A machine is defined, in the strict sense (Art.2), as 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.
Products missing only the electric motor, requiring mounting or to be assembled with others are all regarded as machinery in the strict sense.
In addition to machinery in the strict sense, the MD brings into scope several other products (Art.1):
- ‘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;
- ‘safety component’ means a component:
- which serves to fulfil 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 for the function of the machinery , or for the specific function it may be substituted by normal components;
- ‘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;
- ‘chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;
- ‘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 considered as one product;
- ‘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 that is in the scope of the Directive after incorporation;
There are some machinery excluded from the Directive – for example motor vehicles used on public roads military equipment, machines which are already covered by other, more specific, directives.
Some equipment falls within the scope of Low Voltage Directive (for example ‘ordinary office machinery’ and household appliance for domestic use) on the grounds that the risks they present are mainly electrical in nature.
It also possible that only health and essential requirements of the MD are applicable to medical devices, lifts, which are out of the scope of the MD, to the extent that the requirements of the MD are relevant and more specific than the one included in the Medical Devices directives.
Secondhand machinery is excluded from the scope of the Directive unless that machinery is refurbished or upgraded so that its original specification is changed.
Equipment manufactured for the manufacturer’s own use is not excluded from the requirements but may be subject to slightly lesser obligations with respect to marking and documentation.