CE Marking - Machinery (MD)
CE Marking for Machinery and Industrial Machinery (MD)
European Directive MD 2006/42/EC
Machinery Directive 2006/42/EC harmonizes the safety and health requirements for the design and manufacture of machines at European level and for the entire European Economic Area (EEA). These products must meet all the requirements established by law before being introduced to the market or used.
The aim of this directive is to have safer machines that contribute significantly to reduce accidents and damage to health, in the workplace or the domestic environment. By fixing the CE Marking on these products, the manufacturer or importer guarantees that they meet the requirements established by law in the European Union for safety, health and the environment.

Brief
1. This Directive applies to the following products:
(a) machinery;
(b) interchangeable equipment;
(c) safety components;
(d) lifting accessories;
(e) chains, ropes and webbing;
(f) removable mechanical transmission devices;
(g) partly completed machinery.
[…]
For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1(1)(a) to (f).
The following definitions shall apply:
(a) ‘machinery’ means: — an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,
— an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,
— an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,
— assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
— an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;
(b) ‘interchangeable equipment’ means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool;
(c) ‘safety component’ means a component:
— which serves to fullfil a safety function,
— which is independently placed on the market,
— the failure and/or malfunction of which endangers the safety of persons, and
— which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function. An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8(1)(a);
(d) ‘lifting accessory’ means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories;
(e) ‘chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;
(f) ‘removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product;
(g) ‘partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies;
[…]
Placing on the market and putting into service
1. Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall:
(a) ensure that it satisfies the relevant essential health and safety requirements set out in Annex I;
(b) ensure that the technical file referred to in Annex VII, part A is available;
(c) provide, in particular, the necessary information, such as instructions;
(d) carry out the appropriate procedures for assessing conformity in accordance with Article 12;
(e) draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery;
(f) affix the CE marking in accordance with Article 16.
[…]
- Modifications -
- Regulation (EC) N° 596/2009 - Adaptation to the regulatory procedure with scrutiny
- Directive 2009/127/EC - Amending Directive 2006/42/EC with regard to machinery for pesticide application
- Regulation (EU) N° 167/2013 - On the approval and market surveillance of agricultural and forestry vehicles
- Directive 2014/33/EU - Relating to lifts and safety components for lifts
¿Need assessment to perform the CE Marking to Machinery Products?
Sherpa Product Certification provides complete certification or concrete assistance at any stage and throughout the process of certification or CE Marking of Machinery and products covered by the European Directive 2006/42/EC, Our intervention will summarize and delimit the legal framework that applies to your products, facilitating the identification and understanding of requirements and the development of processes to fulfill them.
How Sherpa Product Certification can help?
- Classify the product and determine the legal framework applicable in each case.
- Identify essential requirements in specific Directives by product.
- Identify, acquire, adapt to the design and carry out tests on products according to Harmonized European and Regulatory Standards.
- Check and manage the intervention of an Accredited Body (Notified Body).
- Evaluate the Product’s Conformity Evaluation according to the mandate established in the Directive.
- Prepare and maintain the technical documentation.
- Write the Declaration of Conformity and carry out the CE Marking.

How can we Help you?
- Complete European Certification and CE Marking for your products
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- General inquiries about CE Marking
- Product analysis & classification in accordance with its applicable normative scheme and region
- Determine which regulations and directives apply to a product at an specific region
- Customs Tariff analysis for products and materials.
- Perform product conformity test according EN, ISO, IEC among others
- Product Market Access complete assistance
- Determine corrections and authenticity about specific Product Certifications.
- Determine manufacturer's, importer's and distributores responsabilities regarding product legislation.
- European Authorised Representative Services
- Write and validate product's Tecnical Documentation and Declaration of Conformity
- Perform Risk Analysis
- Packaging and labeling verification according to its applicable normative
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