This process acts as a safeguard, ensuring that the products comply with the essential requirements of safety, health, environment and consumer protection before entering the EU market. This article delves into the process of conformity assessment in the EU, explaining the responsible parties, the different methods used and how manufacturers can navigate this crucial step towards accessing the market.
Compliance with regulations is not only a legal requirement, but a crucial tool to compete effectively in the market, as the consumer confidence in the safety and quality of the products, it is essential for success.
Responsibility of the manufacturer
The responsibility for the evaluation of compliance ultimately rests with the manufacturer. They are required to carry out the procedures necessary to ensure that their products comply with the stipulated requirements, even if you outsource the design or production. This includes performing a risk analysis of a comprehensive product, to identify potential hazards and implement the measures needed to mitigate them.
As we have already seen in other articles of the blog, the european regulation in its greater part, as well as the new General Regulation (article here), identifies the manufacturer as the operator marketing, design, or send design to a product under your own brand or trade name.
You should not neglect the compliance to marketing a product. It is not for nothing strange, and in fact we can see this in the portal Safety Gate of the EU (https://ec.europa.eu/safety-gate-alerts/screen/webReport), such as daily are removed dozens of products for any type of non-compliance.
Understanding of the Assessment of Conformity
The conformity assessment is a process of verification that demonstrates that a product complies with the applicable law, before it can be put on the market. Is carried out before introducing the product in the market and continues to do for your marketing, covering both phases of design and production.
This proactive approach ensures that we identify and address potential security issues from the initial concept to the final product manufactured.
It's going to be the law itself, on the basis of the risks associated with the product, we indicate which mode of proceeding, and the path to follow in order to declare conformity of our product:
Internal Control of Production
Gives manufacturers the experience and quality management systems to self-assess their products on the basis of the relevant requirements of the EU. This method is typically suitable for categories of products to be of lower risk.
Relevant aspects of the internal production control:
- Establishment of a Quality Management System: The manufacturers create a documented system that describes processes for the control of design, production control, final product inspection and testing. This system ensures a consistent quality and compliance with the relevant standards throughout the life cycle of the product.
- Assessments of Conformity: The manufacturers perform evaluations based on harmonised standards, voluntary technical specifications that are presumed to comply with the essential requirements, or other technical specifications. These assessments may be carried out, for example, by conducting laboratory tests.
- Compilation of a Technical File: The manufacturer collects all the relevant information throughout the process in a technical file. This record typically includes details on the design of the product, the production process and the activities of conformity assessment carried out. We have a full article on the technical dossier here.
- Issuance of a Declaration of Conformity: Finally, the manufacturer issues a declaration of conformity, in which you assume full responsibility for the compliance of the product with all applicable requirements of the EU.
Involvement of a Notified Body
For products of a higher risk or when the complexity of the assessment requires external experience, the regulations may require the involvement of a notified body. These are independent organisations designated by the member States of the EU to assess the conformity.
Si el producto en cuestión es de los que debe ser evaluado con la intervención de un organismo notificado, el fabricante deberá de acudir a uno de ellos, los cuales se encuentran públicamente listados en el sitio web NANDO (https://webgate.ec.europa.eu/single-market-compliance-space/#/home).
It will be the rules which you detail meticulously in the extent to which it should intervene this agency, which once you have made your assessment, it shall issue a certificate of conformity will serve the manufacturer to make the declaration of conformity by reference to the certificate of the notified body.
This control to perform the certification by the notified body, may only be limited to certain aspects of the product or some of its features. You should carry out a detailed study of the applicable laws and regulations, to know the detail of which will be the intervention of these entities.
The conformity assessment is a fundamental process to demonstrate that a product complies with the applicable legislation before being marketed. Manufacturers have the responsibility to conduct a thorough analysis of the risks associated with the product, identifying potential dangers and taking the necessary measures to mitigate them. In addition, they must compile a technical file that document the design, the production, the tests conducted and the assessment of risks. This record must be available to the market surveillance authorities and kept for a specific period, usually ten years after the marketing of the product.
In Together Comply, we have accompanied more than a hundred companies and entrepreneurs, in the process of conformity assessment of their products, performing from the technical documentation and studies are normative, to the advice in the choice of a notified body or suitable laboratories.
The european regulation is overwhelming and we are here to make it understandable, because a good tip guarantees a good result. If you have any doubt about the compliance of your product, please contact with us and we will be happy to help you.
