Cement
Energy-intensive and globally regulated, cement production faces growing demands for traceable emission reporting.
Product & Food Safety
Regulation — Machinery Directive (EU)
EU 2023/1230
Navigating the EU Machinery Regulation
The EU has fundamentally updated its product safety laws, replacing the Machinery Directive (2006/42/EC).
ARTEM provides the expertise and AI-driven tools to simplify this complex transition, ensuring your products are compliant from design to delivery.
ARTEM provides the expertise and AI-driven tools to simplify this complex transition, ensuring your products are compliant from design to delivery.
The Challenge: Shift from Directive to Regulation
1
What Has Changed?
The new Regulation, fully mandatory from January 20, 2027, strengthens and clarifies old rules with updated conformity procedures, a new focus on AI and cybersecurity, and the introduction of "substantial modification" rules.
2
Who Is Affected?
This impacts manufacturers, importers, distributors, and any company that substantially modifies existing machinery for the EU market.
3
What Is the Scope?
The Regulation applies to a wide range of products including machinery, interchangeable equipment, safety components (with AI), lifting accessories, and partly completed machinery.
Key Requirements of the Machinery Regulation
1
Risk Assessment & Mitigation
Conduct a thorough risk assessment according to EN ISO 12100 to identify all potential hazards and implement protective measures.
2
Conformity Assessment Procedure
Determine the machine's risk category to follow the correct conformity procedure, with stricter third-party involvement for high-risk machinery.
3
Comprehensive Technical File
Compile and maintain a detailed Technical File containing all design drawings, risk assessments, test reports, and compliance evidence.
4
EU Declaration of Conformity & CE Marking
Draw up and sign a legal declaration of conformity and place the CE mark visibly, legibly, and indelibly on the machinery.
Artem LEX™
Your Solution for Machinery Compliance
From Hardware to Strategy
Your Partner in Machinery Directive (EU) Compliance
