Frequently asked questions about CE Markingby Arianna Lane marketing head
1. Who is considered a manufacturer in the Directives?
As a general rule, it will be the one that assumes responsibility for the design and manufacture of a product. It also includes who changes the application or characteristics of a product and who assembles a set based on elements and unfinished products, but each Directive can have its particularities.
2. What responsibility do the manufacturers of non-complete components or products have?
It is not possible to give a general response since it will depend on the product and the Application Directives. Some Directives only deal with products, "Simple pressure vessels", while others, such as the Construction Products Directive or Low Voltage Directive, cover unfinished products.
In addition, the Machinery Directive establishes several procedures depending on whether it is a machine, a safety component or a non-complete machine or which is to be incorporated into another machine.
In the case of the replacement of a worn or defective part by an identical part, a simple repair operation that does not modify the characteristics of the equipment at all, this change is not considered to alter the situation of the product with respect to its compliance with the applicable Directives.
But when this change entails a significant complex set modification for some requirement of the Directive, the person responsible for the modification will assume responsibility for complying with the applicable directives.
By means of the CE Marking, the manufacturer of a device indicates that it complies with the essential requirements set out in the Community Directives that apply to it. Therefore, if the products are non-compliant, they cannot be marketed.
The Administration, for control purposes, establishes annual inspection plans (Industry, Consumption,) that result in the establishment of fines, and the withdrawal of the market or prohibition of the putting into circulation of equipment that endangers the safety or health of people, goods or the environment, both in the USA and in the rest of the EU Representative member countries.
To consult the objective scope of responsibilities, we can resort to Law 22/94, of July 6, which regulates civil liability for damages caused by defective products, and adapts the provisions of Directive 1999/34 to our legal system/EC of 10 May, whose purpose is to achieve a homogeneous legal regime within the EU of the aforementioned responsibility.
One of the objectives of the CE Directives is the elimination of obstacles to the free movement of products. In this way, each directive sets qualitative guidelines to guarantee the safety and health of users, goods and the environment. Well, all of the above we quantify through standards.
The obligatory thing is the fulfillment of the Directive applicable in each case, but we use the norms (voluntary).
However, the most comfortable way to ensure that we meet the essential requirements set forth in the Directives is to use what is called the Harmonized Standard, as it grants a presumption of conformity with those essential requirements.
The manufacturer is free to use other means to meet the essential requirements but must reach a level of safety at least equivalent to that established by harmonized standards.
If these standards are not used, and depending on the directive in question, a Type Exam by a Notified Body may be essential.
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Created on Dec 6th 2019 12:07. Viewed 406 times.