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 delve into the complexities of regulatory compliance in the European Union, unraveling the confusion between the “CE Certificate” and the “Declaration of Conformity.”
CE Certificate
La prevalencia del término «Certificado CE» ha causa constante confusión entre emprendedores e importadores que buscan cumplir con las normativas europeas. Es imperativo comprender que este «certificado» no existe en sí mismo; su origen radica en la interpretación equivocada del marcado CE. Antes de abordar las sutilezas entre el certificado CE y la declaración de conformidad, es esencial explorar el paisaje del cumplimiento normativo europeo. Desde los Reglamentos hasta las Decisiones, cada pieza de legislación forma un tapiz que debe entenderse meticulosamente para evitar obstáculos legales y garantizar una entrada exitosa al mercado europeo.
Esta confusión y el uso del termino Certificado CE, a pesar de no ser 100% correcto, es plenamente aceptado y utilizado incluso en los ámbitos profesionales. Vamos a examinar los dos conceptos que han dado lugar al termino Certificado CE
Declaration of Conformity
The Declaration of Conformity is a fundamental document, giving the manufacturer the responsibility of ensuring that their product complies with the rigorous requirements of the EU. From its drafting to its implementation, it highlights its relevance in demonstrating the regulatory integrity of the product.
This EU declaration of conformity could not exist without the conformity assessment, which is a process that determines whether a product complies with European standards. From choosing between an internal assessment and the involvement of a notified body, to preparing a solid technical file. It is very important to note that this document does not grant conformity to the product on its own; this document is part of a much broader file known as technical documentation. You can read our related article on product technical documentation. here.
CE Marking
The famous CE marking 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 a fundamental requirement. To obtain the CE marking for our product, the first thing we must do is analyze the applicable regulations to determine the path we must follow.
Conformity Assessment: Internal or with a Notified Body? The choice between an internal assessment and the intervention of a notified body does not depend on us as manufacturers, but on the regulations applicable to each product.
Technical File: The creation of a solid technical file is essential to support product conformity. Whether conformity is declared through internal production assessment 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 an external assessment by a notified body must be carefully determined. This is where we must refer to the specific regulations for each product in order to determine whether or not the intervention of a notified laboratory is required. Once the product and regulations have been studied and all mandatory requirements have been met, we can declare our product compliant and affix the CE marking.
Does my product require CE marking?
The CE marking is an essential requirement for marketing certain types of products. It is not possible to answer this question in a generic way, and we must always refer to the regulations applicable to each product. However, there are certain categories of products that require this marking and a conformity assessment prior to it.
Toys: All toys intended for children under 14 years of age must bear the CE marking 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 marking under EU Regulation 305/2011.
Personal Protective Equipment (PPE): Devices used to protect the safety or health of persons, such as face masks, must bear the CE marking in accordance with EU Regulation 2016/425.
Medical Devices: Under Directive 93/42/EEC, products intended for the diagnosis, prevention, monitoring, or treatment of diseases require the CE marking.
Boilers: New hot water boilers fueled by liquid fuels must bear the CE marking in accordance with Directive 92/42/EEC.
Explosives for Civil Use: Products considered explosives by the “United Nations Recommendations” must bear the CE marking in accordance with Directive 2014/28/EU.
Active Implantable Medical Devices: Any product intended to be introduced into the human body through medical intervention requires CE marking under Directive 90/385/EEC.
Recreational Craft: Various types of recreational craft and engines must bear the CE marking in accordance with Directive 2013/53/EU.
Elevators: Elevators in permanent operation in buildings must obtain CE marking in accordance with Directive 2014/33/EU.
Pressure Equipment: Pressure vessels, pipes, and fittings must bear the CE marking in accordance with Directive 2014/68/EU.
Some categories on this 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 baby cushions or foot products are considered medical devices.
That is why at Zertify & Comply, we strive to influence as much as possible the detailed study of each case, since it is by going into the details of each Regulation and Directive that we find the answers for most products. If you have any questions about your declaration of conformity or CE marking, please contact us and we will be happy to help you.
