CE markings

Many products require CE marking before they can be sold in the EU. CE marking indicates that a
product has been assessed by the manufacturer and deemed to meet EU safety, health and
environmental protection requirements. It is required for products manufactured anywhere in the
world that are then marketed in the EU.

Products needing CE Marking

CE marking is mandatory for products covered by the scope of the New Approach Directives. Even
product(s) manufactured outside the European Economic Area (EEA) must bear the CE Mark if they
are going to be sold within the EU. Some major regulations concerning CE marking are
1. Low Voltage Directive (2014/35/EU)
2. The European Pressure Equipment Directive (PED) 2014/68/EU
3. Machinery Directive (2006/42/EC).
4. The EMC Directive (2014/30/EU)
5. Electromagnetic Compatibility (EMC) Directive
6. PPE Regulation (EU) 2016/425.
7. ATEX Manufacturers Directive 2014/34/EU
CE marking applies to products ranging from electrical equipment and toys to medical devices and
more. Here is a complete list of these product categories according to:
https://www.gov.uk/guidance/ce-marking.

CE Markings Process
Follow the flowchart below and your road to CE marking will be smooth and fast.

Step 1: Identify the applicable Directive(s)

The first step is to identify whether your product can be CE marked or not. Not all products are
required to be CE Marked, only the products that fall within the scope of at least one of the CE
Marking Directives. There are more than 20 product Directives & Regulations covering a range of
products. Such products includes (but not limited to) electrical equipment, machines, medical devices,
toys, pressure equipment, PPE, wireless devices and construction products.

Step 2: Identify the applicable requirements of the Directive(s)

Each Directive has slightly different methods of demonstrating conformity. This usually depends on
the classification of the product and its intended use. Every  has a number of ‘essential requirements’
which the product has to meet. The best way to demonstrate that these essential requirements have
been met is by meeting the requirements of applicable ‘harmonised European Norms’ (Standard)
known as hENs. Standards may offer a presumption of conformity to the essential requirements of the
applicable Legislation. However do not forget that the use of standards usually remains voluntary.
hENs can be identified by searching the ‘official journal’ on the European Commission’s website.

Step 3: Identify an appropriate route to conformity

The CE Marking process is always a self-declaration process however you may need to involve a
third party. This is set out in the ‘system of attestation’ and will vary between Directive. Some
products (such as invasive medical devices or fire alarm systems) may, to some extent, have a
mandatory requirement for some involvement of an authorised third party.
Step 4: Assessment of the product’s conformity
When all of the requirements have been established, you need evidence that the product meets the
essential requirements of the Directive(s). This usually involves some assessment and/or testing. It
will often involve ensuring that the requirements of the applicable harmonised standard(s), which
were identified in step 2, have been met.
Step 5: Compile the technical documentation
Technical documentation relating to the product or range of products needs to be compiled. This
information should cover every aspect relating to conformity and is likely to include details of the
design, development and manufacture of the product. Technical documentation may also be known as
the Technical File or Technical Construction File.
 Technical description.
 Drawings, circuit diagrams and photos.
 Bill of materials.
 Specification and, where applicable, Declarations of Conformity for the critical components
and materials used.
 Details of any design calculations.
 Test reports and/or assessments.
 Instructions.
 Copy of the Declaration.
Technical documentation can be made available in any format (i.e. paper or electronic) and must be
held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in
the European Economic Area (EEA).

Step 6: Make a Declaration and affix the CE Mark

When the manufacturer, importer or authorised representative is satisfied that their product conforms
to the applicable CE Marking Directives, they must complete a Declaration. Under most Directives it
is known as the EU Declaration of Conformity but other terms exist. Such as Declaration of
Incorporation for partly completed machinery and Declaration of Performance for construction
products.

Do you need an independent assessment?

You need to check if your product has to be tested by a notified body. You can find this information
in the relevant legislation applicable to your product: check the rules by product category.
This step is not obligatory for all products.
If you need to involve a notified body, the CE marking must be accompanied by the identification
number of the notified body. The CE mark and the identification number can be affixed separately, as
long as they appear clearly linked to each other. You can use the Nando database to search for a
notified body that can certify your product.
If your product doesn't need to be verified by an independent body, then it is up to you to check
that it complies with the technical requirements. This includes estimating and documenting the
possible risks when using your product.