The process of CE Marking

The CE marking regime in the European Union (EU) is well established and mandatory in the twenty seven member states.

Step One

We will determine the directive(s) applicable to your product; it is worthy of note that more than one directive can apply to a single product, and that a Directive can refer to other directives which must be met.

The current product categories and respective directives that require CE Marking are:

Low voltage electrical equipment (LV)
Equipment with electromagnetic emission (EMC)
Personal protective equipment
Explosives for civil uses
Equipment and protective systems for use in explosive atmospheres
Radio and telecommunications terminal equipment
Medical devices
Machinery
Toys
Construction products
Non-automatic weighing instruments
Active implantable medical devices
Gas appliances
New hot water boilers
Recreational craft
Lifts
Pressure equipment
Cableway installations designed to carry passengers
Measuring instruments
Simple pressure vessels

If your product falls into any of the categories listed above, you are responsible for ensuring that all the relevant requirements set out in the relevant directives are met, this will include issuing a signed Decalaration of Conformity (DoC) a legal statement that the product conforms with the Directive(s)

Step 2

Your product will need to go through the ‘Conformity Assessment Procedure’ chart (Annex 8 of the European Commissions Guide, in order to understand the requirements relating to your product.)

This classifies the level of risk for your product, which depends on the directive, and prepares you for the external assessment process. TRaC can determined and review the applicable directives your product must comply with to address the essential requirements, for design and manufacturing.

The conformity assessment procedure consists of eight modules, which represent the various phases that relate to the design and production stages of a product. Products of greater 'risk' attract more modules of conformity assessment to ensure the item is safe.

The modules are:

Module A: Internal Control of Production (during design and production phases – this module does not require a notified body to take action)
Module B: EC Type Examination (during the design phase)
Module C: Conformity to Type (during production phase)
Module D: Production Quality Assurance (during production phase)
Module E: Product Quality Assurance (during production phase)
Module F: Product Verification (during production phase)
Module G: Unit Verification (during design and production phases)
Module H: Full Quality Assurance (during design and production phases)

Step 3

Identify the relevant conformity assessment procedures at this point you will require an independent assessment of conformity, laboratory such as TRaC.

Why choose us for this service:

Competitive Pricing
Free consulting services
State of the art facilities
Our certifications are recognized worldwide
Secure test facilities that are security cleared and approved under Section 5 of the Firearms Act
Secure large compound for safe storage of vehicles.
Security Cleared engineers.
Customers’ work and recreation space.

Step 4

We will put together a technical report that verifies the testing was conducted properly and standards have been met.

Technical Report will cover:

the design, of the product
manufacture of the product
operation of the product
Information on your suppliers.

The level of detailed information included in this file depends on the directive and the nature of the product.

Technical documentation is very important information that should be readily available on request.

Step 5

We will then help prepare The Declaration of Conformity, containing all the necessary information that will allow authorities to trace the product back to its manufacturer or representative in Europe and serves as an official declaration as part of the technical file.

This declaration includes:

Product identification (name, type or model number, serial number etc)
Directives complied with
Standards used
Name of the laboratory and or Notified Body (TRaC)
Manufacturer’s contact details and signature

Step 6

Once this process is complete you are able to affix the CE Mark on your product in accordance with the Directive. There are rules regarding the size and location of the marking, these should be considered before you take this final step.

Affixing 'CE' is the responsibility of the manufacturer or their authorised representative within the EU

Once affixed the product can be placed on the EU market and offered for sale, in the knowledge that the Declaration of Conformity (DoC) is backed by dependable and repeatable est results and controlled build standard.