A CE mark logo is an essential identification for certain products in the EU, including medical devices. There are different ways to obtain a CE marking for the different products available on the market.
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA), but is also found on products sold elsewhere that have been manufactured to EEA standards.
The mark indicates that the product may be traded freely in any part of the European Economic Area, regardless of its country of origin. It consists of the CE logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. "CE" is the abbreviation of "conformité européenne" (French for "European conformity").
The steps for CE mark:
Stage 1: Identify the applicable norm(s)
The first step is to identify whether the product needs to bear CE marking or not. Not all products are required to bear CE marking, only the products that fall within the scope of at least one of the sectoral norms (directives and regulations) requiring CE marking. There are more than 20 sectoral product norms requiring CE marking covering, but not limited to, products such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products.
Stage 2: Identify the applicable requirements of the norm(s)
Each norm has slightly different methods of demonstrating conformity depending on the classification of the product and its intended use. Every Directive or Regulation has a number of 'essential requirements' that the product has to meet before being placed on the market. The best way to demonstrate that these essential requirements have been met is by meeting the requirements of an applicable 'harmonised standard,’ which offer a presumption of conformity to the essential requirements, although the use of standards usually remains voluntary.
If a medical device, identify the Essential Requirements or General Safety and Performance Requirements.
Stage 3: Identify an appropriate route to conformity
The process is not always a self-declaration process, there are various 'attestation routes' to conformity depending on the Directive or Regulation and classification of the product. Many products (such as invasive medical devices, or fire alarm and extinguisher systems, pressure equipment, lifts etc.) in most cases, have a mandatory requirement for the involvement of an authorised third party e.g. a "notified body" also called just NB.
There are various attestation routes which include:
An assessment of the product by the manufacturer (self-declaration process)
An assessment of the product by the manufacturer, with additional requirement for mandatory factory production control audits to be carried out by a third party. (NB process)
An assessment by a third party (e.g. EC type test), with the requirement for mandatory factory production control audits to be carried out by a third party. (NB process)
Stage 4: Compile the technical documentation
When all of the requirements have been established, the conformity of the product to the essential requirements of the norm(s) needs to be assessed. The technical documentation requirements will change according to the standard applied.
Stage 5: Make a declaration and affix the CE marking
When the manufacturer, importer, Notified Body or authorised representative is satisfied that their product conforms to the applicable norms, an EU declaration of conformity must be completed, the CE mark can be affixed.
This process can be used for the following devices:
medical devices
invitro diagnostic 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
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