On 29 June 2023, the European Union approved the Regulation (EU) No. 2023/1230 of 14 June 2023 on machinery ("Machinery Regulation") replacing Directive 2006/42/EC which was published in the EU Official Journal. The Machinery Regulation standardises the essential safety and health protection requirements for the design and construction of machinery and related products across the EU as a whole. The major innovations entailed by the Machinery Regulation are as follows: the Machinery Regulation clarifies the scope of application of the norms on machinery and related products, encompassing – for instance – vehicles, electric bicycles, electric scooters, and other personal mobility devices. It provides a new definition of "safety component" that expressly includes software; hence, software that performs a safety function and is independently brought to market will have to be accompanied by an EU declaration of conformity and instructions for use, as well as bearing the CE marking. Furthermore, the Machinery Regulation makes third-party conformity assessment mandatory for six categories of machinery that pose high risks listed in Annex I; these include software with fully or partially self-evolving behaviour (machine learning). The Machinery Regulations will enter into force twenty days after their publication in the Official Journal of the EU.
Originally published by July, 2023
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