Revision of the Machinery Directive

Draft for a new Machinery Regulation published

The EU Machinery Directive is currently being revised, on April 21st a draft regarding a possible new Regulation was published. Hereinafter you can find some facts and information regarding this publishment.

Link, formalities and dates:

• You can find a link to the draft of the new Machinery Regulation here
• The published documents concerned are “proposals”, hence suggestions that are neither already valid nor decided to be effectively implemented
• The recommendation is that no longer a Directive (like the current Machinery Directive 2006/42/EC) but a Regulation settles the machine-specific product safety in Europe
• The draft schedules that the new Regulation must be adopted within 30 months after its official announcement (the date refers to the date once the Regulation has been effectively adopted, not to the date of the draft, which can still undergo several modifications)
   

Suggested modifications with regard to contents (selection):

Adaption to the New Legislative Framework

• Some Directives have already been adjusted to the New Legislative Framework, e.g., the Low Voltage Directive or the Directive on Electromagnetic Compotability.
• The basis for the New Legislative Framework is Decision No. 768/2008/EC, which defines amongst other consistent denominations for economic actors (manufacturers, importers, etc.) as well as distinctive modules for conformity assessment procedures
• The current Machinery Directive 2006/42/EC is a Directive of the so-called New Approach, however has it not been adjusted to the New Legislative Framework yet. Corresponding to the suggestion for a modification of the Machinery Directive, this leads to substantial inefficiencies as divergent definitions between different Community harmonization legislations (Machinery and Low Voltage Directive) still coexist. For this reason, the proposal plans to eliminate these discrepancies

New Technologies
The proposal states that the current Machinery Directive does not allow for new technologies or even prevents their implementation, such as:

• Collaborative robots
• Connected Machinery
• Software Updates
• Self-learning machines (artificial intelligence)
• Autonomous machines

Cyber-Security

• The list of essential requirements should obtain an own item 1.1.9 regarding Cyber-Security with impact on safety functions. This section would be entirely new:
  
  1.1.9. Protection against corruption
  The machinery product shall be designed and constructed so that the connection to it of another device, via any feature of the connected device itself or via any remote device that communicates with the machinery product does not lead to a hazardous situation. A hardware component for connection that is critical for the compliance of the machinery product with the relevant health and safety requirements shall be designed so that it is adequately protected against accidental or intentional corruption. The machinery product shall collect evidence of a legitimate or illegitimate intervention in the hardware component. Software and data that are critical for the compliance of the machinery product with the relevant health and safety requirements shall be identified as such and shall be adequately protected against accidental or intentional corruption. The machinery product shall identify the software installed on it that is necessary for it to operate safely, and shall be able to provide that information at all times in an easily accessible form. The machinery product shall collect evidence of a legitimate or illegitimate intervention in the software or a modification of the software installed on the machinery product or its configuration.
   
• Furthermore, the draft plans an adjustment of item 1.2.1 (safety and reliability of control systems) from the essential requirements.

More precise scope: 

• Revision of the definitions “machine” and “partly completed machine”
• Clarifications in the differentiation to the Low Voltage Directive

Substantial modification:

• This very important topic for industry is not mentioned within the current Machinery Directive. Corresponding to the proposal a mandatory implementation of a new Conformity assessment procedure – as long as it is a matter of substantial modification - shall be explicitly added to the Regulation’s content, just as stated in article 12, passage 1 of the proposal: 
  
  In order to certify the conformity of a machinery product with this Regulation, the manufacturer or its authorised representative and the person who has carried out a substantial modification to the machinery product, shall apply one of the procedures for assessment of conformity (...)

High risk machines (corresponding Annex IV from the current Directive 2006/42/EC)

• The proposal states that the current listing from 2006/42/EC, Annex IV, is already 15 years old and should hence undergo an elaboration, as some of the machines mentioned can no longer be regarded as “high risk machines”
• However, new items should be added to the list such as "machinery embedding AI systems, which fulfil a safety function"
• For this kind of machinery, the proposal plans to establish mandatory relationships of the positions mentioned, even in the case of available harmonized standards: "only third-party certification will be accepted, even when manufacturers apply the relevant harmonised standards"

Paperless documents – digital instructions and digital declaration of conformity

• The proposal plans that instructions and declarations of conformity may be issued digitally and only need to be provided paper-based on customer request

Posted on: 28.04.2021