Abstract / Resumen
The confusion over CE markings goes back a long way. However, during the last year, with the sharp rise in importing medical devices, this problem has become increasingly noticeable, as the CE (Conformité Européenne) marking for this category of products has been compulsory since it came into force in 1993.
The European CE marking is a guarantee of quality. It means that the product complies with the safety, health and environmental protection requirements of the European Union. This label indicates that the manufacturer has assessed the product responsibly and ensures that it meets the necessary obligations in order to be sold within the EU.
By contrast, the Chinese CE mark (from the acronym China Export), only indicates that the product has been manufactured in China and is equivalent to the “made in China” labels that we usually see on imported fashion products.
How to differentiate between the two CE labels?
It is evident that the logos of both brands are practically identical in terms of typography, composition and colour (black), which, at first glance, makes it incredibly difficult to differentiate one from the other.
Despite their similarity, the position, or more precisely, the separation between the initials gives us the clue as to which marking we are looking at. On the European label, the inner circumference of the C is noticeably separated from that of the E. On the China Export label, by contrast, the arcs formed by the letters practically overlap as they are very close together.
Although there are no established measurements for the size of the European CE marking, the regulations state that this logo must be 5mm in height minimally and keep an established proportion.
When is the European CE marking mandatory for my imported products?
CE marking is only mandatory for certain types of products for which EU specifications exist. Affixing the CE marking is compulsory for these products. The list is quite extensive, and some of these products have certain exceptions for which full information can be found in the Blue Guide on the application of EU product legislation.
- Construction products
- Personal Protective Equipment
- Sanitary Products
- Explosives for civilian use
- Active implantable medical devices
- Recreational crafts
- Pressure equipment
- In vitro diagnostic medical devices
- Radio and communication terminal equipment
- Cableway installations for people transportation
- Measuring instruments
- Electrical and Electronic Devices
- Low voltage products
- Pyrotechnic articles
- Weighing instruments
- Simple pressure containers
- Gas appliances
The CE marking must be visible, legible and not confusing on all products that must bear the CE marking. It must have been affixed to the product before it enters the target market and, where a certain body has been involved in production control, the CE symbol must be followed by the identification number of this body.
Import quality controls; the key to quality control.
Quality controls are essential to avoid any surprises when importing from China, or any other Asian country.
As we expressed at the beginning of this article, the European CE marking only indicates that the manufacturer claims to have passed the required quality controls but is not definitive proof. In many cases this is true. But not always. For this reason, independent quality controls are vitally important.
It is, therefore, prudent to carry out voluntary inspections of the products we have ordered to be manufactured. These controls are an excellent way to complement and ensure the correct functioning of mandatory inspections.
Inspections by the client help to ensure that the product is being manufactured as intended. Similarly, they allow us to check quality details and ensure that the products comply with the quality standards of the country of final destination and that they can be marketed without problems in accordance with the CE marking (if the product needs it) or the national regulations.
At S3 Group we have more than 15 years experience as a sourcing partner specialising in products manufactured in Asia. Our work encompasses many services, but our goal is always the same. That is to ensure that importing is successful and, of course, this means that the products purchased are of the desired quality, regardless of their brands or labels.