07/11/2022
New Machinery Regulation
DEEPENING
The final version of the Machinery Regulation which will replace the Machinery Directive 2006/42/EC contains numerous and significant changes with respect to the text in force today which we will deal with in this article.
A first change concerns the content and its index:
The final version of the Machinery Regulation which will replace the Machinery Directive 2006/42/EC contains numerous and significant changes with respect to the text in force today which we will deal with in this article.
A first change concerns the content and its index:
| MACHINERY DIRECTIVE 2006/42/EC | NEW MACHINERY REGULATION |
|
|
As can be read in the body of the text, the scope of application of the new machinery regulation object of the proposal remains the same, however there have been some clarifications deemed necessary aimed at putting an end to the discussions that have been going on for years regarding the definition of partly completed machinery; there is a new dash in the definition of machine which includes a whole which only lacks the loading of software intended for its specific application to avoid that manufacturers classify it as partly completed machinery. In addition, the definition of a safety component has also been clarified to include non-physical components such as software.
As regards the definition of "partly completed machinery":
As regards the definition of "partly completed machinery":
| MACHINERY DIRECTIVE 2006/42/EC | NEW MACHINERY REGULATION |
| g) «partly completed machinery»: assemblies which almost constitute a machine, but which, by themselves, are unable to guarantee a well-defined application. A drive system is a partly completed machine. The partly completed machinery is only intended to be incorporated or assembled with other machines or with other partly completed machinery or appliances to form a machine governed by this directive; | «partly completed machinery»: an assembly which is not yet a machine as it cannot function on its own to perform a specific application and which is intended solely to be incorporated into or assembled with a machine or other completed machinery or equipment, thus forming a machine. |
Another much-discussed issue concerned the classification of a modification as a substantial modification or not. Since there was no definition in the Machinery Directive, the Member States had adopted their own interpretation of it. However, the question has always been very delicate and subject of different interpretations. As solution, the machinery regulation provides, for the first time, the definition of "substantial modification":
"means a modification of a machinery or related product, by physical or digital means after that machinery or related product has been placed on the market or put into service, which is not foreseen nor planned by the manufacturer and affects its safety by creating a new hazard or by increasing an existing risk which requires:
(i) additional guards or protective devices, whose processing modifies the existing safety control system , or
(ii) additional protective measures to ensure the stability or mechanical strength of the machinery or related product;”.
Another very relevant change concerns the definition of "manufacturer" which is revised and extended:
"means a modification of a machinery or related product, by physical or digital means after that machinery or related product has been placed on the market or put into service, which is not foreseen nor planned by the manufacturer and affects its safety by creating a new hazard or by increasing an existing risk which requires:
(i) additional guards or protective devices, whose processing modifies the existing safety control system , or
(ii) additional protective measures to ensure the stability or mechanical strength of the machinery or related product;”.
Another very relevant change concerns the definition of "manufacturer" which is revised and extended:
| MACHINERY DIRECTIVE 2006/42/EC | NEW MACHINERY REGULATION |
| ‘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; | means any natural or legal person who manufactures a product subject to this regulation, or who has a product designed or manufactured subject to this regulation and markets this product under his own name or trademark, or manufactures a product subject to this regulation and puts it service for your own use. |
An important news concerns, however, the instructions of use of the machinery, as the obligation to provide them in paper format is no longer required, except in the case in which there is an explicit request from the buyer; the art. 10 of the Regulation, in fact, establishes the following:
Article 10 - Obligations of manufacturers of machines and related products
7. [...omississ…] When the instructions are supplied in digital format, the manufacturer must:
[...omissis…] (c) make them accessible online during the expected life cycle of the machine and for not less than 10 years after the machine has been placed on the market.
However, at the request of the user's purchaser at the time of purchase or up to 6 months after, the manufacturer provides the instructions in paper format free of charge.
Visit the ENGAL Services NewsRoom where you will find news regarding the Certification procedures, the Regulatory Updates, the news on the Interpretative Trends of the technical requirements and the Problems encountered in the matter of Conformity and Certification.
Article 10 - Obligations of manufacturers of machines and related products
7. [...omississ…] When the instructions are supplied in digital format, the manufacturer must:
[...omissis…] (c) make them accessible online during the expected life cycle of the machine and for not less than 10 years after the machine has been placed on the market.
However, at the request of the user's purchaser at the time of purchase or up to 6 months after, the manufacturer provides the instructions in paper format free of charge.
Visit the ENGAL Services NewsRoom where you will find news regarding the Certification procedures, the Regulatory Updates, the news on the Interpretative Trends of the technical requirements and the Problems encountered in the matter of Conformity and Certification.
Please complete the form to send us a message
Fields marked with an asterisk (*) are mandatory.