CE MARKING FOR
MANUFACTURING AND
PRODUCTION FACILITIES
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Declaration of conformity completed!- Risk assessment done!
- Applicable standards & RL applied!
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Plant manufacturers usually take responsibility for creating and proving the CE marking.
We advise plant manufacturers, for the benefit of their customers and a competitive advantage, to take over the CE marking and technical documentation of the plant. We also recommend to study the special regulations, e.g. in the food and pharmaceutical sector, in the early stages and to consider them in the design in order to avoid additional effort in conformity validation. Please note that correct operation and assembly instructions in the local language of the place of use are a central component of product conformity.The experts at easyCE are available to answer all your questions about conformity and will be happy to assist you.
Operators always have the obligation to prove CE conformity and usually also the responsibility for creating the CE mark.
Operators may only use production and manufacturing facilities marked with the CE mark, as they must guarantee their employees work on conforming and safe machines. Conformity often has to be demonstrated to auditors, particularly in the food and pharmaceutical sectors. This also applies to used and old facilities. To ensure a lean adaptation of the CE marking, we advise operators to only use CE-marked components on self-built or extended systems. If the entire system is made by a commissioned plant builder, we advise getting the CE marking and the complete technical documentation created by the same.The experts at easyCE are available to answer all your questions about conformity and will be happy to assist you.
Exporters are usually responsible for providing proof of the CE marking.
If you export machines to a country in the European Economic Area and the machine is only transferred to your customer after import, you are responsible for the CE marking. We advise exporters to be prepared to demonstrate product compliance with all applicable rules to customs and other regulatory authorities. For competitive reasons, we also always advise exporters to take responsibility for CE marking of the exported machines. If you are exporting a machine to the UK, we will be happy to help you achieve UKCA compliance.The experts at easyCE will be happy to help you prepare or check the conformity assessment documents, which include product analysis, risk assessment, nameplate and the final declaration of conformity. We also check your operating instructions and their contents for conformity.
Importers are at least responsible for providing evidence of CE marking.
If you import machines from a third country into a country in the European Economic Area, you are responsible for ensuring that the machines have a CE marking and are compliant with all applicable directives and standards. You must be able to prove this to customs and other supervisory authorities, otherwise the import may be stopped at your expense. You should therefore have received all the necessary documents for all product components and evidence of correct conformity assessment from the manufacturer before import. Depending on the contractual agreement, the importer may also be responsible for creating the CE marking. Please remember that correct operating instructions in the respective national language are also part of product conformity.The experts at easyCE will be happy to help you with any questions you may have about compiling the documents for conformity assessment, which include product analysis, risk assessment, nameplate and the final declaration of conformity. We also check your operating instructions and their contents for conformity.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.
- Sie stellen CE-kennzeichnungspflichtige Produkte her.
- Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
- Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.
easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.
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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
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 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.
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.
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:
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.
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.
RELEVANT ARTICLES & EXPERTISE
Further articles relevant to general mechanical engineering:
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