A recurring error in the industrial landscape is the belief that purchasing individually certified machinery exempts a company from further compliance obligations. However, when multiple CE-marked units are connected to operate in a coordinated manner, the regulations are clear: we are dealing with an ‘Assembly of machinery.’ In this scenario, safety is no longer just the sum of the parts, but the result of a complex integration that requires a new, global certification.

THE LEGAL CONCEPT OF “ASSEMBLY”

For a production line to be considered an ‘assembly,’ three elements must coexist: a production connection, operational linkage, and a common control system (e.g., a coordinating PLC). When these conditions are met, the entire line is regarded as a single ‘new’ machine. Individual certificates for the component units are no longer sufficient: a holistic overview is required, which only an expert can guarantee.

INTERFACE RISK ANALYSIS

The critical issue lies in the interfaces. A thorough analysis must evaluate what happens at the junction points: does an emergency stop on Machine A also ensure the safety of Machine B? The certification of the assembly serves to neutralize risks arising from the integration, verifying the compatibility of the control systems and the coordinated management of safety functions.

RESPONSIBILITIES AND OBLIGATIONS OF THE MANUFACTURER

Anyone who assembles the line legally assumes the role of the Manufacturer of the Assembly. This entails the obligation to draw up a new Technical File, issue a comprehensive EU Declaration of Conformity, and affix a new CE plate to the entire plant. Ignoring this step exposes the company to very serious civil and criminal liabilities in the event of an accident.

THE STRATEGIC SUPPORT OF ENTE CERTIFICAZIONE MACCHINE

In such a challenging bureaucratic and technical context, ECM stands as the ideal partner for manufacturers and integrators. We do not limit ourselves to simple verification: we offer high-profile technical support for interface risk analysis, conformity assessment according to the new standards of the Machinery Regulation, and all necessary testing activities. Thanks to our experience as a Notified Body, we support companies in drafting technical documentation, transforming a regulatory obligation into a guarantee of quality and safety that protects both investment and production continuity.