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Machinery and Assemblies


What is covered by machinery and assemblies?

The Machinery Directive includes, for example, stand-alone machinery, but also machinery that have to be installed somewhere and cannot be used on itself. Also included are parts that are used on machinery, these are the so-called 'exchangeable tools'. You will find the complete list of this scope in the CE Tool. Take a good look at this list because then you know if your product is included or not. The CE Tool will guide you step by step.


Multiple directives may apply to your machinery
Most machinery are connected to the mains. In that case your product also has to meet the requirements regarding electricity. You will find these requirements in the Low Voltage Directive. If there is electronics in the machinery, your product also has to meet the requirements with regard to EMC. Whether this applies to your product or not, you can easily check in the CE Tool by selecting the questions whether 'the product is connected to the electricity grid', or 'electronics in it', etc. The CE Tool then generates the mandatory requirements for you.

CE Tool example: More applicable directives

What is excluded from the directive?
When you finished the above steps, you need to execute the 'exceptions' wizard. Look carefully in that list if your machinery is not excluded. For example, if your machinery is intended for the fair, then this is excluded. This is also the case if your machinery is used for military purposes. There are several exceptions so please check carefully whether your product is on that list or not.


Check the safety requirements; the risk analysis
After finishing the 'exceptions' wizard, we recommend starting with the risk analysis. With the risk analysis you determine whether your machinery meets the legal safety requirements. A valuation method is also included in the risk analysis. This method is based on the widely used risk graph 'Fine & Kinney' and harmonized standard EN-ISO 12100:2010. With this risk graph you can determine whether you have to solve a risk immediately or whether this has a lower priority. A technical measure could be shielding of rotating parts. After this measure you can reassess the risk and if that's OK, then that point is 'OK'. If not, you may have to think of another measure, for example a control measure to safeguard the residual risk. In the risk analysis you have to take into account that your customer can misuse your machinery. Where necessary you have to warn for residual risks in your user manual and on the product.

CE Tool: Risk assessment Machinery Directive (possibly in combination with other directives)

What should be in the manual?
You are obliged to provide a manual, but what should be mentioned? In the CE Tool you will find a list of requirements for the user manual. You can find this file in the 'user manual' folder. If you already have a manual, check whether it meets these requirements. And if not, you can use this file as a guide for drawing it up. If you also make other products that are subject to different requirements, the content of the file is often different. So be careful with that.


What should be on the type plate / CE label?
There are also demands for the nameplate or label that you affix to your product. In the folder 'Type plate / label' you can generate an example that meets the legal requirements. Note that the entry fields with * are mandatory fields. If you also create other products in the CE Tool where other requirements apply, then there are often other required fields. So check this file for each product that you create in the tool.

CE Tool example: Creating a type plate / CE label online (You can always adjust it online or in WORD if desired)

The Declaration of Conformity?
You also have to provide a so-called 'Declaration of Conformity' (DoC) with each product. In this DoC you declare that your product meets the legal requirements. You can generate this DoC in the Declaration of Conformity folder. Note that the entry fields marked with * are mandatory fields. If you also create other products in the CE Tool where other requirements apply, then there are often other mandatory fields. So please pay attention.

CE Tool example: Creating a Declaration of Conformity online (You can always adjust it online or in WORD if desired)

Which technical documentation must at least be present?
You are obliged to draw up a so-called 'Technical File', but what should be included? In the CE Tool you will find a list of requirements for your Technical File. You can find this file in the 'Technical Documentation' folder. Please check if your documents meet these requirements. If you also make other products with other requirements, the content of this file can be (very) different. So please be careful that you check the requirements in this file for each product.


Does the product has to be tested?
For most products CE-marking can be done by the manufacturer himself and intervention of a so called Notified Body is not necessary. However, this can be mandatory if your product is risky. But, what is 'risky'? In the folder 'Test reports / certificates' you will find the demands in which cases a product has to be externally tested. In most cases where a machinery is built up from ready-made parts (with CE), this is not necessary. Always ask for multiple quotes and check that the NoBo only offers tests that are mandatory! If you need help, send an e-mail to Euronorm Tools.


Document control
If you have gone through the above steps, it is always possible to have your CE file checked by us. We then indicate whether you have completed all points sufficiently.


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