A very common mistake in the industrial sector is assuming that purchasing machinery with individual certificates exempts the company from further bureaucratic and safety obligations. In reality, when multiple CE-marked devices are interconnected to operate in a coordinated manner, the legislation shifts perspective and defines this configuration as a fully-fledged “Assembly of machinery.” In this context, overall safety is not simply the sum of individual certifications; rather, it requires a comprehensive global assessment and a new declaration of conformity.

WHEN DOES A LINE BECOME AN “ASSEMBLY”?

To meet this regulatory definition, three fundamental factors must coexist: a production link, operational continuity, and a centralized control system (such as a coordinating PLC). If these conditions are met, the entire plant is treated as a single large machine. This applies both to newly installed production lines and to existing ones made available to workers. Consequently, the individual units’ old certificates are no longer sufficient to guarantee legal compliance.

THE CRITICAL ROLE OF INTERFACE RISKS

The real safety challenge is concentrated at the junction and interaction points between the various machines (the so-called interfaces). A proper risk analysis must establish precisely what happens during operation: for example, whether activating an emergency stop on machine “A” instantly and safely stops machine “B” as well. Certifying the assembly means mapping and eliminating the risks arising from combining these different elements, ensuring that the control systems communicate correctly.

RESPONSIBILITIES AND OBLIGATIONS OF THE MANUFACTURER

Anyone assembling the line legally assumes the role of Manufacturer of the Assembly. This entails the obligation to draw up a new Technical File, issue an overall EU Declaration of Conformity, and affix a new CE plate to the entire plant.

To draw up the Declaration of Conformity, it is necessary to comply with the requirements contained in Annex II of the Machinery Directive (2006/42/EC).

In particular, the document must include:

• The Manufacturer;
• The person authorized to compile the technical file within the EU;
• The signatory of the Declaration of Conformity.

The signatory of the Declaration of Conformity assumes the burden and liability for ensuring the machine’s compliance with safety requirements for as long as the machine is on the EU market.

THE STRATEGIC SUPPORT OF ECM

It is therefore essential to rely on a Notified Body such as ECM, which guides the company through the bureaucratic process by drafting rigorous reports. This ensures that the person signing the Declaration of Conformity can do so with the full support of a team of subject-matter experts.