Product compliance upon import

In the intricate world of international trade, European regulatory compliance stands as a crucial challenge, particularly when importing products from outside the European Union. This article will dive into the complexities of regulatory compliance in the European Union, unraveling the confusion between the “CE Certificate” and the “Declaration of Conformity”.

CE certificate

The prevalence of the term “CE Certificate” has caused constant confusion among entrepreneurs and importers seeking to comply with European regulations. It is imperative to understand that this “certificate” does not exist in and of itself; its origin lies in the wrong interpretation of the CE mark. Before addressing the subtleties between the CE certificate and the declaration of conformity, it is essential to explore the European regulatory compliance landscape. From Regulations to Decisions, each piece of legislation forms a tapestry that must be meticulously understood to avoid legal obstacles and ensure successful entry into the European market.

This confusion and the use of the term CE Certificate, despite not being 100% correct, is fully accepted and used even in professional fields. We are going to examine the two concepts that have given rise to the term CE Certificate.

Declaration of Conformity

The Declaration of Conformity stands as a fundamental document, giving the manufacturer the responsibility to ensure that their product meets the strict requirements of the EU. From drafting to implementation, highlighting its relevance in demonstrating the regulatory integrity of the product.

This EU declaration of conformity could not be given if the conformity assessment is a process in which it is determined if a product complies with European standards. From the choice between an internal evaluation and the participation of a notified body, to the preparation of a solid technical file. It is very important to note that this document does not grant conformity to the product by itself, this document is part of a much larger file that we know from technical documentation. You can read our related article on technical product documentation hither.

CE marked

The famous CE mark is nothing more than the CE symbol that we have seen so many times on hundreds of products. The manufacturer's responsibility to ensure product compliance with EU requirements is presented as a fundamental requirement. To obtain the CE mark on our product, what we must first do is analyze the regulations applicable to it, to determine the path we must follow.

Conformity Assessment: Internal or with a Notified Body? The choice between an internal evaluation and the intervention of a notified body does not depend on us as manufacturers, but on the regulations for the purpose of each product.

Technical Record: Creating a strong technical record is essential to support product compliance. Whether conformity is declared by internal production evaluation procedures or through the intervention of a notified body, the preparation of the technical file is a fundamental requirement for the conformity of our product.

Detailed Assessment of the Need for a Notified Body: The need for external evaluation by a notified body must be thoroughly determined. And this is where we must go to the specific regulations for each product, in order to determine if the intervention of a notified laboratory is required or not. Once the product has been studied, the regulations and everything mandatory has been carried out, we can declare our product as compliant and give it the CE mark.

Does My Product Require CE Marking?

CE marking is an essential requirement to be able to market certain types of products. This question cannot be answered in a generic way and we must always refer to the regulations for the purpose of each product, however, there are certain categories of products that require this marking and the evaluation of conformity, prior to it.

Toys: All toys intended for children under 14 years of age must bear the CE Mark in accordance with directives 88/378/EEC and 2009/48/EC.

Construction Products: Those designed to be permanently incorporated into construction works, such as metal structures, must obtain the CE Mark under EU Regulation 305/2011.

Personal Protective Equipment (PPE): Devices used to protect people's safety or health, such as face masks, must bear the CE Mark according to EU Regulation 2016/425.

Sanitary Products: Under Directive 93/42/EEC, products intended for the diagnosis, prevention, control or treatment of diseases require CE Marking.

Boilers: New hot water boilers fired with liquid fuels must bear the CE Mark according to Directive 92/42/EEC.

Explosives for Civil Use: Products considered explosive by the “United Nations Recommendations” must bear the CE Mark according to Directive 2014/28/EU.

Active Implantable Health Products: Any product intended to be introduced into the human body through medical intervention requires the CE Mark under Directive 90/385/EEC.

Recreational Boats: Various types of recreational and motor boats must bear the CE Mark according to Directive 2013/53/EU.

Elevators: Elevators in permanent operation in buildings must obtain the CE Mark according to Directive 2014/33/EU.

Pressure Equipment: Containers, pipes and fittings subject to pressure must bear the CE Mark in accordance with Directive 2014/68/EU.

Perhaps some categories on that list may seem strange to you, but they are more common than we might think. For example, a climbing carabiner or swimming goggles are considered Personal Protective Equipment, just as certain cushions for babies or foot products are considered as medical devices.

This is why since Together Comply, we try to influence as much as possible the detailed study of each case, since it is by going into detail of each Regulation and Directive, that we find the answers for most of the products. If you have questions about your declaration of conformity or about the CE mark, contact us and we'll be happy to help.