As already anticipated in the previous newsletter, the new European standardisation regarding Machinery will be published as a Regulation in the near future.
This is an important step, as a Regulation is a binding legal act and it must be implemented in its entirety in the whole European Union.
Instead, the Directive is a legal act aimed to set a goal that must be achieved by all Countries in the EU; however, it is up to any and each Member Country of the EU to define how such goals shall be achieved, through national regulations.
Indeed, the necessity for Manufacturers to acknowledge the Directive's transpositions in the Country of destination of a product (in our case, a Machinery) is dropped; such circumstances would also be difficult to intepret, also because of language barriers among European Union Countries.
Another distinguishing feature of the new Rules of Procedures' proposal is its alignment to the New Legislative Framework (NLF), which clearly identifies all the traders involved in product placement and their obligations towards the final user.
The Declaration of Conformity has been edited as well, now aligning with the new EU standards, by now transversal to all the new Directives and Rules of Procedures published so far.
More specifically, the new proposal for Rules of Procedures has been improved in some of its steps, such as the list of machineries and products excluded from its scope. Here, though, we would rather dwell on the annexes.
Annex I changes face, becoming indeed what is the actual Annex IV. In this Annex, the proposal reports an update for high risk machineries, adding machineries which use Artificial Intelligence (AI) and Softwares that ensure safety features. As a matter of fact, for the machineries included in such Annex, the Notified Body's intervention becomes mandatory.
Annex II of the Rules of Procedures' proposal reports the list of Safety Components; digital components have been included, such as the software which ensures safety features (including AI systems). Such software, at the stage of product placement, will need to provide CE mark, including UE declaration and instructions for use.
The current Annex I of the Machinery Directive becomes Annex III in the Rules of Procedures' proposal.
The well known EHSr (Essential Health and Safety requirements) have been updated, taking into account the new enabling technologies featuring I4.0 (Industry 4.0).
Requirement 1.1.9 (Protection Against Corruption) is completely new. Such requirement states that the software of a system which is intertwined with another device shall be able to gather data from legitimate or illegitimate interventions, which could somehow lower the machinery's (or product's) safety level, where the software is installed.
Another new aspect, regarding a well-known topic, covers the requirement 1.7.4 (Instruction), where the possibility to provide digital Instructions for Use and Declaration of Conformity has been introduced, even “On-Line” through login credentials.
In our opinion, this is a very important step towards a machinery's greater environmental sustainability.
On this specific point, Faentia Consulting has already been offering Digital Products for the digital use of technical documentation, both On-Line and Off-Line (see https://www.faentia-consulting.com/en/news/40-instructions-use?q=it/news/istruzioni-luso-40 ).
It will always be possible to receive the hard copy, but only if explicitly required by the user.
We are at the beginning of a new and important step in machinery designing and marketing, within the European Union market.
As opposed from previous updates, which had seen the Machinery Directive step from 89/392/CEE to 98/37/CE to the longest-running 2006/42/CE, this step also embraces the new Era of the Fourth Industrial Revolution, more or less intentionally, which in the near future will bring an unprecedent and unimaginable evolution.
Faentia Consulting aims to provide their clients with further details regarding what the impact of the Machinery's Rules of Procedures will be, offering information about timing of implementation and maintenance of the existing certifications, in the shift from the old directive to the new legal act.
FAENTIA CONSULTING SRL
Ing. Claudio Barone
Product Safety Eng. B.U.
For this reason, we invite you to follow us on our website or Linkedin profile and to contact us in case you have questions regarding the new Machinery's Rules of Procedures.