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- LVD – Low Voltage Directive LVD2014/35/EU
- MCD | Directive Machinery_2006/42/CE
- DLS – Directive Lifts and Safety Components for Lifts_2014/33/UE
- EMC | Directive 2014/30/UE Electromagnetic Compatibility
- RED | Directive 2014/53/UE Radio Equipment Directive
- NOISE | Directive 2000/14/CE Noise
- PED – Directive 2014/68/UE
- ATEX – Directive 2014/34/UE
- Toys – Directive 2009/48/CE
- PPE – Regulation (EU) 2016/425
- GAR – EU Regulation 2016/426
- PED – Directive 2014/68/UE
- CE Mark Certification
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The certification process for compliance with the Machinery Directive 2006/42/EC involves assessing the safety of machinery, documenting compliance with essential health and safety requirements, and affixing the CE marking to indicate conformity with EU regulations. Compliance with the Machinery Directive is essential for manufacturers seeking to market machinery in the European Union.
The Machinery Directive 2006/42/EC is a European Union directive that establishes essential health and safety requirements for machinery and safety components placed on the market or put into service within the European Economic Area (EEA). The directive aims to ensure a high level of protection for workers and consumers by minimizing risks associated with the use of machinery.
Here's an overview of the certification process for compliance with the Machinery Directive 2006/42/EC:
Scope Determination
The first step is to determine whether the machinery falls within the scope of the Machinery Directive. The directive applies to a wide range of machinery, including industrial machinery, agricultural machinery, construction machinery, assembly lines, and more.
Risk Assessment
Manufacturers must conduct a risk assessment to identify and evaluate potential hazards associated with the machinery throughout its lifecycle, including design, manufacturing, installation, operation, and maintenance. The risk assessment should consider both foreseeable and non-foreseeable hazards and their potential consequences.
Design and Manufacturing Compliance
Manufacturers are responsible for designing and manufacturing machinery in accordance with the essential health and safety requirements set out in Annex I of the Machinery Directive. These requirements address factors such as machinery design, construction, ergonomics, noise emissions, energy efficiency, and more.
Technical Documentation
Manufacturers are required to compile technical documentation demonstrating compliance with the Machinery Directive. This documentation should include information about the design, construction, and testing of the machinery, as well as risk assessments, instructions for use, and information about any safety components or protective devices.
Conformity Assessment
The Machinery Directive allows manufacturers to choose from several conformity assessment procedures to demonstrate compliance with the directive. These procedures may include self-assessment based on internal production control, involvement of a notified body for assessment of full quality assurance, or type examination of individual products.
CE Marking
Once compliance with the Machinery Directive has been demonstrated, the manufacturer must affix the CE marking to the machinery. The CE marking indicates that the machinery meets the essential requirements of all applicable EU directives, including the Machinery Directive.
Declaration of Conformity
Manufacturers or their authorized representatives must draw up a Declaration of Conformity stating that the machinery complies with the requirements of the Machinery Directive. The Declaration of Conformity should be kept on file and made available to authorities upon request.
Market Surveillance
Competent authorities in EU member states are responsible for market surveillance activities to ensure that machinery placed on the market complies with the requirements of the Machinery Directive. This may include inspections, testing, and enforcement actions to address non-compliant products.
PRNS would serve CE mark certification services of Medical Devices, IVDs and other directive and regulations through Collaboration/Partnership Agreement with a European Notified Body.
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