PAC - Frequently Asked Questions - General

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Frequently Asked Questions

We have collated a comprehensive list of questions that we are asked. If we have made any omissions and you wish to add to this list, or if you would like to find out more about our services, contact us for more details.

Category: General

Are there other European Directives that might apply to my product?

Complying only with the Machinery Directive 2006/42/EC often isn't enough. There are other environmental issues to consider, such as how much noise is emitted from the product, any radio interference it may emit (or be adversely affected by) and whether the machine is intended to be used in an area where explosive atmospheres are present. In this regard, you may need to refer to European Directives 2000/14/EC Noise Emissions for equipment used outdoors, 2004/108/EC Electromagnetic Compatibility (EMC) and 94/9/EC Equipment for use in potentially explosive atmospheres.

Do I need to have ISO9001?

If you plan on producing several units following your initial prototype, you need to ensure that each subsequent product also complies with the requirements of the EC Directives. This means that you need the relevant internal control measures in place to ensure that, if the specification of the product does change, the product is still compliant. It is usually not essential that you possess ISO9001 certification however, you should ensure that you have adequate quality control procedures, which are documented, that cover for example engineering, manufacturing and purchasing processes.

How do I get a CE certificate for my product?

In order to put the CE mark on your product and sell it in Europe you must ensure that it complies with the requirements of all of the relevant European Directives. If your product is intended to lift goods or persons, or both, then it will likely fall within the scope of the European Machinery Directive.

I’ve heard about self-certification, can I self-certify my product?

Self-certification is a procedure whereby a manufacturer declares that his product complies with the requirements of the relevant Directive, without the assistance of a notified body. With regard to the Machinery Directive, if the product falls within certain categories of equipment however, the manufacturer must apply all of the requirements of an applicable harmonised European standard. If the requirements are not or cannot be fully met then the manufacturer must involve a notified body, and the product may need to be submitted for a type examination.

Is my product covered by the Machinery Directive?

'Machinery' is roughly defined in the Machinery Directive 2006/42/EC as 'an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application'. This assembly may be stand-alone or be connected on site for its power source, be permanently installed on a means of transport or in a building or structure, or may even be only partly completed. If the product is intended for lifting loads by direct human effort this is also covered by the Directive.

Is there a European Standard that applies to my product?

European standards are being developed and revised on a continual basis by technical committees throughout Europe. It can often be difficult to identify which standard or standards are applicable to your product. The European Union publish what is termed an 'Official Journal', in which all harmonised standards are listed, that is those which may be used in order to comply with the relevant EC Directives. With regard to lifting equipment there are many standards already published which cover many different types of equipment. However, if your product does not directly fall within the scope of a European standard, it may be necessary to apply the requirements of one or more standards.

What do you mean by a technical file?

A technical file is a document, which can either be held in a hard copy format or files on your computer, which is used to demonstrate that the product complies with the relevant European Directive. Normally, a file would contain documentation such as drawings, calculations, risk assessment, test reports and user instructions. The nature and extent of the documentation depends very much on the type and complexity of the product. The manufacturer is responsible for creating the technical file, which must be retained for at least 15 years following the date of manufacturing, or after the last unit has been produced.

What is a Type Examination?

A type examination is a process undertaken by an EC Notified Body in order to verify that the manufacturer's product does indeed comply with the relevant European Directive(s). The notified body will review the manufacturer's technical file and must retain a copy for at least 15 years following the date of manufacturing, or after the last unit has been produced. The notified body will, normally, also wish to witness tests of the product and undertake a physical inspection. Once the process is complete, the notified body will issue an EC type examination certificate for that product to the manufacturer.

What is an EC Notified Body?

An EC notified body is an organisation that has been designated by the government of a European country as being an expert in that particular product field. The organisation must be able to demonstrate that they have the necessary expertise, impartiality and procedures to enable them to undertake EC type examinations for certain types of products. Some notified bodies are appointed to undertake type examinations on many different types of equipment, whereas other specialise in certain types of product.