Machinery Conformity Assessment

Conformity Assessment of Machinery and Partly Completed Machinery in Accordance with Directive 2006/42/EC

Our company provides comprehensive services in the field of machinery and assembly conformity assessment, specializing in adapting production lines to the requirements of Directive 2006/42/EC and other applicable directives. We understand the challenges faced by companies acquiring advanced technological lines that include machinery and installations subject to multiple 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 national legislation. Our knowledge of the specific nature of these complex systems enables us to effectively support our clients, particularly when they are faced with the need for a comprehensive CE conformity assessment of the entire production line — a task which is often unexpectedly complex and transferred to them through supplier contracts.

Our Approach:

Assessment Strategy Design: At the outset, we review the provided documentation and conduct an on-site inspection to develop the most efficient conformity assessment method. The assessment plan outlines the machine description, applicable standards and reference regulations, the assessment pathway, and execution method.
Risk Assessment: In cooperation with the client, we carry out a machinery risk assessment in accordance with PN-EN ISO 12100 to the extent required to demonstrate conformity with health and safety requirements.
Control System Evaluation: We assess the control system in terms of safety requirements according to the PN-EN 60204 series. This includes assigning appropriate SIL or PL levels for identified safety functions and validating compliance using PN-EN 62061 or PN-EN ISO 13849.
Conformity Assessment: We work hand in hand with our clients throughout the entire conformity assessment process. We present the scope of required actions and the list of documentation needed during the design, assembly, and testing phases. We participate in negotiations with client suppliers to obtain the necessary documents and corrective actions arising from the risk analysis.
Cooperation with a Notified Body: For machinery falling under specific directive requirements (e.g., Annex IV), we cooperate with the Notified Body (NoBo) on behalf of the client.
Declaration of Conformity: After completing the conformity assessment, we prepare a Declaration of Conformity, including the required annexes, ready for client signature and submission for placing the machinery on the EU market.
Declaration of Incorporation: For partly completed machinery, we prepare a Declaration of Incorporation along with the required annexes for placing the partly completed machinery on the EU market.

If you need assistance in carrying out a conformity assessment for your machinery, contact us — we’ll guide you through the entire process.