In particular, the revision of the MD intends to address the following issues: (i) the MD does not sufficiently cover new risks originating from emerging technologies; (ii) legal uncertainty due to a lack of clarity on the scope and definitions; and possible safety gaps in traditional technologies; (iii) insufficient provisions for high risk machines; (iv) monetary and environmental costs due to extensive paper-based documentation; (v) inconsistencies with other pieces of Union product-safety legislation; and (vi) divergences in interpretation due to transposition.

The general objectives of the MD are to: (i) ensure free movement of machinery within the single market; and (ii) ensure a high level of protection for machinery users and other exposed persons. The REFIT evaluation of the MD (SWD (2018)160) concluded that the Directive is generally relevant, effective, efficient and coherent. The evaluation also concluded that the MD has EU added value, but it argued that the MD needed specific improvements and simplification. The evaluation stated that the MD enables technological developments in the digital era, given that the MD is underpinned by the ‘new approach’ principles (the ‘new approach’ means that legislation sets mandatory basic requirements, leaving standardisers organisations to set the technical details needed to meet those requirements). However, the evaluation argued that further analysis of the MD is needed to assess its effectiveness and fitness for purpose in the future. This further analysis should cover developments in digitalisation, such as the internet of things, artificial intelligence (AI), and the new generation of autonomous robots.

As part of the Commission Work Programme 2020 under the priority ‘A Europe fit for the Digital Age’, the Commission plans to revise the Machinery Directive (‘the MD’, Directive 2006/42/EC). This revision contributes to both the digital transition and to the strengthening of the single market. In February 2020, the Commission published a white paper on artificial intelligence accompanied by a report, Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and robotics. The report concluded that the EU’s current product-safety legislation – in particular the MD – contains a number of gaps that need to be addressed.

These general objectives translate into the following six specific objetives: (i) cover new risks related to digital emerging technologies; (ii) ensure coherent interpretation of the scope and definitions and improve safety for traditional technologies; (iii) reassess machines considered as high risk and reassess related conformity procedures; (iv) reduce paper-based requirements for documentation; (v) ensure coherence with other NLF legislation; and (vi) reduce possible divergences in interpretation derived from transposition.

The MD is a piece of product-safety legislation that aims to ensure a high level of protection for workers, consumers and other exposed persons by focusing on the safety of machinery itself, and thus imposing obligations on machinery manufacturers to design and construct inherently safe machinery (safety by design). This initiative intends to revise the MD so that it can continue fullfilling its objectives by: (i) ensuring a high level of safety and protection for users of machinery and other people exposed to it; and (ii) establishing a high level of trust in digital innovative technologies for consumers and users, thus ensuring a level playing field for economic operators and preserving the competitiveness of the machinery sector in global digital markets.

The MD is a key driver of safety for machinery users in the EU. As already mentioned, the main objectives of the MD are to ensure a high level of health and safety protection for these users, and to allow the free circulation of machinery in the EU. In particular, the MD helps reduce social costs by preventing accidents that may be caused by the use of machinery. A key rationale for an EU-level machinery directive is to provide harmonisation across Member States based on Article 114 TFEU. Any changes to the MD’s scope or requirements must be made at EU level to avoid distorting the market, creating barriers to the free movement of products and undermining the protection of human health and well-being.

The machinery sector is a highly relevant part of the engineering industry and one of the industrial drivers of the EU economy. In 2017, the machinery sector recorded turnover of EUR 663 billion, production of EUR 609 billion, and a value added of EUR 191 billion. The total EU machinery and equipment exports amounted to EUR 503 billion, of which 49% were exported to EU Member States (i.e. intra-EU exports), while 51% were exported to countries outside the EU (extra-EU exports).