CE Marking and other forms of regulatory compliance can be confusing, here are a few of the most common questions we are asked by our customers.
What is CE Marking?
CE Marking is a certification mark that shows compliance with the relevant health, safety and environmental regulations for products sold or used in the European Union.
Do I need CE Marking?
CE Marking is mandatory for any product that is marketed or placed into use in the EU, regardless of its origin, and that falls within the scope of certain product ‘Directives’ published by the European Union.
What is an EU Directive?
A Directive is an EU legislative act that sets out a goal that all EU member states must achieve. (It is up to the individual countries to devise their own laws on how to reach these goals). The EU has issued Directives covering hundreds of subjects, most of which do not require the use of the CE Mark. Those Directives that do require the use of the CE Mark are commonly described as New Legislative Framework or NLF Directives.
What is a Notified Body?
An organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. The term ‘Notified’ comes from the fact that EU Member States must notify the European Commission when they accredit an organisation to undertake conformity assessments.
Can I do CE Marking myself?
It depends on the applicable Directive and the type of Product.
Some EU Directives include mandatory requirements for assessment by a Notified Body as part of the certification process, but only for certain types or categories of product. Other Directives allow the manufacturer or responsible person to ‘self-declare’ conformity, with no need for external assessment.
We recommend that you seek qualified advice before embarking on the CE Marking process, to ensure that you fully understand the requirements specific to your product. You may be able to complete the entire process yourself, but it's always wise to check beforehand to avoid delays later.
Where do I buy a CE Mark?
A CE Mark cannot be bought, it is simply a logo which a manufacturer or responsible person should attach to a product to show that it conforms to all the applicable European Directives.
Fees will be incurred if assessment by a Notified Body is required as part of the CE certification process. However, Notified Bodies do not ‘award’ the CE Mark; they simply confirm whether conformity with a specific Directive has been demonstrated.
How long does a CE Mark last?
In theory, a CE Mark can continue to be affixed to a product indefinitely, as long as the product’s design does not change, the applicable Directives are not subject to any revisions and any relevant product standards are not updated.
However, in reality it is necessary for manufacturers to review the continuing validity of CE Marks on a regular basis to confirm that any changes to either a product or the wider regulatory environment have been addressed.
Do I need a Notified Body?
This will depend on the Directive(s) that is/are applicable to a Product.
Some Directives, such as the Low Voltage Directive 2014/35/EU, never require the use of a Notified Body, whilst others, such as the Machinery Directive, only mandate the involvement of an Notified Body in limited and very specific circumstances. However, when applying some Directives, such as the ATEX Directive 2014/34/EU, the involvement of a Notified Body will be required in the majority of circumstances.
What is a Declaration of Conformity?
Whilst a CE Mark affixed to a Product is a visual indication of conformity to the applicable EU Directives, it is not sufficient evidence of compliance by itself. Manufacturers are also required to issue an EU Declaration of Conformity (DoC), that must either accompany a product when it is shipped or be available on request.
A DoC is a legally binding declaration by the manufacturer of a product, or the party legally responsible for its certification, that it complies with all the applicable EU Directives. In addition to identifying the party or parties legally responsible for compliance, the DoC also provides information regarding the specific Directives and standards that the Product complies with.
A CE Mark cannot be considered valid without a correctly prepared EU DoC.
What is the Difference Between European Directives and Standards?
European Directives, such as the EMC Directive 2014/30/EU, specify the legal requirements products must meet and the acceptable methodologies for demonstrating that they do. Directives are legally binding and enforceable.
European Standards, also known as European Norm or EN Standards, can be used to demonstrate that a product meets the requirements of a specific Directive. The use of Standards is voluntary and it up to manufacturers to decide which Standards to apply to a product. Standards that can be used to demonstrate conformity to a Directive are referred to as ‘harmonised’. The European Commission publishes a list of all Harmonised Standards on their website here.
Does a Company Have to CE Mark Equipment Made for its Own Use?
Yes, equipment manufactured by a Company for its own use, such as specialist production tools, must comply with any applicable EU Directives and if necessary, carry a CE Mark. Products do not need to be sold commercially for a CE Mark to be required.
When Do I Have to Complete the CE Marking Process?
A product or a piece of equipment should carry a valid CE Mark when it is either ‘placed on the market’ or ‘brought into service’ in the EU.
Placed on the Market is defined as being when a product is made available for purchase in the EU and would apply to most commercially available products.
Brought into Service is when a product is used for the first time within the EU and would commonly apply to equipment made for own use or constructed on-site.
What is a Technical File?
Many EU Directives require that manufacturers prepare sets of ‘Technical Documentation’ for their products. Such sets of technical documentation are commonly known as Technical Files and provide detailed evidence of conformity with the requirements of applicable EU Directive.
If the conformity of a product is ever queried, the authorities in the EU may request a copy of the Technical File from the manufacturer. If some form of Notified Body assessment is required a copy of the Technical File will often have to be submitted for review as part of the process.
Do I Need to Register my CE Marked Products?
In most cases no, there is no facility to register a CE Mark or the product that carries it. Some Directives and Regulations, such as those covering Medical Devices, do require products that fall within their scope to be registered with the authorities, but these are the exceptions rather than the rule.
Who is Legally Responsible for CE Marking A Product?
If the manufacturer of a product is located within the European Union, they will automatically become legally responsible for ensuring their products carry a valid CE Mark.
If the manufacturer is located outside of the EU and has no legal presence in any of the member states, other parties may become legally responsible for CE Marking by default.
Any parties involved in the importation or sale of a product into the EU could become responsible. Collectively under EU regulations they are known as Economic Operators, and they include:
- Authorised Representatives
- Fulfilment Service Providers
If you intending to import a product into the EU from a manufacturer located overseas, either for onward sale or for your own use, it is recommended that you confirm whether you will be responsible for the CE compliance of the items you are importing.
What is an Authorised Representative?
An Authorised Representative, also known as a European Authorised Representative or EAT, serves as a legal entity designated by non-European Union manufacturers, to represent them in the EU and ensure their compliance with the European Directives.
Authorised Representatives must be located within the EU and be formally appointed by a manufacturer, with a contract between both parties setting out their responsibilities. It is not possible to become an Authorised Representative by default or without a mutual agreement.