The new Machinery Regulation and its implications for the machinery industry.
The initial motivation for revision of the Machinery Directive (Directive 2006/42/EC, MD) was to promote innovation in the EU's economy and bring European legislation into the 21st Century. The background was an evaluation of the MD in summer of 2018 (as we reported) which generally concluded that the MD is relevant, efficient and coherent and that it enables technological development in the Digital Age. But at the same time, it identified the need to define the Directive's material scope more clearly, particularly in distinction with other harmonization legislation, to integrate the MD into the New Legislative Framework and to reduce administrative work by simplifying documentation requirements. It also called for adapting the MD to meet the requirements posed by the progressive digitization of the machinery industry in the Internet of Things (IoT), and with regard to artificial intelligence (AI) and the latest generation of autonomous robots.
In addition to the Commission's Proposal for a Regulation laying down harmonized rules on artificial intelligence, the EU Commission has also presented a proposal for a Machinery Regulation which is designed to address the results of the evaluation.
The proposal expands the material scope to include machinery missing only the upload of software which is required for its specific intended use. In contrast to other harmonization legislation, the Regulation now expressly states that electrical and electronic products within the material scope of the Low-Voltage Directive (Directive 2014/35/EU) (PDF) and Directive 2014/53/EU (PDF) on radio equipment are not covered by the MD. Machinery containing artificial intelligence systems will only be covered by the MD to the extent necessary for safe and constructive integration of the AI systems into the larger machinery.
The Regulation also defines a number of new terms, such as "safety component," which now includes software as well as physical products, "artificial intelligence system" and "substantial modification," which now includes both physical and software-induced product changes. The definitions in the MD have also been adapted to conform with the specifications of Decision No. 768/2008/EC, as well as the general duties of economic operators and the specifications concerning the presumption of conformity, the EU Declaration of Conformity and the CE marking.
In the future, manufacturers will be able to provide users with their EU Declaration of Conformity by including an internet address in the instructions for use at which they can view the full declaration. The instructions for use themselves can also be provided in digital form only in the future, and need only be provided in paper form at the buyer's request.
In addition, the list of machinery posing an elevated health risk to users has been moved to Annex I and adapted to conform with technological progress. The essential health and safety requirements for machinery will now be dealt with in Annex III and now include rules for the design of controls for automated machinery as well as for the safe wiring of machinery.
As far as can be seen, the revised MD addresses the aspects which were found to be in need of revision based on the evaluation. It ensures coherence with existing product safety legislation and with the future Regulation on artificial intelligence, defines new requirements for machinery operated in a digital environment and provides manufacturers with some administrative relief through the digitization of product information. It remains to be seen whether the parallel development of harmonized legislation can keep up with the pace of technological progress.