Standards

MR

Standards under the Machinery Regulation

The Regulation does not mandate standards. Harmonised standards and common specifications give a presumption of conformity with the Annex III requirements they cover (Art. 20); the requirements themselves are the law.

Article 20

Three routes to presumption of conformity

Each one covers only the requirements the standard, specification or certificate addresses. The rest of Annex III still has to be shown in the technical documentation.

Harmonised standards

Art. 20(1) and (2)

A product in conformity with harmonised standards, or parts of them, whose references are published in the Official Journal is presumed to conform to the Annex III requirements those standards cover. The Commission requests the European standardisation organisations to draft them.

Common specifications

Art. 20(3)

Where harmonised standards are missing or insufficient, the Commission may adopt implementing acts with common specifications; conformity with them gives the same presumption for the requirements they cover.

Cybersecurity certificates

Art. 20(9)

Machinery certified, or with a statement of conformity, under a cybersecurity certification scheme adopted under Regulation (EU) 2019/881, once the scheme references are published, is presumed to conform to Annex III sections 1.1.9 and 1.2.1 insofar as the certificate covers them.

Which standards are harmonised under the Regulation follows from the references the Commission publishes in the Official Journal. This site does not keep that list.

What Crosswalk uses

Two guidance documents for the cyber sections

For Annex III sections 1.1.9 and 1.2.1, Crosswalk maps its controls to two documents from the machinery-safety world. They help structure the work; they do not carry presumption of conformity.

ISO/TR 22100-4

Safety of machinery, relationship with ISO 12100, part 4

Guidance to machinery manufacturers for consideration of related IT-security (cyber security) aspects

A technical report: guidance on how IT security relates to the ISO 12100 risk assessment. Not a harmonised standard.

IEC TS 63074

Safety of machinery, security aspects related to functional safety of safety-related control systems

Technical specification

How security threats and vulnerabilities bear on safety-related control systems. Not a harmonised standard.

Standards stay voluntary; the law is the binder

Crosswalk assesses against the articles and shows which standards you already use serve which requirement.

Still Feeling Overwhelmed?

EU cybersecurity laws can be complex. Our free tools and guides work great for most people, but if you're dealing with something particularly challenging or have tight deadlines, we're here to help.