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Which are the current CE marking Directives and Regulations?

24.07.2021

Affixing the CE Marking to your product is one of the most challenging yet significant processes, before successfully launching your product and placing it on the European market. As an economic operator (a manufacturer, an authorised representative, an importer, or a distributor) you are confronted with numerous questions regarding the CE Marking Directives and Regulations. Seize the opportunity and gain an in-depth overview of the scopes of the applicable EU Directives and Regulations and contact us with any request.

Is it necessary to stay informed on the CE marking Directives and Regulations?

The question above requires an indisputable ‘yes’! When it comes to the EU Market, the economic operators have to comply with the legal requirements as set out in the applicable EU Directives and/or Regulations.

By definition, “regulations” stand for mandatory, binding, legislatives acts that apply fully across the EU. The legislative act is the common ground shared by “regulations” and “directives”, however, with differences evident in several aspects. “Directives”, in particular, are legislative acts aimed at a certain goal that all EU countries must accomplish. However, what is essential to the “directives” is that each country is allowed to draft its own laws in order to achieve that specific goal.

IN WHICH COUNTRIES IS IT REQUIRED TO AFFIX A CE MARKING?

A CE marking is legally required in all countries covered by the European Economic Area (EEA). Check the following list of the EEA countries. READ MORE

Both CE marking Directives and Regulations include essential health and safety requirements that should be followed by the economic operators. This is the principal reason why manufacturers, authorised representatives, importers, or distributors must stay informed on the latest developments regarding the Directives and Regulations, and follow the obligatory steps to affix CE marking. After all, the very first step of the CE Certification process is to find out which EU Directive(s) and/or the EU Regulation(s) apply to your product!

Current CE marking Directives and Regulations

In order to determine which EU Regulations or EU Directives cover your product, it is of fundamental importance to examine the following list of the current CE marking Directives and Regulations:

ATEX Directive 2014/34/EU (prior: 94/9/EC) ATEX Directive 2014/34/EU (prior: 94/9/EC)
Construction Products Regulation 305/2011/EU Construction Products Regulation 305/2011/EU
General Product Safety - Consumer Products 2011/95/EU General Product Safety - Consumer Products 2011/95/EU
CE marking is NOT required
The Low Voltage Directive 2014/35/EU (prior: 2006/95/EC) The Low Voltage Directive 2014/35/EU (prior: 2006/95/EC)
The EMC Directive 2014/30/EU (prior: 2004/108/EC) The EMC Directive 2014/30/EU (prior: 2004/108/EC)
The Machinery Directive 2006/42/EC The Machinery Directive 2006/42/EC
Medical Devices Reguation 2017/745 Medical Devices Reguation 2017/745
The Personal Protective Equipment Regulation 2016/425/EU (PPE) The Personal Protective Equipment Regulation 2016/425/EU (PPE)
The Pressure Equipment Directive 2014/68/EU (prior: 97/23/EC) The Pressure Equipment Directive 2014/68/EU (prior: 97/23/EC)
The Radio Equipment Directive 2014/53/EU (prior: 1999/9/EC) The Radio Equipment Directive 2014/53/EU (prior: 1999/9/EC)
The RoHS Directive 2011/65/EU The RoHS Directive 2011/65/EU
The Toys Safety Directive 2009/48/EC The Toys Safety Directive 2009/48/EC

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Regulations and Directives are an undeniable, vital part of the certification procedure. You just had an overview of “Which are the current CE marking Directives and Regulations”. Yet, this is only a quick glance as both EU Regulations and Directives are rich in details and parameters. Amendments may occur and the certification steps may differ from case to case. Our experts are here to efficiently guide you in the certification process, in order to obtain the best possible results on your behalf.

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