In the intricate world of international trade, regulatory compliance european stands as a key challenge, particularly when you import products from outside the European Union. This article will plunge into the complexities of regulatory compliance in the European Union, unravels the confusion between the "CE Certificate" and the "Declaration of Conformity".
CE certificate
The prevalence of the term "CE Certificate" has caused constant confusion between entrepreneurs and importers who seek to comply with the european regulations. It is imperative to understand that this "certificate" does not exist in itself; its origin lies in the erroneous interpretation of the CE marking. Before addressing the subtleties between the CE certificate and the declaration of conformity, it is essential to explore the landscape of regulatory compliance european. Since the Regulations until the Making, each piece of legislation form a tapestry that is to be understood thoroughly to avoid legal obstacles, and to ensure a successful entry to the european market.
This confusion and the use of the term CE Certificate, despite not being 100% correct, it is fully accepted and used even in professional fields. Let's examine the two concepts that have given rise to the term CE Certificate.
Declaration Of Conformity
The Declaration of Conformity is held as a fundamental document, giving the manufacturer's responsibility to ensure that your product complies with the rigorous requirements of the EU. From its writing to its implementation, highlighting its relevance in the demonstration of the integrity rules of the product.
This statement EU conformance, could not occur if the conformity assessment is a process that determines whether a product complies with the european standards. Since the choice between an internal assessment and the involvement of a notified body, to the preparation of a technical dossier solid. It is very important to note that this document does not give you the conformity of the product by itself, this document forms part of a dossier that is much broader than we know them for technical documentation. You can read our article related to the technical documentation of product here.
CE marking
The famous CE marking, is no more than the symbol CE that so many times we have seen in hundreds of products. The responsibility of the manufacturer to ensure the conformity of the product with the requirements of the EU is presented as a fundamental requirement. To obtain the CE mark on our product, the first thing we need to do, is to analyze the regulations applicable to the same, to determine the road that we must follow.
Conformity assessment: What 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 the manufacturer, if not of the regulations to the effect of each product.
Technical File: The creation of a technical dossier solid is essential to support the conformity of the product. Declared the conformity assessment procedures of the internal production or through the intervention of a notified body, the preparation of the technical file is a critical requirement for the conformity of our product.
Detailed evaluation of the Need of a Notified Body: The need of an external assessment by a notified body must be determined carefully. And it is here where we must go to the specific rules of each product, in order to determine if they are required or not, the intervention of a laboratory notified. After the study of the product, the rules and done everything required, we can declare our product as in accordance with and estamparle the CE marking.
Does my Product Require CE Marking?
The CE marking is an essential requirement to be able to market certain types of products. There is No single answer to this question in a generic way, and we must always refer to the regulations to the effect of each product, however, that there are certain product categories that require marking and evaluation of conformity, upon the same.
Toys: All toys intended for children under the age of 14 years must bear the CE Marking in accordance with the directives 88/378/EEC and 2009/48/EC.
Building products: Those designed to be incorporated permanently construction works, such as metal structures, they must obtain the CE Marking under the Regulation (EU) 305/2011.
Personal Protective equipment (PPE): The devices used to protect the health or safety of persons, such as facial masks, must bear the CE Marking according to the EU Regulation 2016/425.
Health Products: Under the Directive 93/42/EEC, the products intended for the diagnosis, prevention, monitoring or treatment of diseases require the CE Marking.
Boilers: The new hot-water boilers fired with liquid fuels must bear the CE Marking according to Directive 92/42/EEC.
Explosives for Civilian Use: Products considered to be explosive for the "Recommendations of the United Nations" must bear the CE Marking according to Directive 2014/28/EU.
Active Implantable Medical Devices: Any product intended to be introduced into the human body through medical intervention requires the CE Marking under the Directive 90/385/EEC.
Pleasure craft: Various types of recreational boats and motors must bear the CE Marking according to Directive 2013/53/EU.
Elevators: Lifts permanently serving buildings must obtain the CE Marking according to Directive 2014/33/EU.
Pressure equipment: Containers, pipes and fittings for pressure purposes must bear the CE Marking according to Directive 2014/68/EU.
Perhaps some categories of such listing may seem strange, but they are more common than we might think. For example, a carabiner climbing or swimming goggles, are considered as personal Protection Equipment, like certain cushions for babies / products for the feet, are considered as health products.
It is for this reason that from are in the right place, at Together Complywe strive to influence everything in the in-depth study of each case, whether that is by going into the detail of each Regulation and Policy, where we find the answers to most of the products. If you have any doubts about your declaration of conformity or CE marking, please contact us and we will be happy to help you.
