The European Machinery Directive 2006/42/EC (MD) constitutes the regulatory basis for the harmonization of essential safety requirements for machinery at European level. The directive guarantees the free movement of machinery within the single market, as well as a correct level of protection for workers and citizens of the Union.
This directive falls within the legislative framework for the free movement and marketing of products in the European community.
Generally, the directive aims to avoid risks associated with a product or phenomenon. The same product can be regulated by various directives.
The purpose of this directive is to defend a common interest of European citizens and European companies.
The English name for this directive is: Machinery Directive;
Its abbreviated acronym is: MD;
Its code is: 2006/42/EC;
The previous directive on this topic, which is no longer in force today, is: 98/37/EC.
It is useful to know the references of the old directives because they are often found in the documentation of products or components, but also in European laws and regulations if they have not been recently updated.
Field of application: this directive concerns the product-machine defined as "the assembly equipped or intended to be equipped with a drive system other than direct human or animal power, composed of parts or components, of which at least one is mobile, solidly connected to each other for a specific application”;
Essential requirements: these products, to be placed on the European market, must comply with the following essential requirements. These requirements are determined through a risk assessment of the product, to identify which specific aspects need to be explored in depth and according to which standards this investigation must be carried out.
Main contents of the directive
- Field of application
- Essential requirements
- Manufacturer's obligations
- Obligations of other economic operators
- Free movement
- Presumption of conformity and harmonized standards
- Conformity assessment
- Notified bodies
- CE marking
These are the reasons that led to the writing of the directive.
Field of application
The scope defines the categories of products or phenomena regulated by the directive.
Often a general criterion is given accompanied by explicit lists of products/phenomena that are subject to the directive and of products/phenomena that are excluded from the directive in order to clarify particular situations.
They also serve to understand the scope of the directive by providing definitions of the main terms used.
The essential requirements are requirements that the product must comply with in order to be placed on the market.
The requirements are often found in Annex I of the Directive.
The manufacturer (or his authorized representative in the European Community) is primarily responsible for placing a product on the market. This chapter describes the obligations and procedures that it must follow, referring to the annexes of the directive for more detailed aspects.
Obligations of other economic operators
Distributors and retailers are also responsible and liable if they trade in items that do not comply with European directives. They must check that the manufacturer has had the electrical safety test carried out, that the product has the EU declaration of conformity and that it bears the CE mark.
The potential importer must ensure that the procedures for verifying the conformity of the product have been carried out, must verify the presence of the CE marking and ensure that the technical documentation of the product is available to the competent national authorities.
Member States must presume that products bearing the CE marking comply with all provisions of the applicable directives requiring its affixing. They cannot therefore prohibit, limit or prevent the placing on the market and putting into service on their territory of products bearing the CE marking, unless the provisions relating to CE marking have been applied improperly.
Presumption of conformity and harmonized standards
The directives of our interest are associated with a list of harmonized standards which is published in the European Official Journal.
Harmonized standards make it much easier to verify the conformity of a product with the requirements of a directive. These standards describe in detail how the tests or other assessments necessary to assume that a product is compliant must be carried out.
If harmonized standards covering all the requirements of the directive are available for a product, if these standards are applied fully and the product passes all the tests foreseen in these standards, then it can be assumed that the product complies with the requirements of that directive.
In the absence of harmonized standards suitable for the product, the path is more complicated and expensive.
Equipping a suitable laboratory to carry out the tests required by the Harmonized Standards is quite expensive. For this reason, manufacturers often rely on external testing laboratories.
In Europe it is the body that can carry out a conformity assessment by acting as a third party or evaluate whether the one carried out by the manufacturer and its trusted laboratories is correct.
In most cases, however, the use of a notified body is not foreseen or in any case not necessary.
Products that comply with all provisions of the applicable directives requiring the CE marking must bear it. This marking is, in particular, an indication that the products comply with the essential requirements of all applicable directives and that they have undergone a conformity assessment procedure provided for by the directives themselves. Member States are also required to take the necessary measures to protect the CE marking.
Sicom Testing offers a complete service for CE certification of the products.
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