The CE marking is a label that we are used to seeing on products, but what does it mean and what is it for consumers? In the following report, we teach you to know what it is like and how it is interpreted.

The CE marking is a symbol by which the manufacturer or legally responsible party declares under its responsibility that the product it is marketing, after carrying out an evaluation procedure, has complied with the essential health and safety requirements that are included in the regulation . corresponding to the product.

It is not a brand of origin. In other words, it does not mean that it has been manufactured in the European Union , hereinafter the EU, but that the product sthat has been placed on the EU market complies with European safety legislation.

It affects products that have a directive that defines specific design, safety, and manufacturing requirements.

The CE marking is mandatory , except for products that do not have a directive, called new approach directives, that regulates them and that requires that the product must include the CE marking. The moment in which it must be placed is just before it is placed on the market or put into service in the European Union.

It is independent of whether the product has an economic benefit or is free; and also independent of the sales technique, both in catalog and in electronic commerce, as long as the final market is the EU.

It is mainly the responsibility of the manufacturer, but also part of the responsibility of the representative, importer and distributor. Everyone has to ensure that they put a safe product on the market for the end user.

Legislative framework

The objective of the CE marking is that everyone plays by the same rules, both manufacturers and end users. It must be taken into account that we are placing products in a market made up of 27 different countries , with 27 laws , and the idea is to unify criteria . Therefore, both technical and regulatory harmonization is sought.

For this, the New Approach Directives were created for certain products, which establish safety requirements that are the same in all countries; as well as a common technical environment that guarantees the confidence that the tests carried out in any of these countries have the same validity.

The products that must bear the MDR CE Marking are those established in the New Approach Directives, whose origin is Regulation 765/2008 and Decision 768/2008 , which include the evaluation procedures.

The list of products affected by New Approach Directives is included in this link.

If the CE marking is placed on a product that does not have a New Approach Directive, it will be considered misleading to the consumer, as the consumer may think that the product meets legal requirements that do not actually exist. This does not mean that it should not comply with any regulations, since any product that can be purchased by a consumer in the EU must comply with Directive 2001/95/CE , relative to the general safety of products.