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Robot cell integration and substantial modification under Regulation 2023/1230

Integrators who build a robot cell or modify an existing line need to know when they take on the legal role of manufacturer. This page explains what the Machinery Regulation says about assemblies of machinery and substantial modification.

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Answers are written by a language model solely from this base's documents, with numbered sources. They can be wrong and aren't legal, medical or financial advice: check the sources before any important decision.

A robot cell can be machinery in its own right

The Regulation's definition of machinery includes assemblies of machinery, or of partly completed machinery, which, to achieve the same end, are arranged and controlled so that they function as an integral whole. A robot combined with peripheral equipment into one cell can fall under this definition.

Annex III requires the safety-related parts of the control system to apply in a coherent way to the whole of such an assembly. A manufacturer is also defined as anyone who manufactures products in scope and puts them into service for their own use.

When a modification makes you the manufacturer

A substantial modification is a physical or digital modification, made after the machine was placed on the market or put into service, that the manufacturer did not foresee or plan and that affects safety by creating a new hazard or increasing an existing risk. It must also require either adding guards or protective devices that need changes to the existing safety control system, or additional measures for stability or mechanical strength.

Whoever carries out a substantial modification is considered a manufacturer and takes on the obligations of Article 10. If the modification affects only one machine within an assembly, as shown by the risk assessment, those obligations apply to that machine only. A non-professional user modifying their own machine for their own use is not treated as a manufacturer.

Integrator duties in the US

The OSHA Technical Manual identifies Part 2 of ANSI/RIA R15.06-2012 as the safety standard for integrating robot systems. Integrators must carry out hazard analyses and risk assessments for each application, ideally with the employer and workers.

OSHA suggests that employers include ANSI/RIA R15.06-2012 and RIA TR R15.606-2016 compliance in the statement of work of the integration contract, then verify compliance, usually during site acceptance.

Frequently asked questions

Does a digital change, such as new software, count as a substantial modification?

It can. The definition covers modifications made by physical or digital means. The modification must still be unforeseen by the manufacturer, affect safety, and require changes to the safety control system or added stability or strength measures.

What must the person who substantially modifies a machine declare?

They must ensure and declare on their sole responsibility that the machine conforms with the Regulation. They must also apply the relevant conformity assessment procedure under Article 25(2), (3) and (4).

What does a supplier of partly completed machinery provide?

An EU declaration of incorporation, with technical documentation demonstrating the relevant essential requirements. Both must be kept for at least 10 years. The declaration accompanies the product, or its internet address or machine readable code is given in the assembly instructions.

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