Machinery Regulation (EU) 2023/1230

Intertek offers a range of services to help you ensure compliance with the latest safety and regulatory standards. Whether you're manufacturing traditional industrial machinery or developing new AI-powered systems, we provide tailored support to streamline your compliance journey. 

To support this, we offer a structured, yet flexible Compliance Readiness Program (CRP) designed to ensure clarity and efficiency throughout your compliance journey — whether you're just getting started or preparing for final product assessment. No matter your timeline, our expert team provides hands-on guidance every step of the way. 

The process is streamlined into clear stages to simplify your experience: 

CFR – Compliance Feasibility Review A combined entry-stage offering that covers:  

•  Initial feasibility assessment 
•  Standards screening and mapping 
•  Preliminary design review 
•  Review of early observations and potential deviations

This modular step allows you to select one or all of these services based on your needs, providing flexibility while keeping the process simple and intuitive. 

Stage 2 – Prototype and physical product evaluation 

Stage 4 – Pre-compliance and final testing 

Stage 5 – Reporting and Voice of the Customer (VoC) 

Stage 6 – Project closure and compliance readiness 

This systematic process supports early risk identification, targeted improvements, and efficient preparation for certification or market launch. 

• Technical file support: We support you in compiling and organizing the necessary documentation for your technical file, helping ensure it meets the requirements for demonstrating compliance – while you remain fully responsible for its content and maintenance.
• Manual development support: We assist in structuring and reviewing your installation, operating, and maintenance manuals to help ensure they align with the latest digital format and safety requirements – while you remain responsible for authorship and final content.
• Risk assessment support: We support you in conducting risk assessments in line with EN ISO 12100, including considerations for emerging technologies such as cyber security. The final assessment and responsibility remain with the manufacturer.
• Site inspection: On-site assessments to ensure compliance with the new regulation.
• Machinery safety standards support: We assist you in verifying compliance with key European safety standards such as EN 60204-1 (electrical safety), EN ISO 13849-1/2 (functional safety), EN ISO 13855 (safety distances), EN 619 (industrial conveyors), and EN 528 (storage and retrieval systems).  
• Verification of structural calculations: Assessing the structural integrity of machinery to meet regulatory standards.
• Design reviews: Detailed review of your machinery design to help ensure alignment with the Machinery Regulation and relevant harmonized European standards, supporting compliance with applicable safety, AI, and cybersecurity requirements.
• Guidance on Compliance with EHSRs: Expert advice on meeting the Essential Health & Safety Requirements (EHSRs) of the Machinery Regulation.
• Notified Body Services under Annex I: We offer conformity assessment services for high-risk machinery categories listed in Annex I of the Machinery Regulation. We aim to support manufacturers with the applicable requirements from Part A and/or Part B, subject to our formal designation as a Notified Body.
• Technical file handling for EC Type-Examination: For machinery requiring EC type-examination under the Machinery Regulation, we manage the required retention and registration of technical documentation as part of our role as a Notified Body – where applicable.
• Review of Design, Purchasing & Inspection Protocols: Ensure all processes meet the updated requirements for risk mitigation and safety.
• AI and Cybersecurity risk evaluation: We support you with guidance on integrating AI risk assessment, including bias, transparency, and safety, along with cybersecurity controls aligned to international and harmonized standards where available.
• Assessment of AI-based functions: We support you with evaluating AI-based or AI-integrated components (e.g. vision systems, predictive controls, adaptive behaviour) for compliance with requirements under the Machinery Regulation and EU AI Act.
• Cybersecurity testing: Evaluation of yourmachinery’scybersecurity posture through vulnerability testing, cybersecurity controls evaluation, and assessment of secure-by-design principles including certification to standards such as IEC 62443 and alignment with applicable cyber regulations such as the RED Delegated Regulation (2022/30) and Cyber Resilience Act (2024/2847). 
   
  The CRA sets strict security and reporting requirements for products with digital elements that expands on the scope of products considered under the RED and builds on top of the RED requirements. We offer CRA educational seminars, guidance on risk assessment processes, and product testing, verifying you’ve built-in strong cyber processes and defences and that you are ready to meet the upcoming regulatory requirements and stay ahead of evolving threats. 

In addition to the Machinery Regulation, Intertek is a Notified Body for various other EU Directives and Regulations, including: 

• Low Voltage Directive (2006/95/EC)
• Electromagnetic Compatibility (EMC) Directive (2004/108/EC)
• Gas Appliance Directive
• Explosive atmospheres (ATEX) Directive (2014/34/EU) 
• Medical Device Directive (93/42/EEC)
• Outdoor Noise Directive
• Radio Equipment Directive (RED) 
• Radio Equipment Directive (RED) 2014/53/EU 
• Cyber Resilience Act (CRA) 2024/2847/EU 
• Boiler Efficiency
• Pressure Equipment Directive (PED) 2014/68/EU 
• Use for Work Equipment (UWED) 2009/104/EC