Last edit: 11/08/2023
New definition of “partly completed machinery”
Hereafter the new language and the today’s one
[New M.P.R.] – Art. 3. Definitions
(10) ‘partly completed machinery’ means an assembly which is machinery but for the fact that it cannot in itself function so as to perform a specific application and which is only intended to be incorporated into or assembled with machinery or other partly completed machinery or equipment, thereby forming a machinery product;
[2006/42/EU] – Art. 2. Definitions
(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;
A machine that carries out a very specific application, inserted in a production line and which needs signals from the rest of the line in order to function, is in effect a partly completed machine “for the fact that, without those signals and consensus, it cannot in itself function so as to perform a specific application”.
That also means that a robot, even with its end effector, if it needs signals, for example, from a press, it is a PCM since, without those signals, it stands still.
The new definition of “Manufacturer”
That is not in today Machinery directive and countries have developed their own interpretation. Modifications to already installed machineries are a problem for the user, since no manufacturer wants to bear the responsibility of the parts he did not modify.
The definition of Manufacturer also changes. At the moment, according to a strict interpretation of the Definition, a manufacturer has to physically construct the machinery. With the new definition, a manufacturer can also have the machinery manufactured by somebody else. In other terms, anybody can be a manufacturer, what is important is that he has the knowledge and the ability of giving instruction how the safety has to be implemented. He must have full control on the safety aspects of the machinery, production line or process: he/she can then be a manufacturer and CE mark the product.
[New M.P.R.] – Art. 3. Definitions
(17) ‘manufacturer’ means any natural or legal person who manufactures machinery products or who has machinery products designed or manufactured, and markets those machinery products under his or her name or trademark or who designs and constructs machinery products for his or her own use;
[2006/42/EU] – Art. 2. Definitions
(i) ‘manufacturer’ means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer;
Instructions for use
There is not anymore the obligation to provide them in Paper format, unless the user asks for it.
[New M.P.R.] – 5.1. Implementation plans and monitoring, evaluation and reporting arrangements
Digital documentation: EHSRs 1.7.4 on instructions and Annex V on the manufacturer’s declaration of conformity allow that manufacturers provide digital instructions and the declaration of conformity. Nevertheless, a paper format is mandatory upon request.
Moreover, there is not anymore any obligation to provide them in the official language of the country of installation.
[New M.P.R.] – Annex III: EHSR
1.7. INFORMATION – 1.7.4. Instructions
The instructions accompanying the machinery product shall be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation shall be accompanied by the original instructions.
[…]
(a) The instructions shall be drafted in one or more official languages of the Union. The words ‘Original instructions’ shall appear on the language version(s) verified by the manufacturer or his or her authorised representative;
[2006/42/EU] – Annex I: EHSR
1.7. INFORMATION – 1.7.4. Instructions
All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.
The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.