The machinery directive, of which there is the new edition of the 12-29-2009, defines “machine” a set of mechanical parts of which at least one is mobile because of the effect of a non-human force, and this strength may be already present or applied later.
With those (category Associations firstly) who would like that their products are “not machines”, simply because there is no longer the engine or the plug is missing, as if a pump become machine only when there is the electrician who puts on the engine, taking on all the burden of marking. Comfortable, don’t you think?
The new directive on machinery requires the EC mark for placing on the European market the machines and the almost machines, and this is the same for the imported, both new and used.
The subject that must affix the marking in accordance with the new directive machines is the manufacturer or his delegate, providing that at least one of the two is legally within the European Community. In the absence of this condition, the person obliged to do it is the importer.
Let’s have a look about how to affix the CE mark on a machine.
The new machine directive indicates that already in the design phase it is necessary to respect regulations about security, because it is logical that a machine will be built in a safe manner if the designer provides how to avoid the dangers or reduce risks to the lowest possible level.
Therefore in the design phase they must produce a document called “analysis of risks” , in which there are highlighted the dangers of the machine, the measures designed to reduce the risks and possibly the indication of the residual risks.
In this stage it is fundamental to look at the “essential requirements for safety and health“, which are shown in a chapter of the Directive machines and that identify the main aspects of risk to be taken into consideration in the design and construction of the machine.
From the design then we pass to the construction, of course looking at the results of risk analysis and respecting it.
In the constructive phase it is necessary to adopt all the criteria and methods to build the machine in a secure way and it is important to demonstrate that the product respects the requirements prescribed on the design.
Of course it is not sufficient to “work well,” but it is necessary to demonstrate it, and each organization will take the procedures that for them are the best. The only certain thing is that these procedures must be formalized, that is written in a coherent and respectful way from the Rules es. ISO 9001-2008.
To build a machine it is necessary to have drawn up a separate basis, a project, plans to plant, circuits, in any case the documentation that shows to those who build and for the memory of what it is composed and how the machine is built.
Of course it is necessary to know also by who and when the machine was built and in addition there must be an identification of the same through the registration number.
The machine after being constructed and properly tested with the agreed that shows the extremes of the tests, may be put on the market only if accompanied by a manual of installation, use and maintenance, within which there must be located either printed or attached the declaration of conformity and a reproduction of the label.
The label with the EC mark and other data required by the Directive machinery must be applied to the machinery and written in an indelible way according to the resistance criterion of CANCELLATION also provided by the rule.
The company must have copies of:
- declaration of conformity of the machine
-user manual of the model
-a copy of the model label EC
-documentation of production of the machine for traceability
-documentation of the tests
There must be available on the authority’s request all the other documents:
-the technical file
-the data related to the supplies of all the materials and components
-the documented procedures of production
I am currently designing a Spooling unit for a client who have asked that it conforms to the new eu machine directive. The main Frame of the unit is to DNV 2.7/1 which would be all certified for offshore use. The unit will have an air driven gearbox which in effect, rotates the drum inside the unit. I am unsure as to what I require to ensure that this unit will be EU compatible?… Once I have all documentation in place for the gear box and main unit, is it then just a self delaration of conformity and we affix a CE mark on the unit?.. or do we need a governing body to come in and assess the unit to make sure it is up to standard?
Dear Mr Johnston,
in your case you don’t need to contact a Notified Body for your product. In fact you can apply the CE mark as self declaration. As a machine, your product must respect the Machine Directive in order to be sold in Europe. But you must have the Technical File, that is a collection of various documents, such as Risk analysis, Declaration of Conformity, Standards, User manual, sample of CE label, etc). We can also check the conformity of your Spooling unit.
We can help you in fulfilling this task. This is exactly our job. If you are interested, we can prepare a offer, that will be sent via E-mail, privately.
Thanks for your interest in us and trust.
Best regards.
Vanni Spera
Dear Sir,
Good day!
We are the supplier of marine engines and generators and also suppliers of marine hydraulic equipments and spare parts. If you are interested in buying any of the machinery than please contact to us.
Thanks with regards,
Ruby Sharma
Marine Care