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F2 Labs would like to inform you of several recast EU technical Directives

The European Union recast several technical Directives over the past two years. Many of these Directives will replace current EU legislation in 2016. The purpose for this is to align the Directives with the New Legislative Framework (NLF) adopted in 2008.

We have summarized the dates and some of these changes for you below.

Most notably, the EU Declarations of Conformity required by all of the recast Directives are required to be translated. Additionally, these new Directives require that you provide translated instructions with all equipment. F2 Labs can assist you in obtaining these translations.

Here are some additional changes:

The Low Voltage Directive 2014/35/EU will replace the Low Voltage Directive 2006/95/EC

• Date: April 20, 2016

• Scope: changed

• Technical requirements: unchanged

• Documentation requirements: changed.

The new LVD requires among other things, a differently formatted EU declaration of conformity and a contractual understanding between the manufacturer and importer regarding the handling of the Technical File.

The EMC Directive 2014/30/EU will replace the EMC Directive 2004/108/EC

• Date: April 20, 2016

• Scope: changed

• Technical requirements: unchanged

• Documentation requirements: changed.

In particular, the Technical documentation (TF) requirements have increased in the amount and complexity of necessary information. Notably, the technical documentation makes a requirement for a risk assessment which will affect the compliance process if the product is not within the scope of the Low Voltage Directive or the Machinery Directive.

The Radio Equipment Directive 2014/53/EU will replace the R&TTE Directive 1999/5/EC

• Date: June 13, 2016 (R&TTE equipment may be supplied until June 12, 2017)

• Scope: changed

• Technical requirements: unchanged

• Documentation requirements: changed.

The new RED changes the Technical documentation (TF) requirements by increasing the amount and complexity of necessary information, including a statement by the manufacturer regarding the impact of the equipment on the radio spectrum in the locale of the end-user.

The ATEX Directive 2014/34/EU will replace the ATEX Directive 94/9/EC

• Date: April 20, 2016

• Scope: changed

• Technical requirements: unchanged

• Documentation requirements: changed.

The new ATEX Directive will require new ATEX certificates necessitated by the change in wording in the new Directive. We can help you make this transition.

Please note that the Machinery Directive 2006/42/EC and the Medical Devices Directive 93/42/EEC have not changed.

F2 Labs has studied the new, updated European Directives since their release in early 2014. While the changes may not require additional testing (by the Directives), there are differences in the compliance process. We are here to help you and can answer questions about your specific project.

Please feel free to contact us if you have any questions regarding these updates.
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