WHAT DOES

THE CE
MARKING
PROCESS
LOOK LIKE?
Overview of what all manufacturers, importers and
distributors should do to obtain CE marking
The CE marking process

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Identify the applicable 1 6 Affix the CE marking

directive(s) and and draw up the
harmonised standards Declaration of Conformity

Draw up and
Verify product
keep available
specific 2 5
the required
requirements
technical file

Identify whether an independent Test the product and

conformity assessment (by a 3 4 check its conformity
notified body) is necessary
1. Identify the applicable directive(s) and harmonised standards

How do you know if your product requires a CE mark? The first step is to see if your product is
covered under one or more of the CE directives. Although the directives change every now and
then, as does the website of the European Commission, here are some addresses where you
might find the full list (if not, send an email to cemarking@instrktiv.com ):
yy https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en
yy https://en.wikipedia.org/wiki/CE_marking

Each directive gives requirements on what the EU legally requires for your product to
comply. These requirements are formally referred to as “the Essential Safety and Health
Requirements” and are very general in nature. The directives do not detail how to design a
product in such a way that it meets the essential requirements, or what the user instructions
should look like. Harmonised standards describe in much more detail how you can technically
meet the requirements of the directives. Though harmonised standards are not mandatory,
by applying them you create the highest level of presumption of conformity with Essential
Requirements of the Directives.

Although the standards change every now and then, as does the website of the European
Commission, here is an address where you might find some standards by clicking on one of
the product groups:
yy http://ec.europa.eu/growth/single-market/european-standards/harmonised-
standards_en

Otherwise, search for standards on the websites of one of the standardisation institutes:
yy https://www.iso.org/
yy https://www.bsigroup.com/

2. Verify product specific requirements

Not each requirement in a directive or harmonised standard applies to each product. For
example, if your product is machinery but not handheld machinery, the requirements for
handheld machinery will not apply to your product. That’s why you should verify the directives
and harmonised standards for those requirements that apply to your product.

In many cases, manufacturers may rely on standards other than harmonized standards in
order to demonstrate compliance with the essential requirements in the directives. These can
be non-harmonised standards or industry standards.
3. Identify whether an independent conformity assessment (by a notified body) is
necessary

Some directives require products to be tested and certified by a third-party organisation,

or a so-called Notified Body, in order to ensure their conformity with the relevant essential
requirements. These directives (and regulations) include the Medical Devices Regulation, the
ATEX directive, the Pressure Equipment directive, the Gas Appliance directive, and the Simple
Pressure Vessels directive.

If applicable directives do not require the use of a Notified Body, manufacturers may
perform the conformity assessment themselves. In some cases, such as to comply with the
requirements of the Machinery Directive and Toy Directive, the only time a Notified Body is not
required is if the manufacturer uses a harmonized standard.

4. Test the product and check its conformity

How do you know that your product complies with the essential requirements in the applicable
directives? You will have to test and document that your product actually conforms. Each
directive outlines which conformity assessment procedures – also referred to as modules – a
manufacturer can undertake. There are 8 conformity assessment modules. The applicable
directives outline which module(s) apply to a particular product category.

Module A: Internal production control

Module B: EC type examination
Module C: Conformity to type
Module D: Production quality assurance
Module E: Product quality assurance
Module F: Product verification
Module G: Unit verification
Module H: Full quality assurance (EN ISO 9001)

5. Draw up and keep available the required technical file

All CE marking directives impose an obligation for the manufacturer to create and make
available a technical file (or technical documentation) containing information which
demonstrates that the product conforms to the requirements of the directive. A technical file
relevant to a CE-marked product must be kept for at least 10 years from the last date the
product was manufactured, unless the directive provides for a later date. The technical file
must be provided to enforcement authorities on demand, often within short timelines. The
technical file needs to be kept up to date, especially when the product is modified or is subject
to updated conformity assessment procedures.
Each directive has different requirements on what should be in the technical file. As an
example, the technical file for Low Voltage products should contain:
yy a general description of the electrical equipment;
yy conceptual design and manufacturing drawings and diagrams of components, sub-
assemblies, circuits, etc.;
yy descriptions and explanations necessary for the understanding of those drawings and
diagrams and the operation of the electrical equipment;
yy a list of the harmonised standards applied in full or in part, the references of which
have been published in the Official Journal of the European Union or international or
national standards referred to in Articles 13 and 14 and, where those harmonised
standards or international or national standards have not been applied, descriptions
of the solutions adopted to meet the safety objectives of this Directive, including a
list of other relevant technical specifications applied. In the event of partly applied
harmonised standards or international or national standards referred to in Articles 13
and 14, the technical documentation shall specify the parts which have been applied;
yy results of design calculations made, examinations carried out, etc.; and (f) test reports

6. Affix the CE marking and draw up the EU Declaration of Conformity (27 KB).

Once the technical file has been completed, as a manufacturer you can declare compliance
with the directives by drafting and signing the Declaration of Conformity (see here for DoC
templates). The Declaration of Conformity is an acknowledgement by the manufacturer that
they are responsible for the compliance of their products with the applicable directives. The
declaration should be available to authorities at the EU point of entry. The Declaration of
Conformity generally includes the following:
yy who you are
yy what product it refers to
yy what directives are involved
yy which standards have been used
yy where test results can be found
yy who is responsible in your company

What’s next?
yy Do you want to know how you can develop a compliant user manual and decrease your
liability? Download the Process on how to create compliant user manuals!
yy Do you want to know how to identify the directives that apply to your product?
Contact us!
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