Machinery Directive 2006/42/EC
The aim of the Machinery Directive is to improve safety when using machines, removing technical obstacles to trade and creating similar regulations within the European Economic area (EEA). The original 98/37/EC directive came into force on 1st January 1995 and applied to machines manufactured after this date.
In order for a machine to be CE marked, it is necessary for the machine to meet the basic requirements for health and safety. Documentation that includes an assurance of conformity and a documented risk analysis is also required. Most machines are usually also affected by other directives that must be complied with, usually the Low Voltage, and EMC Directive. CE marking only applies to safety and may not be used as an expression of quality or reliability.
Since 29 December 2009 2006/42/EC became applicable, superseding the Machinery Directive 98/37/EC. While the two are broadly similar, there are significant differences that affect machine builders, those performing final assembly and CE marking of machinery, and those placing imported machinery into the market in the EEA, Switzerland and Turkey.
The new Machinery Directive 2006/42/EC regulates the placing on the market, and the putting into service, of machinery in the EEA. This recasting of the Machinery Directive, which is a comprehensive amendment, is intended to extend the scope, improve clarity, remove some of the acknowledged flaws that existed in the old Directive, provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery, especially prototype and bespoke machinery, and introduce provisions for market surveillance.
Main requirements of the Directive:
• Safety of any powered equipment with moving parts
• Power can be electrical, pneumatic, hydraulic or other;
• Requirements for guarding, safety factors for loading, reliability of safety systems, marking and instructions;
• Extensive requirements for marking and instructions
Definition of Machinery:
• An assembly of linked parts or components at least one of which moves, with appropriate actuator, control and power circuits etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material.
• Interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or series of machines, or with a tractor by the operator himself in so far as this equipment is not a spare part or tool.
There are some exclusions listed in the Directive:
• Medical machines in contact with patients
• Passenger lifts and mine winders
• Boilers and pressure vessels
• Means of transport
• Military equipment
Please refer to the machinery directive for detailed requirements
Services that we offer as a notified body
CEM can offer services to approve all products defined in Annex IV of the directive and can help our clients, including manufacturers, importers and exporters, with conformity assessment services, which are necessary for CE marking the products . These services include:
Type Examination and /or Full Quality Control:
CEM can provide full EC Type Examination of machinery and issue a certificate confirming that it meets the requirements of the Machinery Directive. This is a requirement if a machine is listed in Annex IV and is not manufactured in accordance with relevant harmonised standards. It is also available for other machinery where third party certification is desiredAn assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole.
Technical File Lodging:
Where harmonised standards are applied in full, the Technical File must be lodged with a Notified Body. CEM will acknowledge receipt and provide secure storage for 10 years after the date of last manufacture.
Upon successful assessment, Directive 2006/42/EC on Machinery requires a technical documentation as laid out in Annex II. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.
The technical file should comprise:
• a detailed documentation on the construction of the machinery including drawings of the machinery and its parts,
• test results,
• description of protective measures
• other elements as described in Annex VII, A(a).
Also, the file must contain a copy of the EC declaration of conformity.
The manufacturer must also provide documents for series production and internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive (Annex VII, A (b)).
The manufacturer must carry out the necessary tests on components, fittings or the completed machinery to determine whether it can be assembled and put into service safely. The relevant reports and results shall be included in the technical file.
The manufacturer or his authorised representative is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed into the market.
How we can help
CEM International are a notified body for the Machinery Directive and can provide assistance with certification.