Machinery Regulations

The new Machinery Regulation (EU) 2023/1230 comes into force from 20 January 2027, and replaces the current Machinery Directive 2006/42/EC. The Regulation was published in June 2023 and will apply from 20 January 2027. From that date, machinery and related products placed on the EU market will need to comply with the new Regulation rather than the existing Directive.

The official Regulation can be found on the European Commission website here.

Although many core machinery safety principles remain familiar, the new Regulation introduces important updates. These updates not only amend the technical design aspects covered under the Annex sections of the Machinery Directive; they also significantly change the ‘administration process’ relating to the documentation and supply of products to market.

Significant changes from Directive to Regulation include emphasis on cybersecurity, software, artificial intelligence, digital documentation, and revised conformity assessment requirements for certain higher-risk machinery categories.

One key aspect of the move from Directive to Regulation is the requirement of establishing someone based in the EU to act as a legal point of contact. Whilst having someone responsible as a point of contact in Europe was included in the 2006 Machinery Directive it has now been brought in-line with other, more recently updated directives (LVD, EMC, etc, etc.), as part of a more structured definition of Economic Operators.

Machinery is defined as any product that contains a linkage of parts that moves under power for a purpose. It also covers assemblies that aren’t whole machines, and groups of assemblies or machines that function together for a common purpose.

Key points for consideration

• Identify all products that will fall under the scope of the new Regulation.
• Check whether any machinery may be affected by revised high-risk categories or mandatory third-party conformity assessment.
• Review the risk assessment to ensure cybersecurity, software integrity and digital safety functions are properly addressed.
• Update all technical documentation, instructions for use and declarations where required.
• Review economic operator status for you supplier chain.
• Planning early with suppliers, notified bodies and internal engineering teams to avoid last-minute compliance issues.

We understand this review/update process may fall on already stretched internal resources within your company and so in practical terms, we can step in as your support team. Working as your collaborative partner on the transition from Directive to Regulation will allow you to concentrate on product development and leave us to cover the legislative requirements.