CE marking: basic concepts
Speakers
Eng. Claudio Delaini
[00:00] Introduction
This webinar will address the CE marking of products, the conditions for its applicability, current legislation, and how to apply the marking.
There are three key points:
1. Not all products require the CE marking; there are categories that distinguish them;
2. All products, to be sold and used within the EU, must be safe;
3. The CE marking is only valid within the EU. Internationally, the CE marking is recognized as a safe and reliable mark.
[01:40] Regulatory Standards
The first regulatory reference is Regulation 765 of 2008, which formalizes the decision by European states to unify national directives so that they all refer to a single regulation when it comes to marketing products within the EU. The goal is to build a single market that promotes safe products.
The regulation contains definitions, adopted uniformly by all countries. In particular, four roles emerge:
Manufacturer
Importer
Authorized Representative
Distributor
These four roles have different responsibilities, but all manage a phase of the product and are responsible for its safety for those who use it.
Article 30 discusses the CE marking, and specifically states that it may be affixed only by the manufacturer and his authorized representative. By affixing it, the manufacturer/authorized representative assumes all the responsibilities required for the product to be safe.
The second regulatory reference is Decision 768 of 2008. The decision outlines the obligations of the main players in product trade. Annex I, Section R2, discusses the obligations of economic operators.
Article R2 discusses the obligations of manufacturers. One of the manufacturer's main obligations is to perform a product risk assessment, draft a risk assessment document, and a user and maintenance manual to ensure safe use of the product. Only after this can the CE marking be affixed, which has its own rules for drafting and affixing. The documentation, along with the batch/serial number, allows for product traceability.
Article R4 discusses the obligations of importers. Their primary responsibility is to place only compliant products on the EU market. Furthermore, they must conduct checks, such as random testing, etc.
Article R5 discusses the obligations of distributors. When distributors make a product available on the market, they must conduct a formal product inspection, but they do not have the same responsibilities as a manufacturer or importer; they must proceed "with due care." If there is obvious non-compliance, the distributor can withdraw the product from the market.
[7:25 PM] Which directives should I choose?
Regulation 765/08 and Decision 768/08 are reference texts, on which other directives and regulations rely. To determine which specific directive to refer to, we use a "pyramid" approach, moving from product-specific directives (e.g., the Lift Directive) to general product directives (e.g., the Machinery Directive).
There is some help: search for harmonized directives, which are mapped online (https://ec.europa.eu/growth/single-ma...) and cover a myriad of different products. The choice is based on the product's "intended use."
CAUTION: Choosing a directive does not mean it will be the only one applicable. You must select all the directives that fall under the scope of the product in question. Here too, you use a "pyramid" approach, choosing the most general directives and moving toward increasingly more specific directives.
[38:00] Technical File and Declaration of Conformity
To summarize the key steps, once a product has been identified, you should ask yourself:
What role does it play in the trade (manufacturer, distributor, etc.);
Which harmonized directives should be considered for the product in question (e.g., ATEX if it operates in explosive environments);
What documentation should be produced?
Then, the Technical File is prepared. The technical file explains the product and its functions, performs a risk assessment, satisfies the essential safety requirements, and includes instructions and a copy of the EC Declaration of Conformity. The technical file must be created and is covered by trade secrecy.
Then, the EC Declaration of Conformity is prepared. It must include the manufacturer's company name and full address. It must include a description of the machine, with all the information necessary to link the machine to the technical file. Finally, the technical standards applied to prepare the declaration of conformity are indicated.
For more information, read here: https://www.certificazionece.it
#machinerysafety #safemachinery #claudiodelaini #cecertification #worksafety