Top Facts About CE Marking
CE mark is a certification mark which ensures conformity to regulations and rules of safety, health and environmental aspects of products sold in the EEA (European Economic Area). CE mark is thus a symbol, declaration, proof and validation with respect to Europe.
What does it stand for?
CE Mark appears on many products traded in the EEA. It can be seen on technical equipment, electronics, and toys and also on medical devices.
Basically, the CE mark serves the purpose of indicating that products sold in the EEA have been evaluated to meet stringent environmental protection, safety and health requirements. Another fact about the CE mark is that CE marking supports fair competition by holding all companies accountable as per the same rules.
How to obtain?
For gaining CE Marking certification, one must comply with European Commission Regulations (EU), No. 2017/745, commonly referred to as the MDR (Medical Device Regulation).
This simply implies that you must construct a technical file as proof that your product complies with all EU regulations. If you are a medical device manufacturer, it’s your responsibility for declaring compliance with all needs.
In case of all devices, except Class 1 (Self-certified), the company must implement a QMS (Quality Management System) as per the MDR.
Generally, the CE mark is supposed to be imprinted on the product. But if this is not possible, then manufacturers are allowed to affix it on packaging material or data plate of the product.
Why is CE mark vital?
The CE Marking is important for several reasons. It is a legal responsibility. It comes from EU legislation. It guarantees that the product is conforming to stipulations of the EEA. Selling products without CE Mark is an economic offence which is punished differently by each of the EU member states.
CE marking indicates that the product is free to enter the EEA. CE mark is mandatory for all products that are imported or exported from EEA. The manufacturer shall affix the CE marking to products but must take some obligatory steps before using it.
By affixing the CE mark, the manufacturer takes total responsibility of the products for complying with rules and standards of the EU (European Union). This CE mark has helped the EU to improve product quality.
Is it a passport to Europe?
The CE marking certification amounts to a passport for a product to enter the EU market. The CE marking procedure enables the free movement of a product within the EU. For several consumers, it is a symbol of quality.
What does it indicate?
A CE mark is a symbol that must be affixed on products before they can be sold in the EU. This mark indicates that a product serves the needs of relevant European directives for products. Also, it ensures that it meets all the needs of applicable, recognised and harmonised European performance and safety standards. It indicates that the product is fit for its objectives and will not jeopardise property or lives.
- CE marking certificates are usually valid for a maximum of 5 years but maybe reviewed annually.
- CE is an abbreviation of a French term- Conformité Européene’ which means European Conformity.
These are all the top facts about CE marking.