Overview

The letters ‘CE’ appear on many products that are traded on the single market in the European
Economic Area (EEA).

The CE marking is required for many products. It:

 shows that the manufacturer has checked that these products meet EU safety,
health, or environmental requirements
 is an indicator of a product’s compliance with EU legislation
 allows the free movement of products within the European market

By placing the CE marking on a product a manufacturer is declaring, on his sole responsibility,

conformity with all of the legal requirements to achieve CE marking. The manufacturer is thus
ensuring validity for that product to be sold throughout the EEA. This also applies to products made in
third countries which are sold in the EEA and Turkey.

Not all products must bear the CE marking. Only those product categories subject to specific
directives that provide for the CE marking are required to be CE marked.

CE marking does not mean that a product was made in the EEA, but states that the product is
assessed before being placed on the market. It means the product satisfies the legislative
requirements to be sold there. It means that the manufacturer has checked that the product complies
with all relevant essential requirements, for example health and safety requirements.

If you are a manufacturer it is your responsibility to:

 carry out the conformity assessment

 set up the technical file
 issue the EC Declaration of Conformity (DoC)
 place CE marking on a product

If you are a distributor you must check the presence of both the CE marking and the necessary
supporting documentation.

If you are importing a product that is from a third country you have to check that the manufacturer
outside the EU has undertaken the necessary steps. You must check that the documentation is
available.

Products that need CE marking

CE marking is mandatory, but only for those products which are covered by the scope of one or more
of the New Approach Directives.

You can view the EC New Approach Directives guidance from the Europa website.

Even if your product is manufactured outside the EEA, you must ensure the product
bears CE marking if your product comes under the scope of a directive requiring CE Marking. Not all
products sold in the EU need to bear CE marking.

CE marking applies to products, ranging from electrical equipment to toys and from civil explosives to
medical devices. The full list of these product categories is below:

 active implantable medical devices

 appliances burning gaseous fuels
 cableway installations designed to carry persons
 eco-design of energy related products
 electromagnetic compatibility
 equipment and protective systems intended for use in potentially explosive
atmospheres
 explosives for civil uses
 hot-water boilers
 household refrigerators and freezers
 in vitro diagnostic medical devices
 lifts
 low voltage
 machinery
 measuring instruments
 medical devices
 noise emission in the environment
 non-automatic weighing instruments
 personal protective equipment
 pressure equipment
 pyrotechnics
 radio and telecommunications terminal equipment
 recreational craft
 safety of toys
 simple pressure vessels

The CE marking is not required for items, for example:

 chemicals
 pharmaceuticals
 cosmetics and foodstuffs
If you have an enquiry about the Construction Products Regulations or if you would like information on
the new requirements for structural steel, which came into force on 1 July you can
email construction.products@communities.gov.uk.

How to place a CE marking on a product

Before you place a CE marking on a product, you need to establish which EU New Approach
Directives apply to your product. You must not attach a CE marking to a product outside the scope of
the directives.

The process you follow depends on the directives that apply to your product.

1. Identify the directive(s) and harmonised standards applicable to the product

There are more than 20 directives setting out the product categories requiring CE marking. The
essential requirements that products have to fulfil, for example safety, are created at EU level and are
set out in general terms in these directives. Harmonised European standards are issued with
reference to the applied directives and express the essential safety requirements in detailed technical
terms.

2. Check the product-specific requirements

It is up to you to ensure that your product complies with the essential requirements of the
relevant EU legislation. The use of harmonised standards remains voluntary. You may decide to
choose other ways to fulfil these essential requirements. If you don’t follow the safety requirements of
a standard as it is written you will need to show that your product is as safe, by presenting the
relevant documentation.

3. Identify whether an independent conformity assessment is required from a Notified Body

Each directive covering your product specifies whether an authorised third party (Notified Body) must
be involved in the conformity assessment procedure necessary for CE marking. This is not obligatory
for all products, so it is important to check whether the involvement of a Notified Body is required.
These bodies are authorised by national authorities and officially ‘notified’ to the European
Commission and listed on the NANDO (New Approach Notified and Designated
Organisations) database.

UK conformity assessment bodies can no longer carry out mandatory conformity assessment for
products being placed on the EU market.

4. Test the product and check its conformity

If you manufacture a product it is your responsibility to test the product and check its conformity to
the EU legislation (conformity assessment procedure). One part of the procedure is, as a general rule,
a risk assessment. By applying the relevant harmonised European standards, you will be able to fulfil
the essential legislative requirements of the directives.

5. Draw up and keep available the required technical documentation

If you manufacture a product you need to establish the technical documentation required by the
directive(s) for the assessment of the product’s conformity to the relevant requirements, and for the
risk assessment. You must be able to present the technical documentation and EC DoC to the
relevant national authorities, if requested.

6. Placing the CE marking on your product and EC Declaration of Conformity

The CE marking must be placed on the product by the manufacturer, or by his authorised
representative within the EEA or Turkey. It must be placed according to its legal format to the product
or its data plate. It must be visible, legible and impossible to remove. If a Notified Body was involved
in the production control phase, its identification number must also be displayed. It is the
manufacturer’s responsibility to draw up and sign an ‘EC DoC’ proving that the product meets the
requirements. That’s it, your CE-marked product is ready for the market.

Using the CE marking

Once you have satisfied the conformity assessment requirements for CE marking you must attach
the CE marking to your product or its packaging. There are specific rules for using the CE marking for
your product, as well as rules for the reproduction of the CE marking logo.

In general you should attach the CE marking to the product itself but it may also be placed on the
packaging, in manuals and on other supporting literature. Rules covering the use of the CE markings
vary depending on the specific EU directive that applies to the product and it is advisable to study the
applicable guidance. The following general rules all apply:

 CE markings must only be placed by you - as the manufacturer - or your

authorised representative
 the CE marking cannot be placed on products which are not covered by the
relevant European directives
 when attaching the CE marking, you take full responsibility for your product’s
conformity with the requirements of the relevant directives
 you must only use the CE marking to show the product’s conformity with the
relevant directives
 you must not place any marking or sign that may misconstrue the meaning or form
of the CE marking to third parties
 other markings placed on the product must not cover up the CE marking

Member states will ensure they implement the regime governing the CE marking. They will take
appropriate action in the event of improper use of the marking and provide for penalties for
infringements, which may include criminal sanctions for serious infringements. Those penalties will be
proportionate to the seriousness of the offence and constitute an effective deterrent against improper
use

The general principles of the CE marking are contained within Regulation (EC) No 765/2008 which
sets the requirements for accreditation and market surveillance relating to the marketing of products.
You can read the CE marking regulations on the Europa website.

CE marking image rules

Depending on the specifics of the directive that covers your product, you must make sure that:

 the initials ‘CE’ are in the standard, recognisable form

 if you reduce or enlarge the size of your marking the letters CE must be in
proportion to the standard version
 the CE marking is at least 5 millimetres - unless a larger minimum dimension is
specified in the relevant directive
 the CE marking is placed onto the product or to its data plate - if this is not
possible or not warranted because of the nature of the product, it must be placed onto the
packaging and accompanying documents
 the CE marking is easily visible, readable and permanent

Find example CE marking logos on the Europa website.

Keep documentation for CE marking

Please refer to the specific directives and/or regulations, and also our guidance documents.

You must keep certain documentation once you have placed the CE marking onto your product. This
information can be requested at any time by the Market Surveillance Authorities to check that
a CE marking has been legitimately placed on a product.

The information you must keep will vary depending on the specific directives relevant to your product.
You must keep general records of:

 how the product is manufactured

 how the product conforms to the relevant national standards
 addresses of manufacture and storage places
 design and manufacture of the product
 which New Approach Directives apply to the product and how they have been met
 European Community type-examination certificates, if applicable
You should keep the information in the form of a technical file which can be supplied if requested by
an enforcement authority.

The manufacturer’s Declaration of Conformity

The EC DoC is a document which may be required to accompany a product. In the document the
manufacturer, or his authorised representative within the EEA should:

 indicate that the product meets all the necessary requirements of the directives
applicable to the specific product
 make sure it has the name and address of the manufacturer together with
information about the product, for example brand and serial number

The DoC must be signed by an individual working for the manufacturer or his authorised
representative, and indicate the employee’s function.

CE marking enforcement

There are many bodies that enforce CE marking legislation to prevent misuse of the CE marking and
to ensure that product safety is maintained to a high standard.

Enforcement, or market surveillance, is undertaken by nominated public authorities (Market

Surveillance Authorities) in each member state, and each state has separate ways of enforcing the
legislation once it has been implemented into national law.

Market Surveillance Authorities and processes will vary depending on which directives are applicable
to your product. The following bodies, amongst others, are responsible for CE marking enforcement in
the UK:

 Trading Standards Services

 the Health and Safety Executive
 the Medicines and Healthcare products Regulatory Agency
 the National Measurement Office

If an enforcement body finds your product does not meet CE marking requirements, they will often
provide you with an opportunity to ensure it is correctly CE marked. If you fail to comply with this, you
will be obliged to take your product off the market. You may also be liable for a fine and imprisonment.

Further information

View the EC New Approach Directives guidance

CE marking guidance on the Europa website

View CE marking guidance for specific products from the Europa website

Product safety for businesses

CE marking logo examples on the Europa website

Published 8 October 2012

Last updated 31 December 2020 + show all updates

Rules for using the UKCA image

You must make sure that:

 if you reduce or enlarge the size of your marking, the let-

ters forming the UKCA marking must be in proportion to the
version set out below
 the UKCA marking is at least 5mm in height – unless a
different minimum dimension is specified in the relevant legis-
lation
 the UKCA marking is easily visible, legible
The UKCA marking can take different forms (for example, the colour
does not have to be solid), as long as it remains visible, legible and
maintains the required proportions.

Technical documentation and EU

declaration of conformity
The technical documentation provides information on
the design, manufacture, and operation of a product and must
contain all the details necessary to demonstrate the product conforms to
the applicable requirements.
If you are the manufacturer, there are certain rules that must be
followed when placing a product on the market; you must:
 prepare the technical documentation before placing a product on the
market
  ensure the technical documentation is made available to the market sur-
veillance authorities (should they request to see it) as soon as the
product is placed on the market
 keep the technical documentation for 10 years from the date the
product is placed on the market (unless explicitly specified otherwise)
The technical documentation is necessary to prove the product meets the
essential requirements and therefore justify and support an EU
declaration of conformity. You need this documentation in order to
affix the CE marking to the product.
How to draw up the technical
documentation?
The technical documentation should include at least:
 your name and address, or those of any authorised representatives

 a brief description of the product

 identification of the product, for example, the product's serial number

 the name(s) and address(es) of the facilities involved in the design and
manufacture of the product

 the name and address of any notified body involved in assessing the con-
formity of the product
 a statement of the conformity assessment procedure that has been fol-
lowed
 the EU declaration of conformity

 label and instructions of use

 a statement of relevant regulations to which the product complies

 identification of technical standards with which compliance is claimed

 list of parts

 test results

As a manufacturer, you should be able to demonstrate where and

how the various parts of the document are held and maintained.
You can usually choose in which language you want to prepare the
technical documentation. However, the market surveillance
authorities may ask you to translate the technical documentation
depending on the EU country where the product has been placed on the
market. If requested, you can also provide it in electronic format.
Risk assessment
As a manufacturer, you are responsible for identifying all the possible
risks your product could pose and determine the
applicable essential requirements. This analysis must be
included in the technical documentation. In addition, you will
need to explain the ways in which you have addressed the risks identified
to ensure that your product complies with the applicable requirements, for
example, by applying harmonised standards.
EU declaration of conformity
An EU declaration of conformity (DoC) is a mandatory document
that you as a manufacturer or your authorised representative need to sign
to declare that your products comply with the EU requirements. By signing
the DoC you take full responsibility for your product's compliance with
the applicable EU law.
How to draw up a declaration of conformity
As a manufacturer, it is your responsibility to draw up the EU
declaration of conformity (DoC). It should contain the following

information:
 your name and full business address or that of your authorised represent-
ative

 the product's serial number, model or type identification

 a statement, stating you take full responsibility

 means of identification of product allowing traceability – this can include

an image

 the details of the notified body which carried out the conformity assess-
ment procedure (if applicable)
 the relevant legislation with which the product complies, as well as
any harmonised standards or other means used to prove compliance
 your name and signature

 the date the declaration was issued

 supplementary information (if applicable)

For imported products, the importer must ensure that the product is
accompanied by the DoC and must keep a copy of it for 10 years after the
product has been placed on the market.
You must translate the EU declaration of conformity into the language or
languages required by the EU country in which your product is sold.

CE Mark – European Directives Product Certification in India

CE Marking is a declaration by the manufacturer that the product meets all the appropriate provisions
of the relevant legislation implementing applicable European Directives. CE Marking gives
companies easier access into the European market to sell their products without adaptation or
rechecking. The CE certification is applicable to the products like machines, pumps, valves, all
pressure equipment, electrical items and medical devices etc. The initials “CE” are declaration by the
manufacturer that his product meets the requirements of the applicable European Directive(s).

If you are a manufacturer, first assess the applicable Directive applies to your product. CE Marking
only applies to products within the scope of these Directives. It should not be applied to products, if
they are outside the scope of the Directives.

If you are manufacturer and are planning to export a product, which falls within the scope of the
markets in any of the member states of the European Union (EU) or European Economic Area (EEA)
then it is necessary that you apply for CE Marking of your products against the essential requirements
of all the applicable directives. Please note that CE Mark is a mandatory mark for most (around 70%)
of the products sold on the EU market (totaling 28 countries).

The New Approach Directives will provide a range of compliance routes for your product and show
you, usually in a modular format, the available routes to compliance. You must then decide which
route fits the best for your company set-up, and follow that route as detailed in the Directive. In many
cases the compliance route will require you to use a Notified Body to assist with your certification. The
essential requirements of the New Approach Directives differ from directive to directive and product to
product. If the new product directives apply to your products and you want to continue to export to the
European market (or introduce new products) then CE Marking will be crucial to your success.
Why CE Marking

The CE Mark is a conformity marking consisting of the letters CE. The CE Marking applies to products
regulated by certain European health, safety and environmental protection legislations. The CE
Marking is obligatory for products it applies to: the manufacturer affixes the mark in order to be
allowed to sell his product in the European market.

CE is an abbreviation for Conformity de European, French for European Conformity. The CE Mark
indicates that the product it is affixed to conforms to all relevant essential requirements and other
applicable provisions that have been imposed upon it by means of European directives, and that the
product has been subjected to the appropriate conformity assessment procedure(s). The essential
requirements refer, among other things, to safety, public health and consumer protection.
The CE Marking is not a quality mark. First, it refers to safety rather than to the quality of a product.
Second, CE Marking is mandatory for the product it applies to, whereas most quality markings are
voluntary.
CE Certification

The CE certification is a declaration by the manufacturer that the product meets all the appropriate
provisions of the relevant legislation implementing certain "European Directives". "CE Marking" gives
companies easier access into the European market to sell their products without adaptation or
rechecking. The initials "CE" do not stand for any specific words but are a declaration by the
manufacturer that his product meets the requirements of the applicable European Directives. In some
categories like PED and categories identified by EU, the assessment by third-party is required for CE
certification.
Steps for CE Certification Consultancy

For CE certification consultancy in India, Punyam management follows the below-mentioned steps,
which have so far given us 100% results of success while providing consultancy for various
manufacturing units in India for CE Marking on their products.

 Micro-level survey of your organization and gap analysis by our experts.

 Identifying applicable directive/s.

 Identifying harmonized standards.

 Testing of your product to ascertain, compliance with the requirements.

 Make a test report.

 Make Technical Construction file

 Prepare a technical file documenting compliance with the applicable requirements.

 Prepare and sign manufacturer's self-declaration of conformity.

 Apply for the CE Mark to the product.

 Declaration of conformity, prepare instruction booklet for safe use and maintenance.
Benefits of CE Certification

 With this "passport" your products can easily gain access to the entire European Union (EU)
and European Free Trade Association (EFTA) market.

 There will be only one set of laws and regulations for the entire marketplace which guide the
designing, manufacturing and labeling of products. The multiple and conflicting national re-
strictions on regulated products will be eliminated. Thus the CE Marking on your product will
make your trade with EU countries cheaper and easier.

 Your product will be made safer for consumers and thus the damage claims and liability
premiums will be reduced.
Requirements for CE Marking

1. CONTROLS ON PRODUCTS: Products subject to certain EC directives providing for CE

Marking have to be affixed with the CE Marking before they can be placed on the market.
2. APPLICABLE EU DIRECTIVES: Manufacturers have to check, on their sole responsibility,
which EU directives they need to apply for their products.

3. CONFORMITY ASSESSMENT PROCEDURE: The product may be placed on the market

only if it complies with the provisions of all applicable directives and if the conformity assess-
ment procedure has been carried out accordingly.

4. EC DECLARATION: The manufacturer draws-up an EC declaration of conformity and affixes

the CE Marking on the product.

5. THIRD-PARTY ASSESSMENT: If stipulated in the directive(s), an authorized third party must

be involved in the conformity assessment procedure.

6. USE OF LOGO: If the CE Marking is affixed on any product, the size of the CE Marking must
be at least 5 mm, if enlarged its proportions have to be kept. It can bear additional markings
only if they are of different significance. Do not overlap with the CE Marking so that it is not
confusing and do not impair the legibility and visibility of the CE Marking.