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Contents

If you are new to the field of CE marking and are looking for some information to explain the basics, this page is a good place to start. Our website contains significant amounts of information about CE marking and some of it is necessarily detailed.

On our site you will find information on the CE marking process, background history, specific information about each CE marking directive (and some non-CE marking directives), the administrative requirements, testing requirements and much more. Use this page to learn the fundamentals of CE marking and when you are ready to learn more on the subject you are interested in, try looking at our detailed information pages.

What is CE Marking?

"CE marking" is a process that applies to a wide variety of products and one which manufacturers located in the EU or importers of goods into the EU must complete. Its purpose is to ensure that products within its scope are safe and suitable for sale in any of the EU Member States.

The CE mark is affixed to the product as the final stage of this process and is effectively a statement from the manufacturer (or importer) that the process has been successfully completed and that the product meets the essential requirements of the relevant CE marking Directives.

To learn more about CE marking, read our Introduction to CE Marking.

Which Products Need CE Marking?

In short, most of them! If the product falls within the scope of at least one of the CE marking directives and is not specifically excluded, it must be CE marked. Because the directives cover such a large range of products it is not practical (or possible!) to write a list of all the included and excluded products here.

However, if you follow the flowchart below you should get an understanding of the directives you need to be dealing with. Once you have identified the ones of interest, you can find out more about them on our detailed directives pages. The flowchart below illustrates the main safety directives. Click to view or download the flowchart as a PDF file with clickable links to more detailed information.

Flowchart for identification of applicable safety directives 

How to Get Your CE Marking?

To legitimately apply the CE Mark you must design a product to meet the relevant standards, creating a Technical File and producing a Declaration of Conformity.

However, underlying this is the obligation to that you have fulfilled the essential requirements of any relevant directives. These are in two parts: Protection requirements and Administrative requirements.

The protection requirements relate to the design of the product and can be satisfied by meeting the requirements of the relevant harmonised standards. The administrative requirements relate to how the product is CE marked. This generally involves the manufacturer producing a Declaration of Conformity and a technical file containing design/manufacturing information and also the application of the CE mark to the product. The flowchart below outlines the basic steps of the process.

CE Marking Process Flowchart

What Does CE Marking Involve?

  • European Directives and Regulations - Comprehensive detailed information about all CE marking directives and selected non-CE marking directives.
  • Introduction to CE Marking - Essential information on how the CE mark came about, what it is, and its implications for manufacturers.
  • Declaration of Conformity - Common to all the directives, the declaration is a signed document confirming that the item meets the requirements of the Directive.
  • Declaration of Incorporation - Specific to the Machinery Directive, this declaration enables incomplete machinery or components to be sold on the open market even though they do  not  Have a CE marking                                         
  • Technical File - Contains the information required to show the item properly complies with the requirements of the directive(s).
  • Standards for Product Safety - Provides a background explanation of the way in which standards are developed and used under the New Approach Directives.
  • Notified Body - An explanation about organisations which are authorised to make independent judgements as to whether a product meets directive requirements.
  • European Economic Area - Reference explanations of the member states of the European Union.
  • Authorised Representatives - Where the manufacturer is not based in the EU, legal responsibility for compliance with the directives lies with the person responsible for selling the goods within the EU.

What Are CE Marking Directives?

The CE marking directives are documents published by the European Commission that lay out the protection requirements (design safety) and the administrative requirements for products intended to be manufactured or imported into the EU. There are many Directives, covering a large range of products, but they all essentially contain these two distinct sets of requirements.

However, the directives do not state how the requirements are to be specifically and quantifiably achieved. This is the role of the standards. Various multinational committees meet to produce and update standards which contain requirements for the safe design of products.

 Standards are created by an international process which is ultimately driven by the European Commission.  The Commission identifies an area where they think that additional standardisation is required – either because what is there already is not working properly or because there are few standards because the industry is in its infancy - and funds the creation of new standards through European standardisation bodies, CENELEC (for electrical products) and CEN (for everything else). CEN and  CENELEC standards committee are made up of delegates from the Member States, and a well-balanced committee will have representatives of large and small manufacturers, regulators, testing and certifying bodies.

Once a standard has gone through all the various steps and a final version is published, the national standards bodies are under an obligation to publish it and to withdraw conflicting national standards. This is the driver behind the process of harmonisation (which makes it possible for a manufacturer to have a single design which is acceptable across the entire EEA).

The process of producing a standard which specifies requirements aligned to the essential requirements of a Directive is also known as harmonisation. In this situation a product which fully complies with the harmonised standards for a given Directive can be presumed to comply with the essential requirements of the Directive.

For a full list of the CE marking (and some non-CE marking) Directives, see our detailed directives pages.
For more information about standards, see our detailed standards page.

How Has Brexit Affected CE Marking?

This is what we know so far:

  • For most product sectors the government have now abandoned plans for the UKCA mark to become the exclusive mandatory alternative to the CE mark for goods sold within Great Britain.
  • Instead, for most products, if they have a CE mark this will be considered to be equivalent to a UKCA mark.

The main exceptions to this are for construction products and for medical devices

  • The CE mark will continue to be required for goods sold in Northern Ireland.
  • Products will be able to display both the UKCA mark and the CE logo unless and until the rules for those products diverge between the UK and EU.
  • It's not expected that significant divergence will happen in the near future except in the fields of construction products and medical devices.
  • Manufacturers of products which require third party (i.e. Notified Body) involvement as part of their CE marking process will have to use a UK Approved Body if they want to apply the UKCA mark.
  • Manufacturers based within Great Britain will need to identify a representative based within the EU whose name and address can go on the product as a contact point for the Market Surveillance Authorities.
  • Manufacturers based outside the UK and selling in the UK will need a UK based representative.

Learn more about the implications of Brexit on CE Marking here.

CE vs UKCA Marking Regulations

EU legislation

Ref. Number

UK legislation

Statutory Instrument

Toy Safety Directive 

2009/48/EC

Toys (Safety) Regulations 2011 

S.I. 2011:1881

Recreational Craft and Personal watercraft Directive 

2013/53/EU

Recreational Craft Regulations 2017 

S.I. 2017:737

Simple Pressure Vessels Directive 

2014/29/EU

Simple Pressure Vessels (Safety) Regulations 2016 

S.I. 2016:1092

Electromagnetic Compatibility Directive 

2014/30/EU

Electromagnetic Compatibility Regulations 2016

S.I. 2016:1091

Low Voltage Directive 

2014/35

Electrical Equipment (Safety) Regulations 2016

S.I. 2016:1101

Non-automatic Weighing Instruments Directive 

2014/31/EU

Non-automatic Weighing Instruments Regulations 2016

S.I. 2016:1152

Measuring Instruments Directive 

2014/32/EU

Measuring Instruments Regulations 2016

S.I. 2016:1153

Lifts Directive 

2014/33/EU

Lifts Regulations 2016

S.I. 2016:1093 

ATEX Directive 

2014/34/EU

Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres Regulations 2016

S.I. 2016:1107

Radio Equipment Directive 

2014/53/EU

Radio Equipment Regulations 2017

S.I. 2017:1206

Pressure Equipment Directive 

2014/68/EU

Pressure Equipment (Safety) Regulations 2016

S.I. 2016:1105

Personal Protective Equipment Regulation 

(EU) 2016/425

Personal Protective Equipment (Enforcement) Regulations 2018

S.I. 2018:390

Gas Appliances Regulation 

(EU) 2016/426

Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018

S.I. 2018:389

Machinery Directive 

2006/42/EC

Supply of Machinery (Safety) Regulations 2008

S.I. 2008:1597

Outdoor Equipment Noise Directive 

2000/14/EC

Noise Emission in the Environment by Equipment for Use Outdoors Regulations 2001

S.I. 2001:1701

Ecodesign Directive 

2009/125/EC

The Ecodesign for Energy-Related Products Regulations 2010

S.I. 2010:2617

Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive 

2011/65/EC

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012

S.I. 2012:3032

Explosives for Civil Uses Directive

2014/28/EU

The Explosives Regulations 2014

S.I. 2014:1638

Pyrotechnic Articles Directive

2013/29/EU

Pyrotechnic Articles (Safety) Regulations 2015

S.I. 2015:1553

 

Need Help With CE Marking?

Conformance is an independent consultancy that specialises in assisting manufacturers and importers to correctly navigate the CE marking procedure and ensure they have met all of their obligations.

There is significant effort and time required to understand the CE marking procedure and to correctly fulfil the requirements contained in it. As an alternative to doing this "in-house", Conformance can offer a very competitive and comprehensive service.

For a full description of the services we offer, please see our services page.

Introduction to CE and UKCA Marking your Products

This course will guide you through the complete CE marking process, from design considerations and finding the right standards to completing all the necessary documentation.

Read more: Introduction to CE and UKCA Marking your Products

CE and UKCA Marking Machinery & Industrial Equipment

This course will give you an understanding of how to carry out machinery assessments, including finding and applying the relevant standards, and the documentation that must be provided.

Read more: CE and UKCA Marking Machinery & Industrial Equipment

Machinery Risk Assessment Training

This course explains the role of standards in the risk assessment process, to enable designers and project managers to carry out the risk assessment in the most efficient way.

Read more: Machinery Risk Assessment Training

Pressure Equipment Directive Training Course

This course provides an overview of the Pressure Equipment Directive, where you will learn who should take responsibility, how to find and apply standards, what documentation you need to produce.

Read more: Pressure Equipment Directive Training Course

ATEX Compliance & Risk Assessment Course

This course will take you through the CE and Ex marking process in detail. You will gain an understanding of the requirements, including the various options for ensuring equipment is safe.

Read more: ATEX Compliance & Risk Assessment Course

CE & UKCA Marking Electrical Equipment Training Course

This course will explain who is responsible for CE marking, and what should be done to carry out the process correctly, as well as looking into the directives and standards involved.

Read more: CE & UKCA Marking Electrical Equipment Training Course

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