2006/42 / EC - Machinery and Mechanisms
The EU engineering sector, consisting of 1/3 of the world markets, is one of the largest and most competitive sectors with its 170,000 companies and more than 3.3 million Employees. Minimizing the risk of an accident caused by the use of equipment is one of the most important EU policies. The CE marking on the machine indicates that this piece of equipment complies with the requirements of occupational safety and health as established in 2006/42 / EC and may be sold at EEA. The Machinery Directive covers machinery, replacement equipment, safety components, lifting accessories, chains, cables and belts, removable mechanical transmission devices and partially equipped equipment.
If the product falls into one of 23 categories of risk, as defined in the Directive, and does not comply with a harmonized standard that covers all basic requirements for occupational health and safety, the authorized body must carry out conformity assessment activities. If the Authorized Body is convinced of the product's conformity, it issues a certificate, which we call the EU Type Examination Certificate or the Full Quality Guarantee Certificate, which confirms compliance.
Regardless of the role of the authorized body, the manufacturer must draw up the EU Declaration of Conformity and technical documentation, and these requirements are legally binding.
The technical file that must be prepared by the manufacturer must contain the following information and documents:
General definition of technology
Detailed documentation on the design of the machine, including drawings of the machine and its parts,
Calculations, experimental results and detailed drawings to confirm the equipment’s compliance with the basic requirements,
Electrical Safety - LVD Test Report,
Risk assessment of machines and the following documents:
The list of basic requirements for equipment
Explanation of preventive measures
The standards to be used and the documents of the basic requirements covered by these standards
Copy of equipment manual
EC declaration of conformity for components used in the manufacture of equipment, where necessary,
Copy of EC Declaration of Conformity
In addition to this, the manufacturer must carry out the necessary tests of components, fittings or finished equipment, and relevant reports should be included in the technical file. The manufacturer or its authorized representative is also requested to keep copies of the technical documentation.
WHAT INFORMATION SHOULD BE INCLUDED IN THE DECLARATION OF THE EU CONFORMITY FOR EQUIPMENT?
At the end of a successful evaluation, the technical documentation should be sufficient to demonstrate the compliance of the product with the essential requirements of the directive and contain the following:
Name and address of the manufacturer or its authorized representative,
Name and address of the person authorized to prepare the technical file
Definition of equipment, including code, function, model, type, serial number and trademark.
Declaration of conformity with the essential requirements of this Directive (2006/42 / EC) and / or other relevant directives
Where applicable, the name, address and identification number of the Authorized Body conducting the EU Type Examination, as specified in Annex IX, and the EU Type Examination Certificate Number
Where applicable, the name, address and identification number of the Authorized Body confirming the Full Quality Guarantee System, as specified in Appendix X
Where applicable, reference to harmonized standards, as specified in paragraph 2 of Article 9 of the Directive.
Where applicable, reference to other technical standards and specifications.
Place and date of announcement
Identification information and the signature of the person authorized by the manufacturer of the declaration by the manufacturer or his authorized representative.