CE-Marking
Any machinery or product covered by EU product directives or regulations must not be sold or placed on the market without bearing a CE-mark.
CE-mark is actually a manufacturers self-declaration about its product fulfils the requirements from directives and standard.
CE-marking is not a certification or an approval, but a mark that indicates compliance with certain essential health and safety requirements within the relevant product area.
There is 20+ EU Directives and Regulation that require CE-marking.
The CE marking process is carried out by the manufacturers through a 6-step procedure, declaring that the product complies with relevant EU legislation.
We assist manufacturers and end-users with CE marking according to the Machinery Directive, Low Voltage Directive (LVD), and ATEX directive.
Machinery directive
Machinery Directive 2006/42/EC is one of the CE-marking directives and applies to the following products:
Machinery
Interchangeble equipment (agricurtual equipment)
Safety components
Lifting accessories
Chains, ropes and webbing
Removable mechanical transmission decices,
Partly completed machinery
To fulfill the requirements from Machinery Directive and affix the CE-mark on your machine you need to go through the four steps of compliance:
Complying with Essential Health and Safety Requirements - EHSR
Compile the Technical file
Issue the Declaration of Conformity, and
Affix the CE-mark
Compliance with EHSR in practice requires conducting and documenting a risk assessment to ensure the inherent safe design of machine. To provide such a risk assessment document, manufacturers shall adhere to solutions and techniques from harmonized standards, beginning with ISO 12100 for risk assessment.
GS assists manufacturers and end-users throughout the entire CE-marking process, especially in conducting risk assessments using various tools and templates.
The Machinery Directive underwent a thorough revision and will be superseded by a new Machinery Regulation. This regulation was published in June 2023. With a transition period of three and a half years, the new Machinery Regulation will become applicable starting from January 2027.
ATEX Directive
Potential explosive atmosphere or more known as ATEX is divided into two different directives.
Manufacturers of equipment designed for use in explosive atmospheres must comply with ATEX Directive 2014/34/EU. Facility owners and employers are required to meet the obligations outlined in ATEX Directive 1999/92/EC, also referred to as the User Directive or ATEX Workplace Directive.
While the equipment manufacturer must complete all compliance steps to CE-mark the Ex-product and place it on market, employers are required to conduct and prepare an Extended Workplace Assessment (EWA), commonly known as ATEX EWA. This process typically involves:
Evaluation of risks of the formation of explosive atmosphere,
Preparation of the zone classification,
Potential ignition sources risk assessment..,
GS provide support in fulfilling both directives, regulatory compliance and achieving the inherent safe design prescribed by the standards.
Low Voltage Directive (LVD)
The LVD 2014/35/EU is a European Directive that establishes essential health and safety requirements for electrical equipment designed for use within certain voltage limits, between 50 to 1000 V for alternating current (VAC) and 75 to 1500 V for direct current (VDC).
Products that fall under the scope of the Low Voltage Directive (LVD) include various household appliances, mobile phone chargers, light chains, lamps, low-voltage control panels and assemblies, as well as audio and video electronic devices, among others.
GS provides guidance, support, and assistance to manufacturers and the entire supply chain to ensure regulatory compliance from third-parties or Notified Body and to obtain CE marking for products under the Low Voltage Directive (LVD).
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