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Machinery Regulation - Information for manufacturers

On 29 June 2023, Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive (EU) 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC was published in the Official Journal of the European Union.

This Regulation will create a legal framework for the placing on the market and putting into service of machinery. It will be directly binding on Member States and all economic operators, including manufacturers, importers and distributors in EU Member States. It will be implemented in the Czech legal system by adapting Act No. 90/2016 Coll., on the assessment of conformity of specified products when they are placed on the market, as amended. At the same time, the existing Government Regulation No. 176/2008 Coll., on technical requirements for machinery, as amended, will be repealed.

Specifically, the obligations of manufacturers of machinery and related products are regulated in particular by Article 10 and those of manufacturers of incomplete machinery by Article 11 of this Regulation.

Annex III with essential health and safety requirements takes into account the risks associated with digitalisation and new technologies.

The Regulation will allow manufacturers to provide instructions for use of machinery in digital form. However, the user will be able to request a printed manual from the manufacturer free of charge at the time of purchase. For machinery for non-professional users, the manufacturer will provide safety information in written form.

The Machinery Regulation will be directly applicable from 19 January 2027. EC type-examination certificates and approval decisions issued in accordance with the current Directive 2006/42/EC for machinery will remain valid until their expiry date.

Articles 26 to 42 of the Regulation, which concern the notification of conformity assessment bodies, apply already 6 months after the date of entry into force of the Regulation.

Main changes to the EP and Council Regulation (EU) 2023/1230 compared to the existing Directive 2006/42/EC:

  1. Alignment with the new legislative framework:
    • Definition,
    • obligations of economic operators,
    • reporting.
  2. Scope:
    • exclusion of vehicles covered by specific EU rules.
  3. Introduces a new term - related products:
    • include interchangeable attachments; safety components; lifting accessories; chains, ropes and belts; removable mechanical transmission devices.
  4. Definition of safety component:
    • a physical or digital component, including software.
  5. Significant change in machinery:
    • the definition and duties of the person who carries it out.
  6. Digitalization and new technologies:
    • Risk assessment of autonomous machines and machines with self-developing behaviour using machine learning approaches (with artificial intelligence),
    • cyber safety - in a remote-controlled machine, a communication failure or faulty connection must not lead to a dangerous situation,
    • adaptation of basic requirements to the operator/user (psychological load, machine information about planned events,
    • surveillance functions for autonomous mobile machines,
    • reliable and safe control systems for machinery with embedded systems with fully or partially self-learning behaviour using machine learning approaches.
  7. Power of the European Commission to issue common specifications.
  8. "high risk" machinery - categorisation into 2 parts:
    • Part A - 6 categories (mandatory participation of notified body in conformity assessment),
    • Part B - 19 categories,
    • clearly defined conditions for the review of these categories of machinery.