What Machine Manufacturers Need to Know About the Machinery Regulation

From 20 January 2027 the EU Machinery Regulation (EU) 2023/1230 will apply, replacing the current Machinery Directive 2006/42/EC. For machine manufacturers, the change affects several areas of machinery compliance, including risk assessment, technical documentation, cybersecurity and the Declaration of Conformity.

What changes on 20 January 2027?

Which legislation applies depends on when machinery is placed on the market or put into service. Machinery Directive 2006/42/EC continues to apply until 19 January 2027, while Machinery Regulation (EU) 2023/1230 applies from 20 January 2027.

This is a clear changeover rather than a period where manufacturers can choose between the two. Machine manufacturers therefore need to ensure that their machinery and documentation meet the applicable requirements from 20 January 2027.

What changes under the new Machinery Regulation?

The Machinery Regulation introduces new and updated requirements in areas including cybersecurity, safety-related software, digital instructions, substantial modifications and higher-risk machinery. It also updates parts of the essential health and safety requirements in Annex III.

The impact will depend on the machinery, its intended use and the manufacturer’s role. Machine manufacturers should therefore identify which requirements apply to their products and update their risk assessment, technical documentation and Declaration of Conformity accordingly.

Reviewing the risk assessment process

Machine manufacturers should review their risk assessment process and templates to ensure they reflect the new and updated requirements.

This includes considering risks related to new technologies and connected machinery, as well as relevant changes to the essential health and safety requirements in Annex III. The findings should be reflected in the machinery’s design, technical documentation and the protective measures selected for the machinery.

Reviewing technical documentation

The Machinery Regulation also introduces changes that affect the technical documentation for machinery. Manufacturers should review their documentation to ensure that it reflects the applicable requirements under the Regulation.

This includes documenting the risk assessment and the protective measures applied, as well as relevant information on safety functions and their testing. The technical documentation should demonstrate how the machinery meets the applicable essential health and safety requirements in Annex III.

Updating the EU Declaration of Conformity

The move from the Machinery Directive to the Machinery Regulation also brings changes to the EU Declaration of Conformity. Manufacturers should review both the regulatory reference and the information included in the declaration.

For machinery placed on the market or put into service from 20 January 2027, the declaration needs to refer to Machinery Regulation (EU) 2023/1230. The Regulation also introduces changes to the required content of the declaration, making it important to review existing templates and processes ahead of the changeover.

Preparing for cybersecurity requirements

Cybersecurity becomes more closely connected to machinery safety under the Machinery Regulation. Manufacturers must assess whether digital connections, software or other components could be manipulated in a way that affects the safe operation of the machinery.

Where cybersecurity risks can affect machinery safety, they must be addressed as part of the risk assessment and reflected in the machinery’s design and protective measures. For connected machinery, the requirements of the Machinery Regulation also need to be considered alongside other relevant EU legislation, including the Cyber Resilience Act (EU) 2024/2847 (CRA).

Organising product compliance responsibilities

The Machinery Regulation defines responsibilities for manufacturers, importers and distributors involved in placing machinery on the EU market. Anyone involved in making, importing or supplying machinery should therefore confirm which economic operator role they have and which obligations apply.

Product compliance needs to be organised and managed across the relevant functions within the organisation. This includes ensuring that applicable requirements are identified, conformity procedures are followed and the necessary documentation is maintained. A structured approach to product compliance also makes it easier to manage future regulatory changes.

What about the UK?

The UK follows its own machinery safety legislation and is not directly covered by the EU Machinery Regulation. However, in June 2026, the UK adopted a revision of its Supply of Machinery Regulations 2008 that incorporates requirements from the Machinery Regulation into UK law.

For machine manufacturers supplying both the EU and UK markets, this makes things easy, because the core requirements are aligned. Only few differences regarding market need to be considered.

Machinery Regulation 2027 checklist

Before 20 January 2027, machine manufacturers should make sure that they have reviewed:

• Which changes in the Machinery Regulation apply to their machinery
• Existing risk assessments and relevant Annex III requirements
• Technical documentation and safety function testing
• EU Declaration of Conformity templates and processes
• Cybersecurity risks that could affect machinery safety
• How product compliance is organised and managed internally