The EU Machinery Regulation which is expected to come into force in July 2023, and fully applicable after a transitional period of 42 months, will replace the existing Machinery Directive (2006/42/EC). The main aims of the new Machinery Regulation are:

• to further harmonise and update product safety requirements in the EU
• to cover the new risks linked to new technologies
• to continue to ensure people’s safety
• to ensure the free movement of products, including digital products.

The new Machinery Regulation will also bring about a number of changes from the previous directive, including:

• New definitions of terms and catalogues of obligations for manufacturers, importers, distributors and authorised representatives.
• More machinery will potentially be captured with a high risk/dangerous potential under Annex I of the new Machinery Regulation which has been expanded and will be constantly updated.
• Similar to the AI Regulation, notified body will do conformity assessment for CE marking for machinery listed in Annex I.
• If the machine uses safety-related AI, it falls under the category of (potentially dangerous) machinery in Annex I. The draft refers to "Machinery that has embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been placed independently on the market, in respect only of those systems".
• Speaking of AI, the Machinery Regulation brings new health and safety requirements for AI as well as more emphasis on cyber security. Under Article 20 of the Machinery Regulation Machinery and related products that have been certified or for which a statement of conformity has been issued under a cybersecurity certification scheme adopted in accordance with Regulation (EU) 2019/881 shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III, sections 1.1.9 and 1.2.1, as regards protection against corruption and safety and reliability of control systems insofar as those requirements are covered by the cybersecurity certificate or statement of conformity or parts thereof.
• Risk assessments are also introduced in relation to cyber attacks​, in order to ensure the safety of end users of equipment, and to avoid the most common problems associated with business continuity, reputational damage, and/or health and safety concerns​resulting from these deliberately malicious acts​​.
• The manufacturer is also obliged to ensure reasonable protection against accidental or deliberate attempts at corruption.
• (Partially) autonomous control systems must be designed in such a way that (i) they do not perform actions beyond the defined task and movement scope and (ii) it is possible to correct the machine at any time in order to maintain its inherent safety.
• A new obligation for the manufacturer to notify regulators of risks in the field, and there are added obligations on distributors.
• New Machinery Regulation will  not only cover physical components, but also digital components, or software, and might also capture systems that use artificial intelligence and machine learning technologies as well as automated guided vehicles. It will also apply to machinery that has undergone substantial modifications and software updates​​ are also included in the definition of substantial modifications.
• Several updates have also been added to the Essential Health and Safety Requirements such as:
  • The possibility for the user to test the safety functions
  • Ergonomics: the interface between Human and Machine
  • Protection against corruption
  • Several updates in the control system requirements
  • Addition of risk related to psychological stress

For more information please contact Dr Ian Gauci.