The Machinery Directive 2006/42/EC was the basis for machine safety in Europe for almost twenty years. Its successor is a regulation, applying without national transposition, and it reflects developments that barely existed in 2006: connected machines, software as a safety function and systems using machine learning.
What is new
Manufacturers must protect machines against corruption, preventing manipulation of hardware or software from leading to hazardous situations. Software performing safety functions and safety components with self-evolving behaviour are expressly covered; certain categories require assessment by a notified body. Instructions may be provided digitally, but a paper version must be supplied if requested at the time of purchase.
Interplay with other rules
For connected machines, the Cyber Resilience Act and the EU Data Act apply in parallel, and for software the new Product Liability Directive as well. Harmonised standards help achieve the presumption of conformity.
Swiss manufacturers
For exports to the EU the regulation applies regardless of the manufacturer’s seat. Manufacturers should follow how Switzerland adapts its own law through the competent federal authorities. A compliance assessment maps the duties per machine family.