normakte  /  Assemblies of machinery

Complete plants: one declaration for machinery, pressure equipment and ATEX

Whoever combines several machines into a plant that works as a whole is the manufacturer of that assembly. From 20 January 2027 the Machinery Regulation applies to it – with new particulars in the declaration and evidence spread across many suppliers.

When a plant is an assembly

An assembly of machinery exists when several machines, partly completed machines or both are arranged and controlled so that they function as an integral whole – typically with a common control system and common safety functions. Whoever puts it together takes on the manufacturer's obligations for the assembly.

Art. 3(1)Art. 10

What belongs in the plant's file

DocumentWhere it comes from
Risk assessment of the assembly, especially the interfaces: emergency stop, cross-machine safety functions, control systemyour own work
Declarations of conformity of the purchased complete machinessuppliers
Declarations of incorporation and assembly instructions of the partly completed machinessuppliers
Evidence for pressure equipment and assemblies, equipment for explosive atmospheressuppliers and your own assessment
Instructions for the complete plantyour own work
One EU declaration of conformity for the assemblyyour own work

One declaration for all acts

This obligation is not new: the directives aligned with the New Legislative Framework, such as the Pressure Equipment and ATEX Directives, have required it since 2016, and the Machinery Regulation adopts it explicitly. If more than one act requiring an EU declaration of conformity applies to the plant, a single declaration is drawn up that names them all – for example the Machinery Regulation, the Pressure Equipment Directive 2014/68/EU and the ATEX Directive 2014/34/EU. Each act keeps its own requirements and conformity assessment procedures. If the control system has a network connection, the Cyber Resilience Act is added from 11 December 2027.

Art. 21(3)Annex V

Whether a plant counts as an assembly and which acts apply in detail depends on its actual design; the legal texts and the Commission's guides are authoritative.

One file per plant

Suppliers' declarations, your own evidence and the overall declaration in one place – with the article reference for each requirement. Trial file free until 20.01.2027.

Open a trial file

Read next

Sources. Regulation (EU) 2023/1230, OJ L 165 of 29.6.2023; Regulation (EU) 2024/2847, OJ L, 2024/2847 of 20.11.2024. Summarised; only the official text is authoritative. normakte is not legal advice.