Customized productions demand intricate conformity assessment processes!

Specifics in the conformity assessment and CE marking of special machinery and equipment

  • Special machines are specifically designed and manufactured according to customer requirements, often as a unique development or a customized adaptation of a standard machine. Plants are also customized to meet specific overall process requirements. They involve combining various individual machines and technical components to create a new machine system. Due to the low quantity produced, the development, production, and documentation processes are typically associated with significantly increased effort.
  • Conformity assessment and CE marking are also more complex and demanding in their creation, since rarely routine and standardized procedures and documentation can be applied.. easyCE also observes that often a special assessment according to regulations such as ATEX 2014/34/EU, EMC, and Pressure Equipment 2014/68/EU needs to be conducted.
  • In plant construction, assigning responsibility for the conformity assessment of the combined machine is often challenging, this is why it is advisable to engage an external service provider and distribute the costs fairly across the entire project.
REFERENCE PROJECTS

REFERENCE PROJECTS

easyCE has years of experience in the conformity assessment and CE marking of special machinery and manufacturing plants of all sizes.
From machinery for mining & drilling, formwork machines, automated storage systems to conveyor systems and blast furnaces.

CE marking and conformity assessment throughout all life stages of a tunnel boring machine for copper mining in Australia.

CE marking and conformity assessment throughout all life phases of a tunnel boring machine for copper mining in Australia

easyCE supports the entire conformity assessment process, including risk assessment, up to the ready-to-sign conformity declaration for all life phases of a tunnel boring machine for copper mining in Australia. The entirely new concept of using multi-arm cutting heads required special attention during the process. In addition to conventional regulations, specific safety and technical requirements applicable in Australia were considered. Intensive collaboration with the manufacturer and their Australian client was required.

Considering: 2006/42/EG, 2014/30/EU, 2014/68/EU, DIN EN 12111, DIN EN 474-1 etc.

CE marking and conformity assessment of high-bay storage with autonomous robot loading and unloading.

easyCE supports the entire conformity assessment process, including risk assessment up to the ready-to-sign conformity declaration for the entire high-bay storage system with automatic lift for use as small parts storage in industrial plants. Particular consideration was given to the hazards in maintenance or troubleshooting scenarios.

CE marking and conformity assessment of high-bay storage with autonomous robot loading and unloading.
Conformity of conveyor systems and belt scrapers for universal use, such as the transport of bulk materials in mining.

Conformity of conveyor systems and belt scrapers for universal use, such as the transport of bulk materials in mining.

easyCE supports the entire conformity assessment process, including risk assessment according to ATEX, up to the ready-to-sign conformity declaration for conveyor belt scrapers for universal use. Special attention was given to injury risks from heavy components during the 'assembly' and 'maintenance' life phases.

Frequently asked questions

FAQ

Which special machinery and production systems (linked facilities) require CE marking?

In summary, all products falling within the scope of one of the 26 CE directives & regulations undergo a conformity assessment process and require CE marking. (Manufacturing) systems typically contain moving mechanical parts and are powered by electricity in the vast majority of cases. Therefore, they fall under the Machinery Directive as well as EMC-Directive and also Low-Voltage Directive. Among the special machinery and production systems requiring CE marking are particularly:

  • Robotic systems
  • Interconnected manufacturing systems and production lines in all industries, such as interconnected manufacturing systems for the chemical, pharmaceutical, and automotive industries
  • Interfaces and automations between different parts of systems
  • Laser systems
  • Test benches
  • Blast furnaces and foundry plants
  • Tunnel boring machines and any machinery used in mining (often necessitating the application of the ATEX directive for hazardous areas)
  • All kinds of conveyor belts
  • All equipment for drilling and extracting petroleum and gas (usually the ATEX directive for hazardous areas applies additionally)
  • Specialized machine tools
  • Custom-made equipment

What is a linked system that requires CE marking according to the Machinery Directive?

Multiple machines that are operated in connection with each other and arranged in a way that they function as a whole. Moreover, they form a unified entity in terms of safety (e.g., shared "emergency stop"). This is often the case with robot-assisted manufacturing systems and assembly lines. Such machines are referred to as interconnected systems, machine sets, or complex systems.

Who is responsible for the conformity assessment and CE marking of a production plant (interconnected system)?

The manufacturer of the interconnected system or production plant is responsible for the conformity assessment and CE marking. This responsibility applies even if the system consists of various machines manufactured by different entities if the interconnected system or production plant is solely created and used for internal purposes, without being placed on the market, the manufacturer is still required to conduct a conformity assessment and apply a CE marking to the complete interconnected system. Even if the individual components or machines within the interconnected system have their own CE marking, the entire system as a whole must undergo the conformity assessment process again for compliance purposes.

Which directives are to be applied in the conformity assessment and CE marking of special machinery and manufacturing plants?

easyCE observes that in the CE marking of special machinery and manufacturing plants, the following directives and regulations are generally applicable:

Which documents and records must I, as the manufacturer of special machinery and equipment, provide to the customer regarding CE marking?

You are obliged to provide at least one complete and accurate Declaration of Conformity, specifying, among other things, the directives and harmonized standards applied during the conformity assessment and risk assessment. Furthermore, you must supply a correct user manual as the contents of the user manual are specified in various standards. easyCE can assist you in ensuring that you do not expose yourself to the risk of flawed documentation.

Can easyCE also assist with placing special machinery and production facilities on the market in the legal framework of the United States of America (USA)?

Yes, easyCE can assist you in evaluating your product according to U.S. requirements and help you create the necessary documentation.

Do hydraulic and pneumatic special machinery and equipment require CE marking?

Yes, Hydraulic and pneumatic products are considered as machinery according to the Machinery Directive. Therefore, the conformity assessment procedure must be conducted, and a CE marking must be affixed.

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RELEVANT ARTICLES & EXPERTISE

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