Conformity assessment: Keys to evaluating and declaring the CE conformity of your product.

This process acts as a safeguard, ensuring that products meet essential safety, health, environmental and consumer protection requirements before entering the EU market. This article delves into the conformity assessment process in the EU, explaining the responsible parties, the different methods employed and how manufacturers can navigate this crucial step towards market access.

Regulatory compliance is not only a legal requirement, but a crucial tool to compete effectively in the market, since consumer confidence in the safety and quality of products is essential to success.

Manufacturer's liability

The responsibility for the conformity assessment ultimately lies with the manufacturer. They are required to carry out the necessary procedures to ensure that their products meet the stipulated requirements, even if they outsource the design or production. This includes carrying out a comprehensive risk analysis of the product, to identify potential hazards and implement the necessary measures to mitigate them.

As we have already seen in other articles on the blog, European regulations for the most part, as well as the new General Regulations (article here), determine the manufacturer as the operator that markets, designs or orders a product to be designed under its own brand or trade name.

Regulatory compliance should not be underestimated when marketing a product. It's not strange at all and in fact we can check it on the EU's Safety Gate portal (https://ec.europa.eu/safety-gate-alerts/screen/webReport), as dozens of products are recalled daily for some type of non-compliance.

Understanding Conformity Assessment

Conformity assessment is a verification process that demonstrates that a product complies with applicable legislation, before it can be placed on the market. It is carried out before the product is introduced to the market and continues to be carried out during its commercialization, covering both the design and production phases.

This proactive approach ensures that potential safety issues are identified and addressed from the initial concept to the final manufactured product.

It will be the regulations themselves, based on the risks associated with the product, that indicate the way to proceed and the path to follow to declare the conformity of our product:

Internal Production Control

It gives manufacturers the experience and quality management systems to self-evaluate their products based on relevant EU requirements. This method is typically suitable for lower risk product categories.

Relevant aspects of internal production control:

• Establishment of a Quality Management System: Manufacturers create a documented system that describes processes for design control, production control, final product inspection, and testing. This system ensures consistent quality and compliance with relevant standards throughout the product lifecycle.
• Conducting Conformity Assessments: Manufacturers carry out evaluations based on harmonized standards, voluntary technical specifications that are presumed to meet essential requirements, or other technical specifications. These evaluations can be carried out, for example, by carrying out laboratory tests.
• Compilation of a Technical File: The manufacturer collects all relevant information throughout the process in a technical file. This file typically includes details about the product design, the production process, and the conformity assessment activities carried out. We have a full article on the technical file here.
• Issuance of a Declaration of Conformity: Finally, the manufacturer issues a declaration of conformity, in which it assumes all responsibility for the product's compliance with all applicable EU requirements.

Participation of a Notified Body

For higher-risk products or when the complexity of the assessment requires outside expertise, regulations may require that a notified body be involved. These are independent organizations appointed by EU member states to assess compliance.

If the product in question is one of those that must be evaluated with the intervention of a notified body, the manufacturer must go to one of them, which are publicly listed on the NANDO website (https://webgate.ec.europa.eu/single-market-compliance-space/#/home).

It will be the regulations themselves that detail in detail to what extent this body must intervene, which, once its evaluation has been carried out, will issue a certificate of conformity that will help the manufacturer to make the declaration of conformity with reference to the certificate of the notified body.

This control to carry out certification by the notified body may only be limited to certain aspects of the product or to some of its functionalities. It is necessary to carry out a detailed study of the applicable regulations, to know in detail what will be the intervention of these entities.

Conformity assessment is a fundamental process for demonstrating that a product complies with applicable legislation before it is marketed. Manufacturers are responsible for carrying out a comprehensive analysis of the risks associated with the product, identifying potential hazards and taking the necessary measures to mitigate them. In addition, they must compile a technical file that documents the design, production, tests performed and risk assessment. This file must be available to market surveillance authorities and kept for a specific period, usually ten years after the product is marketed.

At Together Comply, we have accompanied more than a hundred companies and entrepreneurs, in this process of evaluating the conformity of their products, carrying out everything from technical documentation and regulatory studies, to advice on choosing the right notified body or laboratories.

European regulations are overwhelming and we are here to make it understandable, because good advice guarantees a good result. If you have any questions about your product's regulatory compliance, please contact us and we'll be happy to help.