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The EU EMC Directive 2004/108/EC is changed to 2014/30/EU

The new EU EMC directive 2014/30/EU was published on OJ (L96/79) on March 29, 2014, replacing the old EMC directive 2004/108/EC to meet the requirements of NLF (New Legislative Framework).

Effective time:

2014/30/EU will take effect on April 18, 2014. The old EMC Directive 2004/108/EC will be repealed on April 20, 2016.

Distributors must make reasonable transitional arrangements before this directive (2014/30/EU) completely replaces the old directive (2004/108/EC) to place the ordered products (that is, the inventory equipment that has been provided to the distribution chain) on market.

Product Range:

The products covered by the new directive include new products put on the EU market, as well as products supplied in different forms, including remote sales products. But it does not apply to special evaluation kits that can only be used solely for research and development facilities.

New directive requirements:

Clearly state the obligations and responsibilities of various operators, namely manufacturers, authorized representatives, distributors, importers and their respective representatives of related products, in the supply and sales chain.

The detailed regulations for the notification of Conformity Assessment Bodies have been formulated. It details all the requirements and obligations of the notified body. It also points out in detail all the requirements, obligations, applications, changes, operations, appeals and mutual coordination of the Notified Bodies.

In particular, for some basic requirements, manufacturers can choose to adopt internal production control methods (Annex II) to reduce the application for conformity assessment procedures. For other basic requirements, the type conformity assessment can be based on the internal production control method (Annex III) and the EU type inspection procedure.

New requirements have also been added to the technical documentation:

-Design concepts and manufacturing images, as well as component schemes, sub-components, principles, etc.;

-Necessary descriptions and instructions to understand those images and schemes and understand the operation of the equipment

The manufacturer shall affix the CE mark on each individual piece of equipment to meet the appropriate requirements of this directive. The manufacturer should also formulate a written EU compliance statement for the device model. When the device has been put on the market, the statement should be kept together with the technical documentation. Until 10 years later, it can be dealt with through national institutions.

The official form of non-compliance is also listed in the new directive. The new directive states that any member state should require relevant economic operators to correct non-conformities, or the relevant member state should take all appropriate measures to restrict or prohibit equipment already available on the market, or to ensure that its equipment is recalled or withdrawn from the market go.

Each member state should formulate relevant penalty rules, which are suitable for operators who violate national laws and regulations. Each member state shall take all necessary measures to ensure the enforcement of penalty rules. These penalties may include criminal penalties for serious violations.

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