available on the market.

A distributor buys a product from a manufacturer, importer or other distributors. They have to be aware of the CE-marking regulations and know which products should be CE marked and what the requirements on the language, labelling, packaging and user instructions are.

It is their responsibility not to supply products that ‘they know or should have assumed, on the basis of information in their possession and as a professional ‘are not in compliance with the legislation.

Also note that when a distributor or an importer modifies a product or markets it under their own name, they are legally seen as the manufacturer and take over all responsibilities.

How do I get CE marking?

Do you want to know how to get CE marking? There are several ways to obtain CE marking...

Of course you can outsource the entire CE process, but there is something that many people do not know.

And that is that CE marking in principle is a self-certification process. Only for a few products it is required to have the product tested and certified by a Notified Body.

This means that for most products you don’t need a Notified Body. In these cases you can still outsource parts of the CE marking process and work with a CE expert (not to mix up with a NoBo), have only the tests done by a testing lab (also not to mix up with a NoBo), or do everything yourself, when you have the right equipment of course.

Let’s put this clearly in an overview

Notified Body Only needed when required by certain Directives and for certain product groups
Testing Lab Can help you conducting tests such as flammability test (for toys),, EMC test or Low Voltage test
CE Consultants an guide you through the entire CE process, contact suppliers, determine if certification by a third party (NoBo) is required, conduct a risk analysis (if required) etc.
Technical documentation agency Supports you with creating the user and safety instructions

A common heard mistake

Be aware of this often heard mistake…

Sometimes I hear that people want to get a CE certificate or say that they don’t need to do CE marking, because they already have a CE certificate from their manufacturer.

This is wrong!

The CE certificate that a manufacturer often claims to have, is ‘just’ a test report, such as an EMC report or LVD report. That is just one of the required technical documents as part of the conformity assessment (step 4) and the which should be included in the technical file (step 5).

Other people nickname the Declaration of Conformity as a CE certificate. This is not the correct name. Also, be aware that the Declaration of Conformity should always be signed by the person that places the product on the European market.

What's next?

How Does the CE Marking Process Look Like?

 

 

Resources: