Conformity Assessment of Machine Assemblies and Production Lines

Conformity Assessment of Machine Assemblies and Production Lines in Accordance with Directive 2006/42/EC and Other Applicable Directives

Our company provides comprehensive services in the field of conformity assessment for machinery and machine assemblies, specializing in adapting production lines to the requirements of Directive 2006/42/EC and other relevant directives. We understand the challenges faced by companies acquiring technologically advanced lines that include machines and installations subject to a variety of regulations, including the Machinery Directive (MD) 2006/42/EC, Pressure Equipment Directive (PED) 2014/68/EU, Low Voltage Directive (LVD) 2014/35/EU, ATEX Directive 2014/34/EU, as well as equipment governed by national legislation. Our in-depth knowledge of these complex systems enables us to effectively support our clients — especially when they are faced with the need to carry out a full CE conformity assessment of an entire production line, which often turns out to be surprisingly complex and is transferred to them under supplier contracts.

Our Approach:

Assessment Strategy Design: At the beginning of the process, we analyze the provided documentation and conduct an on-site visit to design the most effective method for assessing the conformity of the entire production line. The strategy outlines the component systems, applicable standards and reference regulations, the assessment pathway and method, and the responsibilities of each stakeholder involved in the project — including designers, equipment suppliers, installers, and supervisors.
Risk Assessment: Together with the client, we perform a risk assessment of the machinery and its assemblies in accordance with PN-EN ISO 12100, to the extent necessary to demonstrate that the newly established line meets all health and safety requirements.
Conformity Assessment: We guide our clients through the entire conformity assessment process. We define the necessary actions, list the required documentation from designers, contractors, and suppliers, and participate in discussions with suppliers to obtain the necessary documents and corrective actions identified through the risk analysis.
Control System Evaluation: We evaluate the control system for compliance with safety requirements based on the PN-EN 60204 series. We assign the required SIL or PL levels to identified safety functions and validate compliance using PN-EN 62061 or PN-EN ISO 13849.
Pressure Equipment Assessment: If the production line includes pressure equipment or pressure assemblies subject to the PED, we classify these assemblies and assist in safely navigating the conformity assessment process with Notified Bodies (NoBo), depending on the project’s needs.
Assessment of Additional Requirements: For existing machinery or equipment not subject to EU directives, we perform an evaluation of compliance with minimum requirements, enabling their inclusion in the assessed assembly.
Declaration of Conformity: Upon completion of the conformity assessment, we prepare a Declaration of Conformity for the client to sign, along with an annex confirming compliance with essential health and safety requirements and the proper introduction of the production line to the EU market.

Why Choose Us?

Our services are tailored especially for companies faced with the demanding task of global conformity assessment of complex production lines that include components with varying levels of regulatory oversight. With our support, this process becomes significantly simpler and more predictable, allowing for efficient implementation of the required actions without unnecessary delays or surprises.
Trust our experience and professionalism — we will ensure that your production line meets all legal requirements and complies with the highest safety and quality standards.