Last month, the European Commission published its evaluation of the Machinery Directive (Directive 2006/42/EC, as amended), examining whether it remains fit for purpose, particularly in light of emerging technologies such as Artificial Intelligence ("AI") and the Internet of Things ("IoT").
The first Machinery Directive was adopted in 1989; the current (third revision) came into force in 2009. It is the main piece of EU regulation in the mechanical engineering and industrial products space and its scope is broad – covering everything from lawnmowers to 3D printers, hand-powered tools to bulldozers, household robots to automated industrial production lines.
Under the Machinery Directive, manufacturers must design products to meet essential health and safety requirements ("EHSR"). European harmonized standards are voluntary, but adopting them creates a presumption of compliance with EHSR. Regardless of approach, manufacturers must produce a technical file, sign a Declaration of Conformity and affix a CE marking to all products (in most cases by means of self-assessment).
Results of the Evaluation
The Commission's view is that the manufacturing industry is leading the way when it comes to key emerging technologies, creating a "fourth industrial revolution" whose distinctive features are "technological breakthroughs" in areas like robotics, IoT and AI. The Commission expects the market value of just IoT in the EU to exceed one trillion euros in 2020.
Despite the pace of change, the Commission found that the Machinery Directive remains "generally relevant, effective, efficient, coherent and has EU added value". However, it had some reservations.
- The Commission thinks there is a need for greater legal clarity in the Machinery Directive's scope and definitions, and better coherence with other legislation such as the Low Voltage Directive.
- Market surveillance and enforcement of non-compliance is ineffective, according to the Commission, and the mechanisms of accreditation and monitoring of Notified Bodies insufficient. It is working on a proposed Regulation to tackle these issues.
- The Commission found the Machinery Directive had coped well with innovations since 1989, and remained fit for purpose at present, but was "widely perceived as being less able to deal with coming emerging digital innovations".
The Commission's evaluation of the Machinery Directive is one of a raft of initiatives it has launched in response to rapid industry modernisation, including measures on artificial intelligence, a strategy on connected and automated driving, and a parallel evaluation of the Product Liability Directive.
In considering whether the Machinery Directive remains fit for purpose, the Commission recognises the challenges posed by new technologies and the need for greater legal clarity and coherence. Yet it is notable that the Commission's evaluation does not suggest that there is any need for legislative amendment, or further guidance – in contrast to the Product Liability Directive, where it has established Expert Groups (including Cooley's Rod Freeman) to help prepare guidance in the context of emerging technologies.
This suggests that, overall, the Commission thinks that the Machinery Directive has come out of its first health check reasonably well. However, given the pace and type of change, the real tests for EU machinery legislation are likely to lie ahead. To that end, the Commission's recent announcement that it will launch a study into aspects of emerging technologies not explicitly addressed by the Machinery Directive, such as human-machine collaboration, should be welcomed.
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